Knee Osteoarthritis Risk in Retired Professional Footballers

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02098044
• Other study ID #: 13130
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1300
• Est. completion date: December 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United Kingdom	Academic Rheumatology	Nottingham	Nottinghamshire

Sponsors (6)

Lead Sponsor	Collaborator
University of Nottingham	Arthritis Research UK, Federation Internationale de Football Association (FIFA), Football Association (UK), Professional Football Association (UK), SPIRE Hospitals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Drawer S, Fuller CW. Evaluating the level of injury in English professional football using a risk based assessment process. Br J Sports Med. 2002 Dec;36(6):446-51. — View Citation

Zhang W, McWilliams DF, Ingham SL, Doherty SA, Muthuri S, Muir KR, Doherty M. Nottingham knee osteoarthritis risk prediction models. Ann Rheum Dis. 2011 Sep;70(9):1599-604. doi: 10.1136/ard.2011.149807. Epub 2011 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Reported Knee Pain	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	Radiographic Knee OA changes	Bilateral x rays using standardised rigs for 2 views. Postero-anterior view (30 degrees flexion, weight bearing) and skyline views.	up to 12 months

External Links

•   Arthritis Research UK OA and Football Study