Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-03 @ 2:58 PM
Study NCT ID:
NCT02522728
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2015-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Eric.Garling@stryker.com', 'phone': '+31 6 467 135 18', 'title': 'Eric Garling, PhD Snr. Director Medical & Scientific Affairs Europe', 'organization': 'Stryker Orthopaedics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During entire 10 years follow-up of all patients', 'description': 'All serious adverse events and operative site events occuring in this study were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 3, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Total knee replacement', 'notes': 'Contralateral side', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleomorphic Adenoma of Salivary Glands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine Cancer', 'notes': 'Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epileptic fit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'OG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years follow-up', 'description': 'Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number included in the analysis differs from the overall number analysed because that data were not collected.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'OG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}], 'classes': [{'title': 'pre-op assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.43', 'spread': '8.37', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '7.41', 'groupId': 'OG001'}]}]}, {'title': '3 months assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.88', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '91.57', 'spread': '12.65', 'groupId': 'OG001'}]}]}, {'title': '1 year assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.00', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '94.70', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': '2 years assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.00', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '97.39', 'spread': '4.60', 'groupId': 'OG001'}]}]}, {'title': '5 years assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.47', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '98.33', 'spread': '3.42', 'groupId': 'OG001'}]}]}, {'title': '7 years assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.12', 'spread': '11.88', 'groupId': 'OG000'}, {'value': '98.10', 'spread': '4.58', 'groupId': 'OG001'}]}]}, {'title': '10 years assessment score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.06', 'spread': '12.57', 'groupId': 'OG000'}, {'value': '97.78', 'spread': '6.99', 'groupId': 'OG001'}]}]}, {'title': 'pre-op function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.11', 'spread': '11.71', 'groupId': 'OG000'}, {'value': '50.67', 'spread': '12.71', 'groupId': 'OG001'}]}]}, {'title': '3 months function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.80', 'spread': '15.10', 'groupId': 'OG000'}, {'value': '72.17', 'spread': '17.78', 'groupId': 'OG001'}]}]}, {'title': '1 year function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.54', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '85.00', 'spread': '16.76', 'groupId': 'OG001'}]}]}, {'title': '2 years function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.32', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '89.46', 'spread': '15.89', 'groupId': 'OG001'}]}]}, {'title': '5 years function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.89', 'spread': '17.27', 'groupId': 'OG000'}, {'value': '89.79', 'spread': '17.84', 'groupId': 'OG001'}]}]}, {'title': '7 years function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.41', 'spread': '15.70', 'groupId': 'OG000'}, {'value': '88.00', 'spread': '16.42', 'groupId': 'OG001'}]}]}, {'title': '10 years function score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.43', 'spread': '13.26', 'groupId': 'OG000'}, {'value': '91.39', 'spread': '13.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative, 3 months, 1, 2, 5, 7 and 10 years', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'OG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}], 'classes': [{'title': 'pre-op symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.37', 'spread': '18.19', 'groupId': 'OG000'}, {'value': '54.66', 'spread': '20.05', 'groupId': 'OG001'}]}]}, {'title': '3 months symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.67', 'spread': '17.13', 'groupId': 'OG000'}, {'value': '66.11', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': '1 year symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.96', 'spread': '18.72', 'groupId': 'OG000'}, {'value': '76.19', 'spread': '14.99', 'groupId': 'OG001'}]}]}, {'title': '2 years symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.49', 'spread': '18.46', 'groupId': 'OG000'}, {'value': '82.78', 'spread': '15.49', 'groupId': 'OG001'}]}]}, {'title': '5 years symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.47', 'spread': '19.94', 'groupId': 'OG000'}, {'value': '87.80', 'spread': '12.19', 'groupId': 'OG001'}]}]}, {'title': '7 years symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.98', 'spread': '18.58', 'groupId': 'OG000'}, {'value': '87.86', 'spread': '11.73', 'groupId': 'OG001'}]}]}, {'title': '10 years symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.29', 'spread': '18.30', 'groupId': 'OG000'}, {'value': '84.82', 'spread': '14.42', 'groupId': 'OG001'}]}]}, {'title': 'pre-op pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.79', 'spread': '18.56', 'groupId': 'OG000'}, {'value': '43.80', 'spread': '18.57', 'groupId': 'OG001'}]}]}, {'title': '3 months pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.11', 'spread': '15.51', 'groupId': 'OG000'}, {'value': '71.62', 'spread': '20.20', 'groupId': 'OG001'}]}]}, {'title': '1 year pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.77', 'spread': '14.17', 'groupId': 'OG000'}, {'value': '79.81', 'spread': '18.92', 'groupId': 'OG001'}]}]}, {'title': '2 years pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.01', 'spread': '17.32', 'groupId': 'OG000'}, {'value': '87.98', 'spread': '13.75', 'groupId': 'OG001'}]}]}, {'title': '5 years pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.53', 'spread': '23.86', 'groupId': 'OG000'}, {'value': '90.74', 'spread': '13.84', 'groupId': 'OG001'}]}]}, {'title': '7 years pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.37', 'spread': '24.03', 'groupId': 'OG000'}, {'value': '88.19', 'spread': '15.61', 'groupId': 'OG001'}]}]}, {'title': '10 years pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.88', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '88.49', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': 'pre-op ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.16', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '45.07', 'spread': '14.86', 'groupId': 'OG001'}]}]}, {'title': '3 months ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.28', 'spread': '14.82', 'groupId': 'OG000'}, {'value': '73.68', 'spread': '18.70', 'groupId': 'OG001'}]}]}, {'title': '1 year ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.64', 'spread': '17.07', 'groupId': 'OG000'}, {'value': '78.73', 'spread': '19.86', 'groupId': 'OG001'}]}]}, {'title': '2 years ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.61', 'spread': '14.21', 'groupId': 'OG000'}, {'value': '83.85', 'spread': '15.62', 'groupId': 'OG001'}]}]}, {'title': '5 years ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.06', 'spread': '20.82', 'groupId': 'OG000'}, {'value': '87.32', 'spread': '16.98', 'groupId': 'OG001'}]}]}, {'title': '7 years ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.26', 'spread': '20.08', 'groupId': 'OG000'}, {'value': '84.20', 'spread': '19.31', 'groupId': 'OG001'}]}]}, {'title': '10 years ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.53', 'spread': '18.61', 'groupId': 'OG000'}, {'value': '82.82', 'spread': '18.05', 'groupId': 'OG001'}]}]}, {'title': 'pre-op Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.15', 'spread': '25.39', 'groupId': 'OG000'}, {'value': '11.72', 'spread': '12.77', 'groupId': 'OG001'}]}]}, {'title': '3 months Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.80', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '30.70', 'spread': '24.00', 'groupId': 'OG001'}]}]}, {'title': '1 year Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.91', 'spread': '21.84', 'groupId': 'OG000'}, {'value': '37.81', 'spread': '23.65', 'groupId': 'OG001'}]}]}, {'title': '2 years Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.88', 'spread': '27.45', 'groupId': 'OG000'}, {'value': '45.53', 'spread': '22.21', 'groupId': 'OG001'}]}]}, {'title': '5 years Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.32', 'spread': '31.26', 'groupId': 'OG000'}, {'value': '56.46', 'spread': '29.40', 'groupId': 'OG001'}]}]}, {'title': '7 years Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.88', 'spread': '30.68', 'groupId': 'OG000'}, {'value': '44.00', 'spread': '24.58', 'groupId': 'OG001'}]}]}, {'title': '10 years Sport Rec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.67', 'spread': '27.77', 'groupId': 'OG000'}, {'value': '43.75', 'spread': '28.37', 'groupId': 'OG001'}]}]}, {'title': 'Pre-op QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.76', 'spread': '11.55', 'groupId': 'OG000'}, {'value': '24.57', 'spread': '14.46', 'groupId': 'OG001'}]}]}, {'title': '3 months QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.25', 'spread': '17.29', 'groupId': 'OG000'}, {'value': '56.47', 'spread': '22.72', 'groupId': 'OG001'}]}]}, {'title': '1 year QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.84', 'spread': '18.05', 'groupId': 'OG000'}, {'value': '67.63', 'spread': '24.59', 'groupId': 'OG001'}]}]}, {'title': '2 years QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.84', 'spread': '22.14', 'groupId': 'OG000'}, {'value': '79.02', 'spread': '19.70', 'groupId': 'OG001'}]}]}, {'title': '5 years QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.59', 'spread': '24.99', 'groupId': 'OG000'}, {'value': '82.55', 'spread': '18.97', 'groupId': 'OG001'}]}]}, {'title': '7 years QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.54', 'spread': '25.66', 'groupId': 'OG000'}, {'value': '81.25', 'spread': '17.33', 'groupId': 'OG001'}]}]}, {'title': '10 years QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.43', 'spread': '18.79', 'groupId': 'OG000'}, {'value': '63.75', 'spread': '11.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative, 3 months, 1, 2, 5, 7 and 10 years', 'description': 'KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.'}, {'type': 'SECONDARY', 'title': 'Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'OG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}], 'classes': [{'title': 'Descriptive EQ-5D 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Descriptive EQ-5D 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Descriptive EQ-5D 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Descriptive EQ-5D 7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Descriptive EQ-5D 10 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D VAS 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'spread': '14', 'groupId': 'OG000'}, {'value': '83', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D VAS 2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'spread': '18', 'groupId': 'OG000'}, {'value': '84', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D VAS 5 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'spread': '14', 'groupId': 'OG000'}, {'value': '85', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D VAS 7 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'spread': '15', 'groupId': 'OG000'}, {'value': '83', 'spread': '23', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D VAS 10 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'spread': '21', 'groupId': 'OG000'}, {'value': '83', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2, 5, 7 and 10 years', 'description': 'The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.\n\nWith the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.'