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NCT Number: NCT05087667

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

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.

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Key information

Conditions

Femoral Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique ESQUIROL SAINT HILAIRE, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantation of Ortholoop cerclage

Device

implantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention

Implantation of Cerclage used in current practice

Device

implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention

Primary outcomes

  1. 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

    Time frame: 6 months post-surgery

    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.

Secondary outcomes

  1. Assess consolidation rate during 6 months post surgery

    Time frame: 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

  2. Asses union time

    Time frame: 3, 6 and 36 months post-surgery

    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. Assess rupture and migration rate of the cerclage after surgery throughout the follow-up

    Time frame: 3, 6 and 36 months post-surgery

    Rupture and migration of the cerclage are confirmed on X Ray imaging.

  4. Assess pain

    Time frame: 6-8 weeks,3, 6 and 36 months post-surgery

    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.

  5. To report the incidence of complications and their treatment, particularly with respect to the need of further surgery

    Time frame: During the whole study (up to 36 months)]

    Safety data during patients 36 months follow up are defined such as:

    Infection Neurovascular injury Allergic reaction Bone ischemia Irritation feeling

  6. Assess surgery characteristics

    Time frame: During surgery (at D0)

    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

  7. Assess physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System

    Time frame: During surgery (at D0)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Saab, Dr

CONTACT

[email protected]

+33 (0) 1 47 08 63 41

Sponsors and collaborators

Lead sponsor

Quanta Medical

Industry

Collaborators

  • Cousin Biotech

Registry information

Official study 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.

Acronym: SERRE

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Oct 21, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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