Comparing a new polymer cerclage system to standard cerclages for femoral fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique ESQUIROL SAINT HILAIRE
  Agen, France, France Recruiting
• CHU Lille
  Lille, Nord, France Recruiting
• CH Agen
  Agen, France Recruiting
• Clinique de Saint Omer
  Blendecques, France Recruiting
• CH Le Mans
  Le Mans, France Recruiting
• CH Libourne
  Libourne, France Recruiting

Study contacts

• Study coordinator: Marc Saab, Dr
• Email: b.hill@quanta-medical.com
• Phone: +33 (0) 1 47 08 63 41

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.