Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by Sodium Polystyrene Sulfonate -PolyNASS- (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
- 试验地点
- 14
- 主要终点
- Osseous-integration of the femoral stem and the acetabular component
研究概览
简要总结
The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment.
The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis.
Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis.
A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting.
No previous clinical trial
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 50 and under 75 years OR aged under 50 years with joint lesions not amenable to successful conservative treatment.
- •THA following a primary or secondary osteoarthritis
- •THA following an aseptic osteonecrosis
- •THA following a rapidly destructive osteoarthritis
- •Social insurance
- •Informed and signed consent
排除标准
- •Patients younger than 50 years and with joint lesions that can be successfully treated with conservative treatment
- •Inflammatory rheumatism
- •Long-term corticosteroid treatment
- •Tumor Pathology of the hip bone
- •Study femoral stem not adapted to the patient's anatomy (verified on preoperative X-rays using Ceraver templates).
- •Loss of bone of the joint that makes it impossible to properly anchor a cementless prosthesis
- •Acetabular or femoral bone graft associated
- •Infectious hip arthritis history
- •Evolving infection of the articulation or peri-articular region involved, including severe neuroarthropathy
- •Surgical history on the affected hip
- •Allergy known to any component of prostheses
- •Known hypersensitivity to polystyrene sulfonate resins
- •Native cotyl with a diameter of less than 42mm or greater than 68mm
- •Significant muscle loss, neuromuscular injury or vascular insufficiency of affected limb
- •Charcot's disease
- •Immunocompromised patients
- •Difficulties of follow-up (departure on vacation, imminent change, geographical distance, patients not residing in metropolis, insufficient motivation) or understanding of the protocol
- •Patient Refusal
- •Pregnant and lactating women
结局指标
主要结局
Osseous-integration of the femoral stem and the acetabular component
时间窗: 1 year post-surgery for both groups
(Yes/No). THA will be judged "osseointegrated" if the acetabulum AND the femur meet the following osseous-integration criteria: * femur: score of Engh and Massin strictly greater than 10 * AND acetabulum: Implant migration less than 5 mm AND no total radiolucent line and no osteocondensation at the bone-cup interface in the 3 zones of Gruen
次要结局
- Mid-term survival rate of the hip prosthesis(15 years post-surgery for CERAFIT group and 16 years post-surgery for ACTISURF group)
- Score ARA femur of Epinette(1 year post-surgery for both groups)
- Hip prosthesis infection rate defined according to the 2011 criteria of the Musculoskeletal Infection Society (MSIS). In case of suspicion of infection, a hip joint aspiration with synovial fluid culture will be performed.(2 years post-surgery for both groups)
- Postel Merle d'Aubigné (PMA) score(2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- Harris Hip Score (HHS)(2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- Forgotten Hip Score (FHS)(2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- Osseous-integration of the femoral stem and the acetabular component based on radiographies(2 years post-surgery for both groups. 5 and 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- THA survival(6 years post-surgery for ACTISURF group. 10 years post-surgery for both groups.)
- Adverse and serious adverse events evaluation(For ACTISURF group: at 4, 6, 8, 10, 12, 14, 16 years post-surgery. For CERAFIT group: at 5, 10, and 15 years post-surgery.)