Clinical Trials Logo

Clinical Trial Summary

The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also increasing, notably due to an older population. Whether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip/shoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture. The "Sterile Self Locking Polymer Cerclage System" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications. Thus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care. SERRE is a 36 months follow up study in two arms : - Experimental group: "OrthoLoop cercalge" - Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints. The main objective of this study is to assess the role of "OrthoLoop cerclage" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05087667
Study type Interventional
Source Quanta Medical
Contact Marc Saab, Dr
Phone +33 (0) 1 47 08 63 41
Email b.hill@quanta-medical.com
Status Recruiting
Phase N/A
Start date March 8, 2022
Completion date October 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 NCT04015128 - A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
Recruiting NCT04015154 - A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
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 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®