Clinical trial NCT05087667: Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Fracture
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: Cousin Biotech
First posted: 2021-10-21
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster's randomization
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Assess consolidation rate during 6 months post surgery
timeFrame: 6 months post-surgery
measure: Asses union time
timeFrame: 3, 6 and 36 months post-surgery
measure: Assess rupture and migration rate of the cerclage after surgery throughout the follow-up
timeFrame: 3, 6 and 36 months post-surgery
measure: Assess pain
timeFrame: 6-8 weeks,3, 6 and 36 months post-surgery
measure: To report the incidence of complications and their treatment, particularly with respect to the need of further surgery
timeFrame: During the whole study (up to 36 months)]
measure: Assess surgery characteristics
timeFrame: During surgery (at D0)
measure: Assess physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System
timeFrame: During surgery (at D0)
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
state: Nord
city: Agen
country: France
facility: CH Agen
city: Agen
country: France
facility: Clinique ESQUIROL SAINT HILAIRE
city: Arcachon
country: France
facility: CH Arcachon
city: Blendecques
country: France
facility: Clinique de Saint Omer
city: Le Mans
country: France
facility: CH Le Mans
city: Libourne
country: France
facility: CH Libourne
city: Metz
country: France
facility: Ch Metz - Thionville
city: Nancy
country: France
facility: CHRU Nancy
city: Nîmes
country: France
facility: CHU Nimes
city: Périgueux
country: France
facility: Hôpital Privé Francheville
city: Saint-Saulve
country: France
facility: Polyclinique Du Parc
city: Toulouse
country: France
facility: CHU Toulouse
city: Tourcoing
country: France
facility: CH Tourcoing
city: Valenciennes
country: France
facility: CH Valenciennes
Study officials:
References:
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citation: Peeters I, Depover A, Van Tongel A, De Wilde L. A review of metallic and non-metallic cerclage in orthopaedic surgery: Is there still a place for metallic cerclage? Injury. 2019 Oct;50(10):1627-1633. doi: 10.1016/j.injury.2019.06.034. Epub 2019 Jul 13.