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临床试验/NCT05676567
NCT05676567进行中(未招募)不适用

Golf After Orthopaedic Surgery: A Longitudinal Follow-up (GOLF) Study

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
124
试验地点
1
主要终点
Rate and timing of returning to golf following hip, knee and shoulder arthroplasty

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1. Age ≥18 years
  • •A self-reported golfer
  • •Able to consent to treatment
  • •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

排除标准

  • •1. Patients unable to comply with post-operative data gathering including completing questionnaires
  • •Patients declining operative management
  • •No desire to return to golf postoperatively
  • •Medical co-morbidities that affect the patient's ability to play golf, that will ultimately not allow the patient to return to golf postoperatively

研究组 & 干预措施

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).

结局指标

主要结局

Rate and timing of returning to golf following hip, knee and shoulder arthroplasty

时间窗: 1 year

The primary outcome will be to report the rates of return to golf following hip, knee and shoulder arthroplasty.

次要结局

  • Patient-reported outcome measure 1(1 year)
  • Patient-reported outcome measure 2(1 year)
  • Golf related outcomes(1 year)
  • Patient-reported outcome measure 5(1 year)
  • Patient-reported outcome measure 3(1 year)
  • Patient-reported outcome measure 4(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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