Status:
RECRUITING
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
Lead Sponsor:
Quanta Medical
Collaborating Sponsors:
Cousin Biotech
Conditions:
Femoral Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 shoulde...
Eligibility 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.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05087667
Start Date
March 8 2022
End Date
December 1 2028
Last Update
March 20 2025
Active Locations (15)
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1
Clinique ESQUIROL SAINT HILAIRE
Agen, France, France, 47000
2
Hôpital Privé Francheville
Périgueux, France, France, 24000
3
CH Tourcoing
Tourcoing, France, France, 59208
4
CHU Lille
Lille, Nord, France, 59000