A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement

The Royal Orthopaedic Hospital NHS Trust

Status: Enrolling

Conditions: Post-traumatic Osteoarthritis; Avascular Necrosis of Hip; Hip Osteoarthritis; Congenital Hip Problems; Inflammatory Arthritis

Treatments: Procedure: Manual Total Hip Replacement; Procedure: Robot-Assisted Total Hip Replacement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05507073

ROH20ORTH16

Details and patient eligibility

About

Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Manual Total Hip Replacement

Active Comparator group

Description:

Manual Total Hip Replacement

Treatment:

Procedure: Manual Total Hip Replacement

Robot-Assisted Total Hip Replacement

Experimental group

Description:

Robot-Assisted Total Hip Replacement

Treatment:

Procedure: Robot-Assisted Total Hip Replacement