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

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

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Osteoarthritis; Inflammatory Arthritis; Hip Osteoarthritis; Avascular Necrosis of Hip; Congenital Hip Problems
• Intervention / Treatment: Procedure: Manual Total Hip Replacement; Procedure: Robot-Assisted Total Hip Replacement

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward T Davis, MD; Phone Number: 55306 01216854000; Email: edward.davis@nhs.net
• Study Contact Backup: Name: Sam C Papadopoullos, BSc; Phone Number: 55306 01216854000; Email: sam.papadopoullos@nhs.net

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • The Royal Orthopaedic Hospital NHS Trust
    • Contact: Gareth Stephens; Phone Number: 01216854120; Email: gareth.stephens@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual Total Hip Replacement	Procedure: Manual Total Hip Replacement; Implantation of a hip Device to alleviate pain and recover range of movement; Other Names: Total Hip Replacement; Hip Arthroplasty; Hip Replacement
Experimental: Robot-Assisted Total Hip Replacement	Procedure: Robot-Assisted Total Hip Replacement; Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement; Other Names: Hip replacement; Robotic Hip replacement; Robot Assisted Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures	To determine whether the Robotic THR improves patient reported outcome measures	12 months
Using the Oxford Hip score to determine improvement in Patient reported outcome measures	To determine whether the Robotic THR improves patient reported outcome measures	12 months
Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures	To determine whether the Robotic THR improves 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.	To determine whether Robotic Surgery reduces leg length Discrepancy compared to manual THR	12 months
Measure the duration of surgery and compare the duration of robotic THR to manual THR	To determine whether the Robotic THR increases operation duration compared to Manual surgery	During Surgery
Measure and compare the length of stay between Robotic and Manual THR surgeries	To determine if length of hospital stay is reduced after robotic THR .	During length of stay in hospital average 3 days

Collaborators and Investigators

• Sponsor: The Royal Orthopaedic Hospital NHS Trust
• Collaborators: Stryker Nordic

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Arthroplasty; Robotic; hip replacement; Range of Motion; THR; Hip Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis; Osteoarthritis, Hip
• Other Study ID Numbers: ROH20ORTH16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No