A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Oxford Hip Score (OHS)
研究概览
简要总结
The purpose of ReHip2 is to explore the impact on function and quality of life in patients following Total Hip Replacement (THR). A randomised controlled trial will compare two different rehabilitation pathways following surgery (Routine care with precautions and Treatment group with no precautions). The proposal is to carry out the RCT with a minimum of 182 patients based in the UK.
详细描述
Dislocation of the hip following total hip replacement (THR) is the sole reason for the endorsement of precautions following THR. This has remained unchanged sine the first hip replacement in 1969.
The precautions are;
- Patients must not bend past 90 degrees at the hip (including sitting)
- Patients must not twist in either standing or sitting
- Patients must partial weight bear with elbow crutches for a minimum of 6 weeks
- Patients must sleep on their back for a minimum of 6 weeks
- Patients must not cross their legs
Studies exploring factors affecting dislocation following THR identified three main influences: surgical technique, type of prosthesis and post-operative precautions. A number of studies have challenged the continued use of precautions or explored their impact on dislocation. However, these studies did not fully consider the impact of all precautions on dislocation, choosing to only select elements of the precautions for investigation. A recent review concluded the evidence evaluating practice and the impact of precautions was of poor quality. The review suggested further research should take into account different surgical approaches, different femoral head sizes and the type of prosthesis. Although there are studies that explored some of these hip dislocation confounders, the true impact of precautions remains unknown.
Whilst precautions continue to be endorsed by surgeons and other clinicians, previous challenges have raised awareness of the possible excessiveness of precautions and the importance of further robust work recommended. This is particularly so in the wake of developments in surgical technique and prostheses design, such as hip joint capsule repair and larger femoral head sizes (larger hip replacements). These developments and their impact on dislocation are beginning to cast doubt on the impact of post-operative precautions and their direct link to incidence of dislocation, which is their primary purpose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants over the age of 18 years will be included.
- •All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis
- •The patients operating consultant agreed to involvement of their patients in the study.
- •All subjects assessed during routine pre-operative assessment in their respective hospital will have been assigned an American Society of Anesthesiologists (ASA) up to grade 3 out of a total of 6 (defined as 'severe systemic disease that limits activity but is not incapacitating').
- •Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.
- •All surgical approaches (anterior, lateral and posterior), cemented and un-cemented prostheses and all size femoral head size.
排除标准
- •The operating consultant declined participation in the study.
- •The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.
- •ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'
- •Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)
- •Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)
- •Patients unable to complete the postal outcome measures.
- •Any patient with pre-operative cognitive impairment (Dementia or Learning disabilities).
- •Patients undergoing THR for treatment of fractured neck of femur.
结局指标
主要结局
Oxford Hip Score (OHS)
时间窗: assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Consists of 12 items measuring pain, activity, joint mobility and ambulatory activity using a 5 point ordinal Likert Scale over the previous 4 weeks. The total score for the OHS range from 12-60 with the lowest score of 12 signifying the least limited function and the highest score of 60 signifying the most limited function.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery)
- EQ-5D-L(assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery)
研究者
Justine Theaker
Principal Investigator
University of Manchester