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ClinicalTrials.gov ID

NCT05087667

Lead Sponsor

Quanta MedicalINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

202Estimated

Last Update Posted

Mar 20, 2025Actual

Start Date

Mar 8, 2022Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Dec 2028Estimated

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.

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.

• Femoral Fracture

• Implantation of Ortholoop cerclage
• Implantation of Cerclage used in current practice

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Quanta MedicalINDUSTRY

Collaborators

Cousin BiotechINDUSTRY

baciulescua@ch-agen-nerac.fr0623900370