Femoral Fracture Clinical Trial
Official title:
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
The objective of this prospective PMCF study is to collect data to confirm safety, performance and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures. The primary endpoint is the assessment of performance by analyzing fracture healing. The secondary endpoints are the assessment of safety, clinical benefit and post-op fracture related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group. ;
| 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 | |
| Completed |
NCT02983344 -
Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia
|
N/A | |
| Terminated |
NCT00764959 -
Retrospective Study of the Linear™ 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 |
NCT05523635 -
Post Market Clinical Evaluation of Gamma 4
|
||
| 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®
|