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

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes of Adjuvant Polymer Cerclage System OrthoLoop to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.

Conditions
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Femoral Fracture

Intervention / Treatment
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* Device: Implantation of Ortholoop cerclage
* Device: Implantation of Cerclage used in current practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster's randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polymer Cerclage System OrthoLoop<br>Patients receives Ortholoop Cerclage System | Device: Implantation of Ortholoop cerclage<br>* implantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention<br>|
| Active Comparator: cerclages used in standard care<br>Patients receives cerclages used in standard care | Device: Implantation of Cerclage used in current practice<br>* implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess role of Polymer Cerclage System OrthoLoop 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 fractures of long bones | primary endpoint will be success or failure 6 months after surgery: Success of Sterile Self Locking Polymer Cerclage System to optimize consolidation during 6 months post surgery is defined as: the ability to walk full weight bearing without pain at the fracture site, or return to normal, painless mobility at the fracture site, and radiographs showing signs of bony union with no rupture or migration of the cerclage. Rupture or cerclage migration or nonunion or need for revision of the implant before 6 months is considered as failure. | 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess consolidation rate during 6 months post surgery | Consolidation (or union) is defined as the ability to walk full weight bearing without pain or return to normal, painless mobility at the fracture site , and radiographs showing signs of bony union | 6 months post-surgery | 
| Asses union time | Union time is defined as time from intervention until For Femoral fracture: ability of patient to walk full weight bearing without pain at the fracture site and radiographs showing signs of bony union For humeral fracture: The patient regained full mobility without pain at the fracture site. | 3, 6 and 36 months post-surgery | 
| Assess rupture and migration rate of the cerclage after surgery throughout the follow-up | Rupture and migration of the cerclage are confirmed on X Ray imaging. | 3, 6 and 36 months post-surgery | 
| Assess pain | Pain will be assessed using visual analog scale pain scores (VAS) from 0 to 100 (0 means no pain at all and 100 maximum pain) at each visit. | 6-8 weeks,3, 6 and 36 months post-surgery | 
| To report the incidence of complications and their treatment, particularly with respect to the need of further surgery | Safety data during patients 36 months follow up are defined such as: Infection Neurovascular injury Allergic reaction Bone ischemia Irritation feeling | During the whole study (up to 36 months)] | 
| Assess surgery characteristics | Surgery characteristics are: Rupture of cerclage during the surgery (at time of implantation) Number of wire cerclages used implant used for osteosynthesis (nail or plate) Using of screw fixation operative time | During surgery (at D0) | 
| Assess physicians satisfaction regarding the use of Sterile Self Locking Polymer Cerclage System | Physicians satisfaction regarding the use of Sterile Self Locking Polymer Cerclage System will be assessed on: Global satisfaction of the surgeon Ease of use Ancillaries (Cable Passer, Tensioner) : ease of use and lightweight Ease of tension control by the surgeon using tensioner Ease of tracking of the cerclage on radiography Resistance over time (at least until bone consolidation) Presentation (ease of unwinding, packaging) | During surgery (at D0) |