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

Femoral Fracture Clinical Trial

— SERRE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05087667
• Other study ID #: 3069_CERCPMCF
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: October 2025

Study information

• Verified date: September 2022
• Source: Quanta Medical
• Contact: Marc Saab, Dr
• Phone: +33 (0) 1 47 08 63 41
• Email: b.hill[@]quanta-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: October 2025
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures

Intervention

Device:
• 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

Locations

Country	Name	City	State
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	CHU Lille	Lille	Nord
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

Sponsors (2)

Lead Sponsor	Collaborator
Quanta Medical	Cousin Biotech

Country where clinical trial is conducted

France, 

References & Publications (11)

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/J — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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 — View Citation

Gordon K, Winkler M, Hofstädter 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. — View Citation

Lindahl H. Epidemiology of periprosthetic femur fracture around a total hip arthroplasty. Injury. 2007 Jun;38(6):651-4. Epub 2007 May 2. Review. — View 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. Re — View Citation

Rayan F, Haddad F. Periprosthetic femoral fractures in total hip arthroplasty - a review. Hip Int. 2010 Oct-Dec;20(4):418-26. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess consolidation rate during 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	6 months post-surgery
Secondary	Asses union time	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, 6 and 36 months post-surgery
Secondary	Assess rupture and migration rate of the cerclage after surgery throughout the follow-up	Rupture and migration of the cerclage are confirmed on X Ray imaging.	3, 6 and 36 months post-surgery
Secondary	Assess pain	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.	6-8 weeks,3, 6 and 36 months post-surgery
Secondary	To report the incidence of complications and their treatment, particularly with respect to the need of further surgery	Safety data during patients 36 months follow up are defined such as: Infection Neurovascular injury Allergic reaction Bone ischemia Irritation feeling	During the whole study (up to 36 months)]
Secondary	Assess surgery characteristics	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	During surgery (at D0)
Secondary	Assess physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System	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)	During surgery (at D0)