Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
NCT ID: NCT05087667
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
202 participants
INTERVENTIONAL
2022-03-08
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polymer Cerclage System OrthoLoop
Patients receives Ortholoop Cerclage System
Implantation of Ortholoop cerclage
implantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention
cerclages used in standard care
Patients receives cerclages used in standard care"
Implantation of Cerclage used in current practice
implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention
Interventions
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Implantation of Ortholoop cerclage
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
implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cousin Biotech
INDUSTRY
Quanta Medical
INDUSTRY
Responsible Party
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Locations
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Clinique ESQUIROL SAINT HILAIRE
Agen, France, France
Hôpital Privé Francheville
Périgueux, France, France
CH Tourcoing
Tourcoing, France, France
CHU Lille
Lille, Nord, France
CH Agen
Agen, , France
CH Arcachon
Arcachon, , France
Clinique de Saint Omer
Blendecques, , France
CH Le Mans
Le Mans, , France
CH Libourne
Libourne, , France
Ch Metz - Thionville
Metz, , France
CHRU Nancy
Nancy, , France
CHU Nimes
Nîmes, , France
Polyclinique Du Parc
Saint-Saulve, , France
CHU Toulouse
Toulouse, , France
CH Valenciennes
Valenciennes, , France
Countries
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Central Contacts
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Facility Contacts
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Damien LAQUES, Dr
Role: primary
Guy AMSALLEM, Dr
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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3069_CERCPMCF
Identifier Type: -
Identifier Source: org_study_id
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