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.
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
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
Parallel
Implantation of Ortholoop cerclage
Deviceimplantation 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
Deviceimplantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention
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.
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
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.
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.
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.
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Quanta Medical
Lead sponsor
Cousin Biotech
Collaborator
