Randomised, Prospective, Post-Market Surveillance Study Comparing the Outcomes of Minimally Invasive and Conventional Surgical Procedures in Subjects Requiring Primary Total Hip Arthroplasty for Osteoarthritis.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
研究概览
简要总结
The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to undergo surgery using the minimally invasive or conventional surgical technique and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments with a focus on short term rehabilitation.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) Male or female subjects, aged between 18 and 75 years inclusive.
- •ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- •iii) Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •iv) Subjects with a primary diagnosis of osteoarthritis.
- •v) Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.
排除标准
- •i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, or extend their time to discharge beyond that required for their hip replacement surgery.
- •ii) Women who are pregnant.
- •iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- •iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- •v) Subjects who are currently involved in any injury litigation claims.
- •vi) Subjects with a Body Mass Index (BMI) >
- •vii) Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.
- •viii) Subjects requiring a simultaneous bilateral total hip arthroplasty.
- •ix) Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty
结局指标
主要结局
Time taken (in seconds) for subjects to walk 10 metres on the second post-operative day.
时间窗: Second post-operative day
Level of assistance required to perform 3 functional tasks (supine to sit, sit to stand and bed to chair transfer)on the second post-operative day
时间窗: Second post-operative day
Number of hours post-operatively after which subjects are first able to mobilise with a frame or crutches
时间窗: First post-operative day
Amount of time (in seconds) for which subjects are able to stand on the operative leg on the second post-operative day.
时间窗: Second post-operative day
次要结局
- Haematological parameters assessed over a 56 hours post op(56 hours post-operatively)
- Pain levels and wound condition(Until discharge)
- Harris Hip score(6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery)
- Oxford Hip score(6 weeks, 6 months, 1 yr, 2 yrs, 5 yrs and 10 yrs post-surgery)
- Trendelenberg sign(Until discharge and at 6 weeks)
- Day of discharge(Until discharge)
- Activity levels over specified distances(Until discharge)
- Radiological analysis(6weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)