A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
研究概览
简要总结
Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.
详细描述
This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial.
Arm 1: Manual total hip replacement with conventional templating Arm 2: Robotic total hip replacement In the study 25 participants will receive manual THR with conventional templating; the other 25 will receive Robotic THR.
Following recruitment in outpatient clinics, participants will undergo baseline assessments, including imaging and clinical assessment. All participants will then undergo THR surgery, which will likely entail an inpatient hospital stay of 1-2 days. Post-operative rehabilitation will be in line with the normal standard care for all participants. Post-operatively participants will make two visits to clinic at 6 weeks and 12 months (standard of care).
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 (Outcomes Assessor)
盲法说明
Individual/s carrying out assessment post-intervention are not aware of the intervention allocation
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
- •Participant is willing and able to give informed consent for participation in the trial
- •Male or Female, aged 18 to 85 years at recruitment into trial
- •Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, , or congenital or developmental hip disease, avascular necrosis of the hip
- •Listed for total hip replacement
- •Suitable for Accolade 2 stem and Trident cup prostheses
- •Female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial
- •In the Investigator's opinion, is able and willing to comply with all trial requirements
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
排除标准
- •Inability to provide informed consent
- •Previous surgery to the ipsilateral hip and implantation of metalwork.
- •Significant co-morbidities that would make follow up difficult or uncomfortable
- •Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- •Pregnancy or intention to become pregnant within the trial period.
研究组 & 干预措施
Manual Total Hip Replacement
Manual Total Hip Replacement
干预措施: Manual Total Hip Replacement (Procedure)
Robot-Assisted Total Hip Replacement
Robot-Assisted Total Hip Replacement
干预措施: Robot-Assisted Total Hip Replacement (Procedure)
结局指标
主要结局
Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
时间窗: 6 weeks post-intervention
To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR
次要结局
- Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures(12 months)
- Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.(12 months)
- Measure the duration of surgery and compare the duration of robotic THR to manual THR(During Surgery)
- Measure and compare the length of stay between Robotic and Manual THR surgeries(During length of stay in hospital average 3 days)
- Using the Oxford Hip score to determine improvement in Patient reported outcome measures(12 months)
- Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures(12 months)