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

Primary Purpose

Hip Osteoarthritis, Post-traumatic Osteoarthritis, Inflammatory Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Manual Total Hip Replacement
Robot-Assisted Total Hip Replacement
Sponsored by
The Royal Orthopaedic Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip replacement, THR, Robotic, Arthroplasty, Hip Surgery, Range of Motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Royal Orthopaedic Hospital NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual Total Hip Replacement

Robot-Assisted Total Hip Replacement

Arm Description

Manual Total Hip Replacement

Robot-Assisted Total Hip Replacement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Using the Oxford Hip score to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
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
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
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
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 .

Full Information

First Posted
June 27, 2022
Last Updated
September 7, 2023
Sponsor
The Royal Orthopaedic Hospital NHS Trust
Collaborators
Stryker Nordic
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1. Study Identification

Unique Protocol Identification Number
NCT05507073
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Orthopaedic Hospital NHS Trust
Collaborators
Stryker Nordic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Individual/s carrying out assessment post-intervention are not aware of the intervention allocation
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Total Hip Replacement
Arm Type
Active Comparator
Arm Description
Manual Total Hip Replacement
Arm Title
Robot-Assisted Total Hip Replacement
Arm Type
Experimental
Arm Description
Robot-Assisted Total Hip Replacement
Intervention Type
Procedure
Intervention Name(s)
Manual Total Hip Replacement
Other Intervention Name(s)
Hip Arthroplasty, Hip Replacement, Total Hip Replacement
Intervention Description
Implantation of a hip Device to alleviate pain and recover range of movement
Intervention Type
Procedure
Intervention Name(s)
Robot-Assisted Total Hip Replacement
Other Intervention Name(s)
Hip replacement, Robotic Hip replacement, Robot Assisted Hip Arthroplasty
Intervention Description
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement
Primary Outcome Measure Information:
Title
Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
Description
To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR
Time Frame
6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures
Description
To determine whether the Robotic THR improves patient reported outcome measures
Time Frame
12 months
Title
Using the Oxford Hip score to determine improvement in Patient reported outcome measures
Description
To determine whether the Robotic THR improves patient reported outcome measures
Time Frame
12 months
Title
Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures
Description
To determine whether the Robotic THR improves patient reported outcome measures
Time Frame
12 months
Title
Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.
Description
To determine whether Robotic Surgery reduces leg length Discrepancy compared to manual THR
Time Frame
12 months
Title
Measure the duration of surgery and compare the duration of robotic THR to manual THR
Description
To determine whether the Robotic THR increases operation duration compared to Manual surgery
Time Frame
During Surgery
Title
Measure and compare the length of stay between Robotic and Manual THR surgeries
Description
To determine if length of hospital stay is reduced after robotic THR .
Time Frame
During length of stay in hospital average 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward T Davis, MD
Phone
01216854000
Ext
55306
Email
edward.davis@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sam C Papadopoullos, BSc
Phone
01216854000
Ext
55306
Email
sam.papadopoullos@nhs.net
Facility Information:
Facility Name
The Royal Orthopaedic Hospital NHS Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth Stephens
Phone
01216854120
Email
gareth.stephens@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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