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

NCT05507073 | Unknown

• 1 other identifier: ROH20ORTH16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Impingement 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

  6 weeks post-intervention

Secondary Outcomes (6)

• Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures

  12 months

• Using the Oxford Hip score to determine improvement in Patient reported outcome measures

  12 months

• Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures

  12 months

• Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.

  12 months

• Measure the duration of surgery and compare the duration of robotic THR to manual THR

  During Surgery

Study Arms (2)

Manual Total Hip Replacement

ACTIVE COMPARATOR

Manual Total Hip Replacement

Procedure: Manual Total Hip Replacement

Robot-Assisted Total Hip Replacement

EXPERIMENTAL

Robot-Assisted Total Hip Replacement

Procedure: Robot-Assisted Total Hip Replacement

Interventions

Manual Total Hip Replacement PROCEDURE

Implantation of a hip Device to alleviate pain and recover range of movement

Also known as: Hip Arthroplasty, Hip Replacement, Total Hip Replacement

Manual Total Hip Replacement

Robot-Assisted Total Hip Replacement PROCEDURE

Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement

Also known as: Hip replacement, Robotic Hip replacement, Robot Assisted Hip Arthroplasty

Robot-Assisted Total Hip Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Royal Orthopaedic Hospital NHS Trust: lead
• Stryker Nordic: collaborator

Study Sites (1)

The Royal Orthopaedic Hospital NHS Trust

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Edward T Davis, MD

CONTACT

01216854000; edward.davis@nhs.net

Sam C Papadopoullos, BSc

CONTACT

01216854000; sam.papadopoullos@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individual/s carrying out assessment post-intervention are not aware of the intervention allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: August 18, 2022
• Study Start: April 6, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)