Avascular Necrosis of Hip, Congenital Hip Problems, Hip Osteoarthritis, Inflammatory Arthritis, Post-traumatic Osteoarthritis
Conditions
Keywords
hip replacement, THR, Robotic, Arthroplasty, Hip Surgery, Range of Motion
Brief summary
Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.
Detailed description
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).
Interventions
PROCEDUREManual Total Hip Replacement
Implantation of a hip Device to alleviate pain and recover range of movement
PROCEDURERobot-Assisted Total Hip Replacement
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement
Sponsors
Stryker Nordic
The Royal Orthopaedic Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Individual/s carrying out assessment post-intervention are not aware of the intervention allocation
Intervention model description
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. Any participant that withdraws from the study will be replaced.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR | 6 weeks post-intervention | To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Using the Oxford Hip score to determine improvement in Patient reported outcome measures | 12 months | To determine whether the Robotic THR improves patient reported outcome measures |
| Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures | 12 months | To determine whether the Robotic THR improves patient reported outcome measures |
| Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures | 12 months | To determine whether the Robotic THR improves patient reported outcome measures |
| Measure the duration of surgery and compare the duration of robotic THR to manual THR | During Surgery | To determine whether the Robotic THR increases operation duration compared to Manual surgery |
| Measure and compare the length of stay between Robotic and Manual THR surgeries | During length of stay in hospital average 3 days | To determine if length of hospital stay is reduced after robotic THR . |
| Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy. | 12 months | To determine whether Robotic Surgery reduces leg length Discrepancy compared to manual THR |
Countries
United Kingdom
Contacts
Primary ContactEdward T Davis, MD
Backup ContactSam C Papadopoullos, BSc
Outcome results
None listed