NCT02098044

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

March 14, 2014

Last Update Submit

May 23, 2018

Conditions

Keywords

knee osteoarthritisepidemiologyrisk factorsprevalenceprofessional football

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Radiographic Knee OA changes

    up to 12 months

Study Arms (2)

Professional footballers

Retired professional footballers

Control Population

members of the general public recruited from the east midlands region

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

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

You may not qualify if:

  • 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
  • Not a registered professional footballer
  • No written informed consent to participate
  • Phase III
  • Aged 39 and under
  • Comorbidities such as rheumatoid arthritis, gout, osteoporosis
  • History of injury, trauma or surgery to the lower limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Rheumatology

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (3)

  • 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. doi: 10.1136/bjsm.36.6.446.

    PMID: 12453840BACKGROUND
  • 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.

    PMID: 21613308BACKGROUND
  • Fernandes GS, Parekh SM, Moses J, Fuller CW, Scammell B, Batt ME, Zhang W, Doherty M. Depressive symptoms and the general health of retired professional footballers compared with the general population in the UK: a case-control study. BMJ Open. 2019 Sep 8;9(9):e030056. doi: 10.1136/bmjopen-2019-030056.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Doherty, MD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 27, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2018

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations