Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-19 @ 10:36 PM
Study NCT ID:
NCT03721835
Status:
TERMINATED
Last Update Posted:
2023-09-25
First Post:
2018-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Femoral Neck Fracture System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Karlie.Morgan@smith-nephew.com', 'phone': '+1.512.496.7507', 'title': 'Karlie Morgan', 'organization': 'Smith+Nephew, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of surgery through the 1 year follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Closed head injury', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ground level fall', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness to right foot', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Screw fracture (Posterior, Proximal), Screw back out (Anterior, Proximal)', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "End stage Parkinson's Disease", 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'St. Elevation Myocardial Infarction', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot infection', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non union', 'notes': 'Device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reoperation Rate at One Year Post-operation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'categories': [{'title': 'Reoperation', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Reoperation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Reoperation for any reason from time of implantation to one-year post operation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'When study was terminated, only 3 participants completed their one year follow up visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intraoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Documentation of any complications related to the implantation of the device', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Classification of Quality of Fracture Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'title': 'Operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade I', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade I', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade I', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade I', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Grade I', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Operative, 6 weeks, 3 months, 6 months, and 1 year', 'description': 'Appropriate reduction was defined as the principal compressive trabeculae measuring \\>160° in the AP view and \\<5° of posterior angulation in the lateral view. Fractures were then classified as:\n\n* Grade I\n* Grade II\n* Grade III\n\nIf reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants Analyzed indicates the data available for each given time frame as specified.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'title': 'Pre-Operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.00', 'spread': '28.06', 'groupId': 'OG000'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.30', 'spread': '37.88', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.60', 'spread': '29.79', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '25.00', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year', 'description': "The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen.\n\nThe Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Quality of Life - EQ-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'title': 'Pre-Operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3453', 'spread': '0.3594', 'groupId': 'OG000'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5164', 'spread': '0.2612', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6724', 'spread': '0.2711', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8938', 'spread': '0.1366', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8347', 'spread': '0.1481', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year', 'description': "The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels:\n\n* 1= no problems\n* 2= slight problems\n* 3= moderate problems\n* 4= severe problems\n* 5= extreme problems\n\nThe respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Timed Up and Go (TUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '17.09', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '27.48', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '10.53', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '3.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks, 3 Months, 6 Months, and 1 year', 'description': 'The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Active Straight Leg Raise (ASLR) Assessment: Evaluation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': '0- Not difficult at all', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '1- Minimally difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '2- Somewhat able to do', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '3- Fairly difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '4- Very difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '5- Not able to do', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': '0- Not difficult at all', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '1- Minimally difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '2- Somewhat able to do', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '3- Fairly difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '4- Very difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '5- Not able to do', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': '0- Not difficult at all', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '1- Minimally difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '2- Somewhat able to do', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3- Fairly difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4- Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5- Not able to do', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': '0- Not difficult at all', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '1- Minimally difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2- Somewhat able to do', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3- Fairly difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4- Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5- Not able to do', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Weeks, 3 Months, 6 Months, and 1 year', 'description': 'The ASLR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Participants will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the participant for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Construct Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-operative', 'description': 'Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed indicates available participant data for the time frame specified.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'classes': [{'categories': [{'measurements': [{'value': '4.90', 'spread': '1.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During hospitalization', 'description': 'Time spent in hospital measured by the number of days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Participant not able to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Revision of the components of the study device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Sponsor terminated study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Femoral Neck Fracture System', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture\n\nCONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '15.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White/caucasian', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Black/African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Alaskan native/American indian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-injury Ambulatory Status', 'classes': [{'categories': [{'title': 'Unaided', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Using a cane', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Using a walker', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Bed to chair', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 1259314, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-05T13:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2018-10-19', 'resultsFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-22', 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reoperation Rate at One Year Post-operation', 'timeFrame': '1 year', 'description': 'Reoperation for any reason from time of implantation to one-year post operation'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Intraoperative Complications', 'timeFrame': '7 days', 'description': 'Documentation of any complications related to the implantation of the device'}, {'measure': 'Classification of Quality of Fracture Reduction', 'timeFrame': 'Operative, 6 weeks, 3 months, 6 months, and 1 year', 'description': 'Appropriate reduction was defined as the principal compressive trabeculae measuring \\>160° in the AP view and \\<5° of posterior angulation in the lateral view. Fractures were then classified as:\n\n* Grade I\n* Grade II\n* Grade III\n\nIf reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views.'}, {'measure': 'Visual Analogue Scale (VAS) for Pain', 'timeFrame': 'Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year', 'description': "The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen.\n\nThe Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip."}, {'measure': 'Quality of Life - EQ-5D-5L', 'timeFrame': 'Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year', 'description': "The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels:\n\n* 1= no problems\n* 2= slight problems\n* 3= moderate problems\n* 4= severe problems\n* 5= extreme problems\n\nThe respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state."}, {'measure': 'Timed Up and Go (TUG)', 'timeFrame': '6 Weeks, 3 Months, 6 Months, and 1 year', 'description': 'The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor.'}, {'measure': 'Active Straight Leg Raise (ASLR) Assessment: Evaluation Score', 'timeFrame': '6 Weeks, 3 Months, 6 Months, and 1 year', 'description': 'The ASLR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Participants will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the participant for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do).'}, {'measure': 'Number of Participants With Construct Failure', 'timeFrame': '6 months post-operative', 'description': 'Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'During hospitalization', 'description': 'Time spent in hospital measured by the number of days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Femoral Neck Fracture', 'Hip', 'Broken hip', 'CONQUEST FN', 'Hip Fracture'], 'conditions': ['Femoral Neck Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.', 'detailedDescription': 'The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures.\n\nThis study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be 18 years of age or older\n2. Must provide written informed consent\n3. Willing to make all required study visits for one year post-operation\n4. Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.\n\nExclusion Criteria:\n\n1. Subject with known sensitivity or allergies to stainless steel\n2. Subject with fracture occurring more than 7 days prior to surgery\n3. Subject has more than one fracture on the hip requiring surgery\n4. Subject is considered obese by a Body Mass Index \\> 40 at the time of surgery\n5. Therapy with another investigational agent within thirty 30 days of screening\n6. Subject has emotional or neurological condition that precludes cooperation and compliance\n7. Subject has undergone previous surgery on hip.\n8. Subject has severe bow of the target hip or gross distortion of the femur.\n9. Current systemic therapy with cytotoxic drugs\n10. Subject has a physical condition that would preclude adequate implant support or impede healing (e.g. blood supply impairment, insufficient bone quality or quantity, or an active local or systemic infection).'}, 'identificationModule': {'nctId': 'NCT03721835', 'acronym': 'CONQUEST FN', 'briefTitle': 'Safety Study of Femoral Neck Fracture System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures', 'orgStudyIdInfo': {'id': '18-3047-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control femoral neck fracture system', 'description': 'This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture', 'interventionNames': ['Device: CONQUEST FN Femoral Neck Fracture System']}], 'interventions': [{'name': 'CONQUEST FN Femoral Neck Fracture System', 'type': 'DEVICE', 'description': 'Fracture fixation device consisting of a single plate and three screws', 'armGroupLabels': ['Control femoral neck fracture system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Orthopaedic Trauma Institute Navicent Health Medical Center', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'John Peter Smith Hospital', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78829', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health Science Center San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Karlie Morgan', 'role': 'STUDY_CHAIR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}