Clinical Trials Logo

Clinical Trial Summary

This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment. It is anticipated that a total of 100 subjects will be enrolled at five sites. Total duration of enrollment, 12 month follow-up and analysis is expected to take approximately 30 months. The clinical investigation has been designed to follow the surgeon's standard of care for subjects treated with a cephalomedullary nail for femoral fractures or and deformities, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months.


Clinical Trial Description

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the Gamma 4 System. Enrolled subjects will undergo an initial assessment, with follow-up evaluations at 3 Months, 6 Months, and 12 Months after the index procedure. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months, as measured by the Investigator. Secondary endpoints will include safety through reporting the incidence of device related intra-operative and post-operative adverse events by 12 months, patient reported outcome measures (SF-35v2 and Modified Harris Hip Score), and other specific health outcomes. Efficacy will be assessed through non-inferiority of bone consolidation proportion compared to the pooled literature control, as well as the SF-36 score results by 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05523635
Study type Observational
Source Stryker Trauma GmbH
Contact Rebecca Gibson
Phone 919-915-4426
Email rebecca.gibson@stryker.com
Status Recruiting
Phase
Start date March 6, 2023
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT05515718 - Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures N/A
Recruiting NCT04494672 - A Study to Verify if the Surgery for the Proximal Femur Fracture Can be Improved With the Help of a Navigation System N/A
Unknown status NCT01680120 - Dose Finding Study for Continuous Spinal Anaesthesia Phase 4
Recruiting NCT04015154 - A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
Recruiting NCT04015128 - A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
Recruiting NCT05410587 - Fracture Monitor - Femur N/A
Recruiting NCT05276674 - ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Completed NCT02983344 - Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia N/A
Terminated NCT00764959 - Retrospective Study of the Linearâ„¢ Hip Phase 4
Completed NCT02069327 - The Role of Fat Emboli in the Trauma Inflammatory Response
Completed NCT03856502 - Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures N/A
Recruiting NCT05559736 - Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures N/A
Completed NCT03810092 - Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
Recruiting NCT05087667 - Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) ) N/A
Recruiting NCT05274022 - Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture N/A
Terminated NCT01300520 - The Development of a Surgical Localizing Aid Medical Device N/A
Terminated NCT01141894 - Goal Directed Haemodynamic Treatment for Patients With Proximal Femoral Fracture N/A
Recruiting NCT05668182 - A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects
Recruiting NCT05680987 - Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures N/A
Not yet recruiting NCT04918680 - Prospective Post-market Study Examining the Effectiveness of the EcoFit®