Epidemiology of periprosthetic femur fracture around a total hip arthroplasty.
Hans Lindahl
https://pubmed.ncbi.nlm.nih.gov/17477925Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05087667
Outcomes of Polymer Cerclage System OrthoLoop Compared to Standard Cerclage Systems for Managing Femoral and Humeral Fractures
Led by Quanta Medical · Updated on 2025-03-20
202
Participants Needed
15
Research Sites
130 weeks
Total Duration
On this page
Sponsors
Q
Quanta Medical
Lead Sponsor
C
Cousin Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of a new polymer cerclage system called OrthoLoop in managing fractures of the femur and humerus bones, including those around prosthetic hips and shoulders. This study compares OrthoLoop to standard cerclage systems, mainly metallic ones, to see if it improves bone healing and reduces complications. The study focuses on adults aged 18 and older who require cerclage wiring as part of their fracture treatment. Participants receive either the OrthoLoop polymer cerclage device or a standard cerclage system after surgical repair of their fracture. The study is designed with two groups and follows patients for 36 months after surgery. Follow-up visits are scheduled at 6-8 weeks, 3 months, 6 months, and 36 months to monitor healing, pain, device performance, and any complications. During the study, researchers evaluate bone healing success six months after surgery, track the rate and timing of bone union, and observe any rupture or movement of the cerclage devices. Pain levels and surgical details are recorded at multiple intervals. The study also collects data on complications and surgeon satisfaction with the devices. This thorough follow-up aims to provide a detailed assessment of the OrthoLoop system compared to standard care over three years.
CONDITIONS
Brief Title
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient with femoral or humeral fracture requiring one or more cerclages
- Primary femoral or humeral fractures fixed with plate and screw or intramedullary nailing plus cerclage
- Traumatic femur or humerus fracture needing prosthetic rehabilitation with cerclage
- Peri-prosthetic fracture of femur or humerus
- Prosthesis revision (hip, knee, shoulder, elbow) requiring cerclage
- Underwent fixation with polymer or standard cerclage systems
- Age 18 years or older
- Provided free, informed, written consent
- Able to communicate in French
- Affiliated with or entitled to social security system
You will not qualify if you...
- High-energy injury
- Damage to other long bones
- Fracture extending to displaced articular surface
- Severe disease interfering with study or life-threatening
- Current infection
- Allergy to device components
- Pregnant or breastfeeding women
- Expected unavailability during study
- Participation in clinical trial within 3 months before inclusion
- Linguistic or psychological inability to consent
- Deprived of liberty by administrative or judicial decision or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day 0 (surgery day)
Participants undergo implantation of the assigned cerclage system (Polymer Cerclage System OrthoLoop or standard cerclage) during surgery.
1 visit (surgical procedure)
Post-operative Follow-up
Duration - Up to 36 months post-surgery
Participants are followed for up to 36 months after surgery to assess healing, complications, pain, and device performance.
Visits at 6-8 weeks, 3 months, 6 months, and 36 months post-surgery
Trial Site Locations
Total: 15 locations
1
Clinique ESQUIROL SAINT HILAIRE
Agen, France, France, 47000
Actively Recruiting
2
Hôpital Privé Francheville
Périgueux, France, France, 24000
Not Yet Recruiting
3
CH Tourcoing
Tourcoing, France, France, 59208
Active, Not Recruiting
4
CHU Lille
Lille, Nord, France, 59000
Actively Recruiting
5
CH Agen
Agen, France, 47000
Actively Recruiting
6
CH Arcachon
Arcachon, France, 33164
Active, Not Recruiting
7
Clinique de Saint Omer
Blendecques, France, 62575
Actively Recruiting
8
CH Le Mans
Le Mans, France, 72037
Actively Recruiting
9
CH Libourne
Libourne, France, 33505
Actively Recruiting
10
Ch Metz - Thionville
Metz, France, 57085
Actively Recruiting
11
CHRU Nancy
Nancy, France, 54000
Actively Recruiting
12
CHU Nimes
Nîmes, France, 30900
Terminated
13
Polyclinique Du Parc
Saint-Saulve, France, 59880
Actively Recruiting
14
CHU Toulouse
Toulouse, France, 31300
Terminated
15
CH Valenciennes
Valenciennes, France, 59300
Actively Recruiting
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Research Team
M
Marc Saab, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Periprosthetic femoral fractures in total hip arthroplasty - a review.
Faizal Rayan, Fares Haddad
https://pubmed.ncbi.nlm.nih.gov/21157744Periprosthetic femoral fractures around hip arthroplasty: current concepts in their management.
Eleftherios Tsiridis, George Pavlou, Ramakrishnan Venkatesh...
https://pubmed.ncbi.nlm.nih.gov/19462362Impact of intraoperative femoral fractures in primary hip arthroplasty: a comparative study with a mid-term follow-up.
Thomas Ferbert, Ayham Jaber, Nathan Gress...
https://pubmed.ncbi.nlm.nih.gov/31096789Locking plate fixation of periprosthetic femur fractures with and without cerclage wires.
Nabil A Ebraheim, Kyle R Sochacki, Xiaochen Liu...
https://pubmed.ncbi.nlm.nih.gov/24002835Combination of low-contact cerclage wiring and osteosynthesis in the treatment of femoral fractures.
Andrea Angelini, Concetto Battiato
https://pubmed.ncbi.nlm.nih.gov/26983607Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation - a biomechanical study.
Katharina Gordon, Martin Winkler, Thomas Hofstädter...
https://pubmed.ncbi.nlm.nih.gov/27338228Past and present of the use of cerclage wires in orthopedics.
Andrea Angelini, Concetto Battiato
https://pubmed.ncbi.nlm.nih.gov/25186972Cemented total hip replacement cable debris and acetabular construct durability.
Aaron J Altenburg, John J Callaghan, Tameem M Yehyawi...
https://pubmed.ncbi.nlm.nih.gov/19571089Complications of a cable grip system.
C D Silverton, J J Jacobs, A G Rosenberg...
https://pubmed.ncbi.nlm.nih.gov/8792246