NCT01106560已完成不适用
A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach
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
- 50
- 试验地点
- 1
- 主要终点
- Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach
研究概览
简要总结
This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.
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
- None
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
- •Males and females aged 18-75 years at time of surgery.
- •Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip.
- •Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- •Patients who signed the study consent form prior to surgery.
排除标准
- •Pregnant women or women who plan to conceive in the future.
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- •Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement).
- •Those with co-existent ipsilateral knee disease or back problems
- •Muscle contracture around the hip joint
- •Individuals who have undergone organ transplant.
- •Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- •Individuals who have had a THR on the contra-lateral side within the 6 months.
- •Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) < 16 points.
- •Individuals requiring bilateral hip replacement.
- •Individuals whose body mass index (BMI; kg/m2) >
- •Individuals with active or suspected infection or sepsis.
- •Individuals with renal failure and/or renal insufficiency.
- •Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.
研究组 & 干预措施
Anterior Approach Group
Active Comparator
(AMIS)
干预措施: Minimally Invasive Anterior Approach (Procedure)
Posterior Approach Group
Active Comparator
(Posterior)
干预措施: Standard postero-lateral approach (Procedure)
结局指标
主要结局
Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach
时间窗: on average up to 6 weeks
次要结局
- MRI evaluation(preop-1y after surgery)
- Clinical assessment of patient using the Harris Hip Score(pre-op and 6 weeks, 6 months, 1 year after surgery)
- Assessment of gait kinematics(6 weeks, 12 weeks and 6 months)
- Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score(pre-op, 1 year post-op)
- Assessment of patient's level of activity using the UCLA score(pre-op and 6 weeks, 6 months, 1 year after surgery)
- Radiological evaluation to assess the fixation and stability of femoral and acetabular components(pre-op and 6 weeks, 6 months, 1 year after surgery)
- Strength Testing(6 weeks, 6 months and 1y after surgery)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCLLymphoma, Large B-Cell, DiffuseNCT06289959Second Affiliated Hospital of Soochow University30
招募中
不适用
Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLCNon Small Cell Lung CancerNCT03769129Second Affiliated Hospital of Guangzhou Medical University100
已完成
不适用
YAG Vitreolysis for FloatersFloatersWeiss RingPosterior Vitreous DetachmentNCT02897583Ophthalmic Consultants of Boston52
已完成
不适用
The Vertos MILD™ Preliminary Patient Evaluation StudyLumbar Spinal StenosisNCT00749073Vertos Medical, Inc.10
已完成
1 期
Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine AdhesionAsherman SyndromeNCT02726971Fu Xing Hospital, Capital Medical University141