Viewing Study NCT05676567


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Study NCT ID: NCT05676567
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-02-12
First Post: 2022-12-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Golf After Orthopaedic Surgery: A Longitudinal Follow-up (GOLF) Study
Sponsor: University of Edinburgh
Organization:

Study Overview

Official Title: Golf After Orthopaedic Surgery: A Longitudinal Follow-up (GOLF) Study
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2025-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: