Knee Osteoarthritis Risk in Retired Professional Footballers

May 23, 2018 updated by: University of Nottingham

An Investigation of the Prevalence of Knee Osteoarthritis and Pain in Retired Professional Male Footballers in the United Kingdom

The OA and Football Study is an epidemiological study designed to establish the prevalence of knee osteoarthritis in retired professional footballers. The study will also identify the key risk factors associated with knee osteoarthritis. The study is comprised of three phases: Phase I involves the dissemination of a questionnaire (demographic details, players history, injury and surgery and other known risk factors of OA), Phase II is a radiographic study that involves x-rays in a sample of footballers both with and without knee pain and Phase III is a case control study which will compared retired professional footballers with age-matched controls recruited from the general population in the East Midlands region.

Study Overview

Status

Unknown

Conditions

Detailed Description

Number of Participants:

Phase I: 1000 Phase II: 855 Phase III: 500

Primary outcome: The questionnaire will contain player specific information and will include validated outcome measures such as the health status questionnaire as well as self-reported pain, recall of injury and surgery history. The results of the questionnaire will be exported firstly to Excel and subsequently, into MS Access as part of a managed database.

Study Type

Observational

Enrollment (Actual)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Academic Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Retired footballers will be recruited from a database of retired professional footballers. (cases)

The members of the general public will be recruited from the general population in the East Midlands region. (controls)

Description

Phase I

Inclusion Criteria:

• All current or retired professional male footballers (Registered with the Professional Footballer Association (age range 40 -80)

Phase II

Inclusion Criteria:

  • Professional footballers both with and without a history of knee pain knee OA or knee surgical history
  • No contraindications of the affected joint such as gout or rheumatoid arthritis
  • Willingness to participate in a clinical assessment of the knee and provision of blood samples.

Phase III

Inclusion Criteria for controls:

  • Over the age of 40 (age range 40 - 80)
  • Both with and without a history of knee pain over at least the last 1 year
  • No history of significant trauma, injury or surgery to the lower limb
  • American College of Rheumatology (ACR) classification of OA based on physical examination and clinical presentation: Pain in the knee and three of the following; over the age of 50, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement and no palpable warmth of synovium.

Phase I

Exclusion Criteria:

  • Not a registered professional footballer (current or past)
  • Inaccurate information (discrepancy with questionnaire information compared to other football records. This will be verified by the co-investigator, Dr Fernandes and Mr Sanjay Parekh)
  • Incomplete questionnaire or duplicate questionnaire.

Phase II

Exclusion Criteria:

  • Not a registered professional footballer
  • No written informed consent to participate

Phase III

Exclusion Criteria:

  • Aged 39 and under
  • Comorbidities such as rheumatoid arthritis, gout, osteoporosis
  • History of injury, trauma or surgery to the lower limb.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Professional footballers
Retired professional footballers
Control Population
members of the general public recruited from the east midlands region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Reported Knee Pain
Time Frame: up to 12 months
Questionnaire data with regards to acute knee pain, type of pain, duration of pain and knee injury and knee surgery history.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Knee OA changes
Time Frame: up to 12 months
Bilateral x rays using standardised rigs for 2 views. Postero-anterior view (30 degrees flexion, weight bearing) and skyline views.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Federation Internationale de Football Association
Arthritis Research UK
SPIRE Hospitals
Football Association (UK)
Professional Football Association (UK)

Investigators

  • Principal Investigator: Michael Doherty, MD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13130

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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