NCT05087667

Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )

Outcomes of Adjuvant "Polymer Cerclage System "OrthoLoop" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Quanta Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Fracture

Interventions

Type	Name	Description
DEVICE	Implantation of Ortholoop cerclage	implantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention
DEVICE	Implantation of Cerclage used in current practice	implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention

Timeline

• Start date: 2022-03-08
• Primary completion: 2026-06-01
• Completion: 2028-12-01
• First posted: 2021-10-21
• Last updated: 2025-03-20

Locations

15 sites across 1 country: France