- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05676567
Golf After Orthopaedic Surgery: A Longitudinal Follow-up (GOLF) Study
Aims The primary aim of this prospective, multi-centre study is to describe the rates of returning to golf following hip, knee and shoulder arthroplasty in an active golfing population. Secondary aims will include determining the timing of return to golf, changes in ability, handicap, and mobility, and assessing joint-specific and health-related outcomes following surgery.
Methods This is a multi-centre, prospective, longitudinal study between the Hospital for Special Surgery, New York City and Edinburgh Orthopaedics, Royal Infirmary of Edinburgh, United Kingdom. Both centres are high-volume arthroplasty centres, specialising in upper and lower limb arthroplasty. Patients undergoing hip, knee or shoulder arthroplasty at either centres, and who report being golfers prior to arthroplasty will be included. Patient-reported outcome measures will obtained at 6 weeks, 3 months, 6 months and 12 months. A one-year period of recruitment will be undertaken of arthroplasty patients at both sites.
Conclusions The results of this prospective study will provide clinicians with accurate data to deliver to patients with regards to the likelihood of return to golf and timing of when they can expect to return to golf following their hip, knee or shoulder arthroplasty, as well as their joint-specific functional outcomes. This will help patients to manage their postoperative expectations and plan their postoperative recovery pathway.
Study Overview
Status
Detailed Description
This study will include adult patients who participate in golf (>18 years) at the Trauma and Orthopaedic Surgery Department, The Royal Infirmary of Edinburgh;) undergoing joint arthroplasty. The study will commence once NHS research ethics committee (REC) approval and NHS R&D Management approval is granted at the Royal Infirmary of Edinburgh.
The treatment that patients receive will not be affected by involvement in the study. The only difference in the patient pathway will be additional phone call/online follow ups of golf-related outcome measures postoperatively.
All patients will be identified in the clinic or pre-assessment clinic by the surgical team (consultant or registrar) or research assistant and be given the patient information sheet at one of these visits. Patients undergoing joint replacement in the orthopaedic unit are already offered to consent to follow up in the arthroplasty database at the time of attending the pre-assessment clinic and therefore additional paperwork will be added to enrol in the proposed golf study.
Patients will have access to the consent form at either the clinic or pre-assessment clinic. They are routinely offered to consent for arthroplasty follow up via our database which is in the form of 6 and 12 month postal questionnaires. An additional consent form will be included if patients identify as golfers on the questionnaire at the time of consenting for routine their arthroplasty.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Midlothian
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Edinburgh, Midlothian, United Kingdom, EH16 4SA
- Recruiting
- Edinburgh Orthopaedics
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Contact:
- Nick Clement, FRCS (Orth), MD, PhD
- Phone Number: 01315361000
- Email: nickclement@doctors.org.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
1. Age ≥18 years 2. A self-reported golfer 3. Able to consent to treatment 4. Assessed and listed for one of the following surgical procedures
- Total hip arthroplasty
- Hip resurfacing
- Revision hip arthroplasty
- Total knee arthroplasty
- Unicompartmental knee arthroplasty
- Revision knee arthroplasty
- Total shoulder arthroplasty
- Reverse shoulder arthroplasty
- Shoulder resurfacing arthroplasty
- Revision shoulder arthroplasty
Exclusion Criteria:
- 1. Patients unable to comply with post-operative data gathering including completing questionnaires 2. Patients declining operative management 3. No desire to return to golf postoperatively 4. Medical co-morbidities that affect the patient's ability to play golf, that will ultimately not allow the patient to return to golf postoperatively
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Hip Arthroplasty
Patients undergoing total hip replacement, hip resurfacing or revision hip replacement
|
Knee Arthroplasty
Patients undergoing total knee replacement, partial knee replacement or revision knee replacement
|
Shoulder Arthroplasty
Patients undergoing total shoulder replacement, reverse shoulder replacement or partial shoulder replacement (hemiarthroplasty).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate and timing of returning to golf following hip, knee and shoulder arthroplasty
Time Frame: 1 year
|
The primary outcome will be to report the rates of return to golf following hip, knee and shoulder arthroplasty.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Golf related outcomes
Time Frame: 1 year
|
Secondary outcomes will include the timing of return, changes in the frequency of golfing, changes in mobility on the golf course, changes in handicap, joint pain during and after golf, and satisfaction with their involvement in golf.
|
1 year
|
Patient-reported outcome measure 1
Time Frame: 1 year
|
Golf After Arthroplasty Surgery Score
|
1 year
|
Patient-reported outcome measure 2
Time Frame: 1 year
|
Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS-JR)
|
1 year
|
Patient-reported outcome measure 3
Time Frame: 1 year
|
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
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1 year
|
Patient-reported outcome measure 4
Time Frame: 1 year
|
American Shoulder and Elbow Score (ASES)
|
1 year
|
Patient-reported outcome measure 5
Time Frame: 1 year
|
PROMIS Global Health Survey
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 305142
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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