PRevention of knee Osteoarthritis in Overweight Females (PROOF); long-term follow-up

Completed

• Conditions: knee osteoarthritis; wear and tear; 10023213

• Registration Number: NL-OMON41125
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

1) Was participant in original trial. 2) Gave informed consent to be contacted for long-term follow-up at final measurements of the original trial.

Exclusion Criteria

No criteria excluding individuals who fulfill the inclusion criteria.
Subjects with contra-indications for MRI will only be excluded for MRI measurements and subjects with bi-lateral total knee replacement will only be excluded for MRI and radiography.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the incidence of clinical knee osteoarthritis<br /><br>according to the 'clinical and radiologic ACR-criteria'</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are:<br /><br>- incidence of radiologic knee osteoarthritis (K&L >= 2)<br /><br>- incidence of joint space narrowing (JSN >= 1.0 mm)<br /><br>- progression of MRI features of knee osteoarthritis (MOAKS features)<br /><br>- WOMAC pain<br /><br>- WOMAC function<br /><br>- Quality of life<br /><br>- degenerative biomarkers in blood/urine</p><br>