}, {'type': 'SECONDARY', 'title': 'Investigation of Patient Outcome With Radiographic Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'OG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}], 'timeFrame': '3 months, 1, 2, 5, 7 and 10 years', 'description': 'Plain radiographs will be obtained for assessment of fixation of the device.', 'reportingStatus': 'POSTED', 'populationDescription': 'Plain radiographs were used for disease classification. Additional radiographs were not collected for the assessment of device fixation as the RSA analysis was used as an exact measurement of prosthesis components migration and implant fixation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'FG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not receive randomized study device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon CR: Implantation of Knee Prosthesis'}, {'id': 'BG001', 'title': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.\n\nTriathlon PS: Implantation of Knee Prosthesis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.07', 'spread': '8.11', 'groupId': 'BG000'}, {'value': '67.47', 'spread': '7.64', 'groupId': 'BG001'}, {'value': '67.77', 'spread': '7.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ahlbäck Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Grade 2', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Grade 3', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Grade 5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'According to Ahlbäck system, knee joint osteoarthritis is classified as:\n\ngrade 1: joint space narrowing (less than 3 mm) grade 2: joint space obliteration grade 3: minor bone attrition (0-5 mm) grade 4: moderate bone attrition (5-10 mm) grade 5: severe bone attrition (more than 10 mm)', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'With an alpha of 0.05 and a beta of 0.20 the required sample size in each group is 25 patients. Patients with inadequate marking will be excluded from the study. Taking the latter into account and to compensate for possible lost to follow up, 30 patients will be recruited per study group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2007-08-29', 'size': 439691, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-11T13:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2015-06-11', 'resultsFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-18', 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)', 'timeFrame': '2 years follow-up', 'description': 'Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.'}], 'secondaryOutcomes': [{'measure': 'Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)', 'timeFrame': 'pre-operative, 3 months, 1, 2, 5, 7 and 10 years', 'description': 'The Knee Society Clinical Rating System is comprised of two distinct sub-scores: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.'}, {'measure': 'Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire', 'timeFrame': 'pre-operative, 3 months, 1, 2, 5, 7 and 10 years', 'description': 'KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse outcome).'}, {'measure': 'Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire', 'timeFrame': '1, 2, 5, 7 and 10 years', 'description': 'The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.\n\nWith the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).'}, {'measure': 'Investigation of Patient Outcome With Radiographic Analysis', 'timeFrame': '3 months, 1, 2, 5, 7 and 10 years', 'description': 'Plain radiographs will be obtained for assessment of fixation of the device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee', 'Arthroplasty', 'Implant'], 'conditions': ['Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.', 'detailedDescription': 'The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.\n\nThe evaluation is carried out by a prospective randomised RSA-study with Triathlon CR vs. Triathlon PS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients suffering exclusively from osteo arthritis, Stage II-V \\[Ahlbäck, 1968 391\\] will be operated.\n2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system\n3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.\n4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.\n\nExclusion Criteria:\n\n1. Previous major knee surgery\n2. Other significant disabling problems from the muscular-skeletal system than in the knees\n3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).\n4. Patients with active or suspected infection.\n5. Patients with malignancy - active malignancy.\n6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.\n7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.\n8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.\n9. Female patients planning a pregnancy during the course of the study.\n10. Patients with systemic or metabolic disorders leading to progressive bone deterioration.\n11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.\n12. Patients with other severe concurrent joint involvements, which can affect their outcome.\n13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.\n14. Patients under the protection of law (e.g. guardianship)."}, 'identificationModule': {'nctId': 'NCT02522728', 'acronym': 'TriathlonRSA', 'briefTitle': 'Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis (RSA) Triathlon CR vs. PS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'Evaluation of Triathlon - A New Total Knee Prosthesis System - Roentgen Stereophotogrammetric Analysis Triathlon CR vs. PS', 'orgStudyIdInfo': {'id': 'K-S-015 Triathlon RSA _2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon CR', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.', 'interventionNames': ['Device: Triathlon CR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triathlon PS', 'description': 'Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.', 'interventionNames': ['Device: Triathlon PS']}], 'interventions': [{'name': 'Triathlon CR', 'type': 'DEVICE', 'description': 'Implantation of Knee Prosthesis', 'armGroupLabels': ['Triathlon CR']}, {'name': 'Triathlon PS', 'type': 'DEVICE', 'description': 'Implantation of Knee Prosthesis', 'armGroupLabels': ['Triathlon PS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '281 38', 'city': 'Hässleholm', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm', 'geoPoint': {'lat': 56.15905, 'lon': 13.76638}}], 'overallOfficials': [{'name': 'Sören Toksvig-Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}