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Compares treatment options for Femoral Fracture
Official title Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
ClinicalTrials.gov ID: NCT05087667
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more...
- Peri-prosthetic fracture of the femur or humerus
- Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Agen, France, France
- Périgueux, France, France
- Tourcoing, France, France
- Lille, Nord, France
- Agen, France
- Arcachon, France
- Blendecques, France
- Le Mans, France
- Libourne, France
- Metz, France
- Nancy, France
- Nîmes, France
- Saint-Saulve, France
- Toulouse, France
- Valenciennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Agen, France, France; Périgueux, France, France; Tourcoing, France, France; Lille, Nord, France; Agen, France; Arcachon, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.