Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Implantation of a hip Device to alleviate pain and recover range of movement
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement
The Royal Orthopaedic Hospital NHS Trust
Birmingham, United Kingdom
RECRUITINGImpingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR
Time frame: 6 weeks post-intervention
Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
Time frame: 12 months
Using the Oxford Hip score to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
Time frame: 12 months
Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
Time frame: 12 months
Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.
To determine whether Robotic Surgery reduces leg length Discrepancy compared to manual THR
Time frame: 12 months
Measure the duration of surgery and compare the duration of robotic THR to manual THR
To determine whether the Robotic THR increases operation duration compared to Manual surgery
Time frame: During Surgery
Measure and compare the length of stay between Robotic and Manual THR surgeries
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To determine if length of hospital stay is reduced after robotic THR .
Time frame: During length of stay in hospital average 3 days