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

Launched by QUANTA MEDICAL · Oct 8, 2021

Keywords

ClinConnect Summary

This clinical trial, called CERCPMCF, is studying a new type of cerclage system called OrthoLoop, which is made from a polymer. Cerclage is a method used to help stabilize fractures in the femur (thigh bone) or humerus (upper arm bone), especially in patients who have had hip or shoulder replacements. The trial aims to compare the effectiveness of this new polymer cerclage with standard metal cerclages commonly used in surgeries. The goal is to see if the new system can improve healing and recovery for patients with these types of fractures.

To participate in the study, patients need to be 18 years or older and have a femoral or humeral fracture that requires the placement of cerclage wiring. This includes those with both primary fractures and fractures that happen around existing hip or shoulder prostheses. Participants will undergo surgery and then be followed for three years, with check-ups scheduled at 6-8 weeks, 3 months, 6 months, and 36 months after surgery. This trial is important because it could help improve the way fractures are treated, leading to better patient outcomes and fewer complications.

Gender

ALL

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.