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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 30
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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
时间窗: 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.
次要结局
- Asses union time(3, 6 and 36 months post-surgery)
- Assess surgery characteristics(During surgery (at D0))
- Assess consolidation rate during 6 months post surgery(6 months post-surgery)
- Assess physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System(During surgery (at D0))
- 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)])