Clinical trial NCT05507073: A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
Official title: A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Post-traumatic Osteoarthritis
Inflammatory Arthritis
Congenital Hip Problems
Avascular Necrosis of Hip
Keywords: hip replacement
THR
Robotic
Arthroplasty
Hip Surgery
Range of Motion
Lead sponsor: The Royal Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2022-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
timeFrame: 6 weeks post-intervention
Secondary outcomes:
measure: Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures
timeFrame: 12 months
measure: Using the Oxford Hip score to determine improvement in Patient reported outcome measures
timeFrame: 12 months
measure: Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures
timeFrame: 12 months
measure: Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.
timeFrame: 12 months
measure: Measure the duration of surgery and compare the duration of robotic THR to manual THR
timeFrame: During Surgery
measure: Measure and compare the length of stay between Robotic and Manual THR surgeries
timeFrame: During length of stay in hospital average 3 days
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital NHS Trust
Study officials:
References: