Comparing a new polymer cerclage system to standard cerclages for femoral fractures
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.
This study is testing a new type of plastic wrap for fixing thigh bone fractures to see if it works better and causes fewer problems than the usual metal wraps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Quanta Medical Industry-sponsored |
| Locations | 15 sites (Agen, France and 14 other locations) |
| Trial ID | NCT05087667 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a novel polymer cerclage system in comparison to traditional metal cerclages used in the treatment of femoral and humeral fractures. The study aims to determine if the polymer system can reduce complications such as metallosis and soft tissue injury while improving fracture fixation and patient rehabilitation. Participants will include those with various types of fractures requiring cerclage wiring, and the trial will assess outcomes related to bone healing and recovery. The study is being conducted at multiple locations in France.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with femoral or humeral fractures requiring cerclage wiring.
Not a fit: Patients with fractures that do not require cerclage wiring or those unable to communicate in French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes and reduced complications for patients with femoral and humeral fractures.
How similar studies have performed: While the use of cerclage wiring is common, the specific application of a polymer cerclage system is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient with femoral or humeral fracture requiring the installation of one or more cerclage(s) and respecting at least one of the criteria below: * Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) with osteosynthesis by plate and screw or osteosynthesis by Intramedullary nailing associated with the installation of one or more cerclage(s) * Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more cerclage(s) * Peri-prosthetic fracture of the femur or humerus * Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages * who underwent fixation with cerclage wiring (Sterile Self Locking Polymer Cerclage System or other cerclage systems used in standard care) * age ≥18 years * Who have given free, informed and written consent to participate in the study * Patient able to communicate in French * Patient affiliated to a social security system or entitled to a social security system Exclusion Criteria: * high-energy injury, * associated damage to other long bones, * fracture extension to the articular surface with displacement * Severe disease that could interfere with the study results or be life threatening * Patients with an infection * Allergy to any component of the medical products * Pregnant or breastfeeding women * Anticipated unavailability during the study * Participation in a clinical trial within 3 months prior to the inclusion visit. * Patient with linguistic or psychological incapacity to understand and sign the informed consent. * Patient deprived of liberty by administrative or judicial decision, or being under guardianship.
Where this trial is running
Agen, France and 14 other locations
- Clinique ESQUIROL SAINT HILAIRE — Agen, France, France (Recruiting)
- Hôpital Privé Francheville — Périgueux, France, France (Not_yet_recruiting)
- CH Tourcoing — Tourcoing, France, France (Active_not_recruiting)
- CHU Lille — Lille, Nord, France (Recruiting)
- CH Agen — Agen, France (Recruiting)
- CH Arcachon — Arcachon, France (Active_not_recruiting)
- Clinique de Saint Omer — Blendecques, France (Recruiting)
- CH Le Mans — Le Mans, France (Recruiting)
- CH Libourne — Libourne, France (Recruiting)
- Ch Metz - Thionville — Metz, France (Recruiting)
- CHRU Nancy — Nancy, France (Recruiting)
- CHU Nimes — Nîmes, France (Terminated)
- Polyclinique Du Parc — Saint-Saulve, France (Recruiting)
- CHU Toulouse — Toulouse, France (Terminated)
- CH Valenciennes — Valenciennes, France (Recruiting)
Study contacts
- Study coordinator: Marc Saab, Dr
- Email: b.hill@quanta-medical.com
- Phone: +33 (0) 1 47 08 63 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.