Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 3:51 AM
Study NCT ID:
NCT03431857
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2018-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi Centre Study on TESS V2 Shoulder System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emilie.rohmer@zimmerbiomet.com', 'phone': '+41588548210', 'title': 'Emilie Rohmer, Clinical Ops manager', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study.', 'description': 'Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.', 'eventGroups': [{'id': 'EG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 16, 'seriousNumAtRisk': 106, 'deathsNumAffected': 5, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heterotopic ossification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain, paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder injury', 'notes': 'Due to fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biceps rupture', 'notes': 'On previous tenodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reflex sympathetic syndrom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative inflammation suspected', 'notes': 'Resolved with no further consequences', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acromion inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acromial fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Screw breakage', 'notes': 'During screwing of inferior screw, the screw touched the Fukuda retractor and broke. Screw was maintained in place, and no problem occurred further.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Revision', 'notes': "4 due to dislocation, 1 due to glenoid loosening after a fall, 1 due to patient's dissatisfaction because of limited mobility.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumbar surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder surgery', 'notes': 'Other shoulder-related surgical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elbow arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'notes': 'Death occurred in 1 patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'notes': 'Death occurred in 1 patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'notes': 'Death occurred in 1 patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture thoracical vertebrae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung edema', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'notes': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee wound', 'notes': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pubis bone fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wrist fracture', 'notes': 'Conservative treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Humerus fracture', 'notes': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder fracture', 'notes': 'Conservative treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudoarthritis rhizomelic', 'notes': 'Hospitalization, infiltrations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy and athrosis of inferior limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radius fracture', 'notes': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporosis, fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acromio-clavicular arthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rachialgia and scapulalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cubital and Carpal Tunnel Syndrome', 'notes': 'Neurolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Humerocubital ostephytes', 'notes': 'Neurolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dementia + respiratory infection', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'notes': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress incontinence', 'notes': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cement effraction', 'notes': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parkinson', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperalgic lumbosciatic', 'notes': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Constant Shoulder Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.36', 'spread': '13.95', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '9.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 99 (pre-operative) and 50 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Active Anterior Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.02', 'spread': '36.3', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '131', 'spread': '19.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 92 (pre-operative) and 50 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Active Lateral Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.57', 'spread': '40.17', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105.70', 'spread': '17.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 91 (pre-operative) and 50 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Active External Rotation RE1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.45', 'spread': '18.58', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.80', 'spread': '18.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 96 (pre-operative) and 50 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Active External Rotation RE2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.22', 'spread': '26.1', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.94', 'spread': '17.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 76 (pre-operative) and 49 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Passive Elevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112.32', 'spread': '27.40', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '140.90', 'spread': '18.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 95 (pre-operative) and 50 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Passive External Rotation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.37', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.47', 'spread': '19.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of cases for each time point: 95 (pre-operative) and 49 (5 years follow-up).'}, {'type': 'SECONDARY', 'title': 'Radiographic Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'title': 'Immediate post-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '6 weeks follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '1 year follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '2 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '3 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '4 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '5 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}, {'units': 'radiographies', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.', 'description': 'A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported.', 'calculatePct': False, 'unitOfMeasure': 'changed radiographies compared to pre-op', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'radiographies', 'denomUnitsSelected': 'radiographies', 'populationDescription': 'Number of radiographies analysed: 90 immediately post-operative, 83 at 6 weeks follow-up, 85 at 6 months follow-up, 75 at 1 year follow-up, 59 at 2 years follow-up, 36 at 3 years follow-up, 22 at 4 years follow-up, 44 at 5 years follow-up.'}, {'type': 'SECONDARY', 'title': 'Survivorship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}, {'units': 'implanted devices', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '99.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years follow-up', 'description': 'The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively.', 'unitOfMeasure': 'Percentage of implanted devices', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'implanted devices', 'denomUnitsSelected': 'implanted devices', 'populationDescription': 'Number of cases analyzed for each time point: 102 implanted devices (immediate post-operative) and 43 implanted devices (5 years follow-up).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '52 subjects have completed the study, and 50 had complete data (all pages of CRF visit are complete)', 'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73.3', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The gender of 2 patients (1.9% of participants) was unspecified in the CRF.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Height cm', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '163.7', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Height was not available for 4 of the patients.'}, {'title': 'Weight kg', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75.9', 'spread': '17.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Weight was not available for 2 of the patients.'}], 'populationDescription': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-05-30', 'size': 167342, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-27T03:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2018-01-29', 'resultsFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-21', 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Shoulder Score', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.'}], 'secondaryOutcomes': [{'measure': 'Active Anterior Elevation', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees.'}, {'measure': 'Active Lateral Elevation', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees.'}, {'measure': 'Active External Rotation RE1', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees.'}, {'measure': 'Active External Rotation RE2', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees.'}, {'measure': 'Passive Elevation', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees.'}, {'measure': 'Passive External Rotation', 'timeFrame': 'Pre-operative, 5 years follow-up', 'description': 'The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees.'}, {'measure': 'Radiographic Evaluation', 'timeFrame': 'Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.', 'description': 'A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: "unchanged" or "changed" when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of "changed" radiographic evaluations per time point are here reported.'}, {'measure': 'Survivorship', 'timeFrame': '5 years follow-up', 'description': 'The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Shoulder arthroplasty', 'Medical device', 'Shoulder prosthesis', 'Performance'], 'conditions': ['Osteoarthritis Shoulder', 'Fracture', 'Rheumatoid Arthritis', 'Avascular Necrosis', 'Rotator Cuff Tear', 'Revision']}, 'descriptionModule': {'briefSummary': 'This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.', 'detailedDescription': 'The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Except in special cases, the "anatomic" type is indicated for:\n\n * Centered osteoarthritis of the shoulder\n * Humeral head fractures\n * Rheumatoid arthritis (with intact rotator cuff)\n * Avascular necrosis of the humeral head\n* Except in special cases, the "reversed" type is indicated for:\n\n * Offset osteoarthritis of the shoulder\n * Massive and non-repairable rotator cuff tears\n * Rheumatoid arthritis (with degenerative rotator cuff)\n* Revision in cases of:\n\n * Replacement of an "anatomic" prosthesis with a "reversed" prosthesis\n * Conversion of a hemi-arthroplasty into a total arthroplasty\n * Increasing the size of the stem (length and/or diameter)\n * Replacing a glenoid prosthesis\n * Replacing a competitor\'s prosthesis\n * In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis\n* Additional inclusion criteria include\n\n * Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)\n * Willing to return for follow-up evaluations\n\nExclusion Criteria:\n\n* Local or systemic infections.\n* Severe muscular, neurological, or vascular deficiency of the affected joint.\n* Bone destruction or poor bone quality liable to affect the stability of the implant (Paget\'s disease, osteoporosis, etc.)\n* Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.\n* Any concomitant complaint likely to affect the functioning of the implant.\n* Allergy to any of the implant components.\n* Local bone tumors.\n* Patient over 18 under law supervision'}, 'identificationModule': {'nctId': 'NCT03431857', 'briefTitle': 'Multi Centre Study on TESS V2 Shoulder System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System', 'orgStudyIdInfo': {'id': 'ORTHO.CR.E13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TESS V2 Prosthesis', 'description': 'Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.', 'interventionNames': ['Device: TESS V2']}], 'interventions': [{'name': 'TESS V2', 'type': 'DEVICE', 'description': 'Patients requiring the TESS V2 prosthesis.', 'armGroupLabels': ['TESS V2 Prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9100', 'city': 'Sint-Niklaas', 'country': 'Belgium', 'facility': 'Orthokliniek Waasland', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '59', 'city': 'Berck', 'country': 'France', 'facility': 'Institut Calot', 'geoPoint': {'lat': 50.4, 'lon': 1.6}}], 'overallOfficials': [{'name': 'Paola Vivoda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}