NCT02154516已完成不适用
A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of Participants With Device-Related Revisions
研究概览
简要总结
The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years old
- •Skeletally mature
- •Requires primary, unilateral total hip arthroplasty due to degenerative join disease
- •Preoperative Harris Hip Score of less than or equal to 70
- •Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
- •Given consent to participate in the study
- •Able to understand the purpose of the study, his/her role, and is available for follow-up
- •10 year extension:
- •Subject has completed the 2 year primary study
- •Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
- •Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up
排除标准
- •Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
- •Requires bilateral THA
- •Requires revision of a prior hip replacement
- •Active infection or sepsis
- •History of local hip infection
- •Known metastatic or neoplastic disease
- •Conditions that may interfere with THA survival or outcomes
- •Need for structural bone grafts to support the implant
- •Contralateral lower extremity condition
- •Has other joint replacements or plans for other joint replacements within 2 years
- •Systemic steroid therapy within 3 months prior to surgery
- •Life expectancy less than 2 years
- •Intra-articular therapy within 6 months of enrollment
- •Female of child-bearing age not using contraception
- •Inadequate bone stock to support the device
- •Moderate to severe renal insufficiency
- •Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
- •Above the knee amputation of the contralateral or ipsilateral leg
- •Known allergies to the components of the devices
- •Entered into another investigational study
- •Is a prisoner
- •10 year extension:
- •In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.
研究组 & 干预措施
Control Total Hip Replacement Device
Active Comparator
Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
- R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
- OXINIUM heads on polyethylene liners or
- Ceramic heads on ceramic liners (all uncemented components)
干预措施: ODH Hip System (Device)
Investigational Hard-on-Hard Total Hip Replacement Device
Experimental
Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
- R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
- R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
- R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
- Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
干预措施: ODH Hip System (Device)
结局指标
主要结局
Number of Participants With Device-Related Revisions
时间窗: Postoperatively through 10 years
Device related revisions reported by the number of participants with a revision required (Yes/No).
Metal Ion Concentration in Whole Blood
时间窗: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.
次要结局
- Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only(Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.)
- Hip Disability and Osteoarthritis Outcome Scores (HOOS)(Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years)
- Radiographic Measures: Radiolucencies(3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative)
- Radiographic Measures: Heterotopic Ossification(3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative)
- Radiographic Measures: Subsidence(3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative)
- Health Economic Outcomes: Surgical Blood Loss(Intra-operative, up to 50 minutes)
- Health Economic Outcomes: Length of Hospital Stay(Hospital admission to discharge)
- Health Economic Outcomes: Operative Time(Intra-operative)
- Health Economic Outcomes: Re-Hospitalizations(Up to 10 years)
研究者
研究点 (2)
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