Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05087667

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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