Comparing manual and robotic hip replacement surgeries
A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
NA · The Royal Orthopaedic Hospital NHS Trust · NCT05507073
This study is testing whether robotic hip replacement surgery works better than traditional manual surgery for people with hip problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Royal Orthopaedic Hospital NHS Trust (other) |
| Locations | 1 site (Birmingham) |
| Trial ID | NCT05507073 on ClinicalTrials.gov |
What this trial studies
This study is a single-blinded randomized controlled trial that compares the outcomes of manual total hip replacement (THR) with robotic-assisted THR in patients diagnosed with various hip conditions. A total of 50 participants will be randomly assigned to receive either manual or robotic THR, with assessments conducted before and after the surgery. The study aims to evaluate the range of motion and potential impingement using CT scans post-operatively. Participants will undergo standard rehabilitation and follow-up visits at 6 weeks and 12 months after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with hip osteoarthritis or related conditions who are scheduled for total hip replacement.
Not a fit: Patients with significant co-morbidities or previous surgeries on the same hip may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical approach offers better outcomes for patients undergoing hip replacement.
How similar studies have performed: Previous studies have shown promising results with robotic-assisted surgeries, suggesting potential advantages over manual techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham
- The Royal Orthopaedic Hospital NHS Trust — Birmingham, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Edward T Davis, MD
- Email: edward.davis@nhs.net
- Phone: 01216854000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Osteoarthritis, Post-traumatic Osteoarthritis, Inflammatory Arthritis, Congenital Hip Problems, Avascular Necrosis of Hip, hip replacement, THR, Robotic