Osteoarthritis of the KneeNCT02098044
Knee Osteoarthritis Risk in Retired Professional Footballers
An observational study of Osteoarthritis of the Knee, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- How many people
- 1,300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Phase III
- Aged 39 and under
- Comorbidities such as rheumatoid arthritis, gout, osteoporosis
- History of injury, trauma or surgery to the lower limb.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Rheumatology
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Keywords
- knee osteoarthritis, epidemiology, risk factors, prevalence, professional football
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Professional footballers | Retired professional footballers | |
| Control Population | members of the general public recruited from the east midlands region |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (1)
Radiographic Knee OA changes
Bilateral x rays using standardised rigs for 2 views. Postero-anterior view (30 degrees flexion, weight bearing) and skyline views.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK, Federation Internationale de Football Association, SPIRE Hospitals, Football Association (UK), Professional Football Association (UK)
- Responsible party
- Sponsor
- Investigators
- Michael Doherty, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098044
- Sponsor's protocol ID
- 13130
- Status last verified
- May 2018
- First submitted
- 14 Mar 2014
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12453840Zhang 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.
PubMed 21613308Fernandes 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.
PubMed 31501119
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Prevalence of Knee Osteoarthritis and Pain in Retired Professional Male Footballers in the United Kingdom
- ClinicalTrials.gov ID
- NCT02098044
- Acronym / sponsor ID
- 13130
- Conditions
- Osteoarthritis of the Knee
- Keywords
- knee osteoarthritis, epidemiology, risk factors, prevalence, professional football
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Arthritis Research UK, Federation Internationale de Football Association, SPIRE Hospitals, Football Association (UK), Professional Football Association (UK)
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professional footballers | – | –Retired professional footballers |
| Control Population | – | –members of the general public recruited from the east midlands region |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Radiographic Knee OA changes
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Background: PubMed 12453840Drawer 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.
- Background: PubMed 21613308Zhang 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.
- Derived from this study: PubMed 31501119Fernandes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Doherty, MD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Knee, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Reported Knee Pain (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098044, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.