Actively Recruiting
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
Led by Quanta Medical · Updated on 2025-03-20
202
Participants Needed
15
Research Sites
351 weeks
Total Duration
On this page
Sponsors
Q
Quanta Medical
Lead Sponsor
C
Cousin Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Whether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip/shoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture. The "Sterile Self Locking Polymer Cerclage System" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications. Thus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care. SERRE is a 36 months follow up study in two arms : * Experimental group: "OrthoLoop cercalge" * Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints. The main objective of this study is to assess the role of "OrthoLoop cerclage" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.
CONDITIONS
Official Title
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with femoral or humeral fracture requiring one or more cerclages and meeting at least one of the following:
- Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) treated with plate and screw or intramedullary nailing plus cerclage(s)
- Traumatic fracture of femur or humerus requiring prosthetic rehabilitation with cerclage(s)
- Peri-prosthetic fracture of femur or humerus
- Prosthesis revision (hip, knee, shoulder, elbow) needing cerclage(s)
- Fixation performed with Sterile Self Locking Polymer Cerclage System or standard care cerclages
- Age 18 years or older
- Provided free, informed, written consent to participate
- Able to communicate in French
- Affiliated with or entitled to a social security system
You will not qualify if you...
- High-energy injury
- Damage to other long bones associated with fracture
- Fracture extending to joint surface with displacement
- Severe disease that could affect study results or be life-threatening
- Current infection
- Allergy to any medical product components
- Pregnant or breastfeeding women
- Expected unavailability during the study
- Participation in another clinical trial within 3 months before inclusion
- Inability to understand or sign informed consent due to language or psychological reasons
- Deprived of liberty by administrative or judicial decision or under guardianship
AI-Screening
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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
Research Team
M
Marc Saab, Dr
CONTACT
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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