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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507073
• Other study ID #: ROH20ORTH16
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: The Royal Orthopaedic Hospital NHS Trust
• Contact: Edward T Davis, MD
• Phone: 01216854000
• Email: edward.davis[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis of Hip
• Hip Osteoarthritis
• Inflammatory Arthritis
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-traumatic Osteoarthritis

Intervention

Procedure:
• Manual Total Hip Replacement
Implantation of a hip Device to alleviate pain and recover range of movement
• Robot-Assisted Total Hip Replacement
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement

Locations

Country	Name	City	State
United Kingdom	The Royal Orthopaedic Hospital NHS Trust	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
The Royal Orthopaedic Hospital NHS Trust	Stryker Nordic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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