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

NCT05087667 | Recruiting

• 1 other identifier: 3069_CERCPMCF
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 15

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.

Conditions

Femoral Fracture

Outcome Measures

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

  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 Outcomes (7)

• Assess consolidation rate during 6 months post surgery

  6 months post-surgery

• Asses union time

  3, 6 and 36 months post-surgery

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

  3, 6 and 36 months post-surgery

• Assess pain

  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

  During the whole study (up to 36 months)]

Study Arms (2)

Polymer Cerclage System OrthoLoop

EXPERIMENTAL

Patients receives Ortholoop Cerclage System

Device: Implantation of Ortholoop cerclage

cerclages used in standard care

ACTIVE COMPARATOR

Patients receives cerclages used in standard care"

Device: Implantation of Cerclage used in current practice

Interventions

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

Polymer Cerclage System OrthoLoop

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

cerclages used in standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Quanta Medical: lead
• Cousin Biotech: collaborator

Study Sites (15)

Clinique ESQUIROL SAINT HILAIRE

Agen, France, 47000, France

RECRUITING

Hôpital Privé Francheville

Périgueux, France, 24000, France

NOT YET RECRUITING

CH Tourcoing

Tourcoing, France, 59208, France

ACTIVE NOT RECRUITING

CHU Lille

Lille, Nord, 59000, France

RECRUITING

CH Agen

Agen, 47000, France

RECRUITING

CH Arcachon

Arcachon, 33164, France

ACTIVE NOT RECRUITING

Clinique de Saint Omer

Blendecques, 62575, France

RECRUITING

CH Le Mans

Le Mans, 72037, France

RECRUITING

CH Libourne

Libourne, 33505, France

RECRUITING

Ch Metz - Thionville

Metz, 57085, France

RECRUITING

CHRU Nancy

Nancy, 54000, France

RECRUITING

CHU Nimes

Nîmes, 30900, France

TERMINATED

Polyclinique Du Parc

Saint-Saulve, 59880, France

RECRUITING

CHU Toulouse

Toulouse, 31300, France

TERMINATED

CH Valenciennes

Valenciennes, 59300, France

RECRUITING

Related Publications (11)

• Lindahl H. Epidemiology of periprosthetic femur fracture around a total hip arthroplasty. Injury. 2007 Jun;38(6):651-4. doi: 10.1016/j.injury.2007.02.048. Epub 2007 May 2.

  PMID: 17477925 BACKGROUND

• Rayan F, Haddad F. Periprosthetic femoral fractures in total hip arthroplasty - a review. Hip Int. 2010 Oct-Dec;20(4):418-26. doi: 10.1177/112070001002000402.

  PMID: 21157744 BACKGROUND

• Tsiridis E, Pavlou G, Venkatesh R, Bobak P, Gie G. Periprosthetic femoral fractures around hip arthroplasty: current concepts in their management. Hip Int. 2009 Apr-Jun;19(2):75-86. doi: 10.1177/112070000901900201.

  PMID: 19462362 BACKGROUND

• Ferbert T, Jaber A, Gress N, Schmidmaier G, Gotterbarm T, Merle C. Impact of intraoperative femoral fractures in primary hip arthroplasty: a comparative study with a mid-term follow-up. Hip Int. 2020 Sep;30(5):544-551. doi: 10.1177/1120700019849911. Epub 2019 May 17.

  PMID: 31096789 BACKGROUND

• Ebraheim NA, Sochacki KR, Liu X, Hirschfeld AG, Liu J. Locking plate fixation of periprosthetic femur fractures with and without cerclage wires. Orthop Surg. 2013 Aug;5(3):183-7. doi: 10.1111/os.12052.

  PMID: 24002835 BACKGROUND

• Angelini A, Battiato C. Combination of low-contact cerclage wiring and osteosynthesis in the treatment of femoral fractures. Eur J Orthop Surg Traumatol. 2016 May;26(4):397-406. doi: 10.1007/s00590-016-1761-3. Epub 2016 Mar 17.

  PMID: 26983607 BACKGROUND

• Gordon K, Winkler M, Hofstadter T, Dorn U, Augat P. Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation - a biomechanical study. Injury. 2016 Jun;47 Suppl 2:S51-7. doi: 10.1016/S0020-1383(16)47009-9.

  PMID: 27338228 BACKGROUND

• Angelini A, Battiato C. Past and present of the use of cerclage wires in orthopedics. Eur J Orthop Surg Traumatol. 2015 May;25(4):623-35. doi: 10.1007/s00590-014-1520-2. Epub 2014 Sep 4.

  PMID: 25186972 BACKGROUND

• Altenburg AJ, Callaghan JJ, Yehyawi TM, Pedersen DR, Liu SS, Leinen JA, Dahl KA, Goetz DD, Brown TD, Johnston RC. Cemented total hip replacement cable debris and acetabular construct durability. J Bone Joint Surg Am. 2009 Jul;91(7):1664-70. doi: 10.2106/JBJS.G.00428.

  PMID: 19571089 BACKGROUND

• Silverton CD, Jacobs JJ, Rosenberg AG, Kull L, Conley A, Galante JO. Complications of a cable grip system. J Arthroplasty. 1996 Jun;11(4):400-4. doi: 10.1016/s0883-5403(96)80029-5.

  PMID: 8792246 BACKGROUND

• 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.

  PMID: 31326103 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Marc Saab, Dr

CONTACT

+33 (0) 1 47 08 63 41; b.hill@quanta-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded study. The patient will be blinded from the randomization arm. As the procedure is performed under general anaesthesia, the patient will not be informed whether or not the Sterile Self Locking Polymer Cerclage System has been implanted as a result of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cluster's randomization

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 21, 2021
• Study Start: March 8, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)