NCT01921309Unknown不适用
Phase 3 Randomized Controlled Study to Demonstrate Safety and Effectiveness of the BIOLOX Delta CoC THR System
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Corin
- 入组人数
- 342
- 试验地点
- 20
- 主要终点
- Composite Clinical Success
研究概览
简要总结
To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.
详细描述
The clinical research results for the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System will be compared to the control device
Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preoperative Harris Hip Score of ≤
- •preoperative Harris Hip Total Pain score of at least moderate.
- •diagnosed with non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental hip dysplasia (DDH) and congenital hip dysplasia (CDH).
- •pain rating of none or slight and are at least 12 months post-operative in the contralateral hip, if applicable.
- •have sufficient femoral and acetabular bone stock as determined by a clinician, and are suitable to receive implants as confirmed by x-rays.
排除标准
- •have a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms as determined by the clinician /investigator.
- •have a neurological disorders which may interfere or adversely affect gait, balance, or weight bearing (e.g. muscular dystrophy, multiple sclerosis).
- •diagnosed with metabolic disorders (e.g. osteomalacia), which may impair bone metabolism.
- •diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
- •immunologically suppressed.
- •receiving systemic steroid therapy, excluding inhalers, within 3 months prior to surgery.
- •diagnosed Charcot's disease, metastatic or neoplastic disease.
- •evidence of active infections that may spread to other areas of the body (e.g. osteomyelitis, pyogenic infection of the hip joint, overt infection, untreated urinary tract infection, etc.).
- •presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
- •previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
- •diagnosed with systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis or other diagnoses with autoimmune etiology.
- •diagnosed with osteoporosis or as evidenced on a DEXA scan for males over 75 or females over 65 years of age (within the last 12 months).
- •require structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
- •have acute femoral neck fracture or hip fractures.
- •have an above the knee amputation of the contralateral and/or ipsilateral leg.
- •have an existing total hip arthroplasty in the contralateral hip with a pain rating of 3 or more on a scale of 0 to 10, where 0 is "no pain" and 10 is "severe pain".
- •have had a total hip arthroplasty in the contralateral hip within the past 12 months.
- •have previously received a metal-on-metal hip arthroplasty.
- •have a highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis, etc.).
- •have any known sensitivity to device material.
- •Females who are pregnant.
- •Patients who are prisoners.
结局指标
主要结局
Composite Clinical Success
时间窗: 24 months post-operative
* HHS ≥ 80 at Month 24 (good/excellent) * No serious, definitely device related complications with onset on or prior to Month 24 * No radiographic failure at Month 24 * No removal, replacement, or modification of any component on or prior to Month 24.
次要结局
- HHS(24 months post-operative)
- HOOS score(24 months)
- Subjective pain(24 months)
- survival(24 months)
- adverse events(24 months)
研究者
研究点 (20)
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