Which patient with an anterior cruciate ligament rupture will need a surgical reconstruction?*
Recruiting
- Conditions
- anterior cruciate ligament rupturetear10043237
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: aged 18 year or older, with a complete primary ACL
rupture (confirmed by MRI and physical examination), maximum of 6 weeks of
physical therapy, and willing to comply with the study protocol.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: multi ligament trauma indicated for surgical
intervention, presence of another disorder that affects the activity level of
the lower limb, pregnancy, and insufficient command of the Dutch language.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Recovery of physical functioning during 2 years assessed by the IKDC<br /><br>questionnaire. Besides, differences in medical consumption, absence from work<br /><br>or decreased productivity, and patient costs, will be assessed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Return to sport activity and level of sport activity: Tegner score.<br /><br>- Knee pain: number rating scale (NRS)<br /><br>- Knee specific outcome score (Knee Injury and Osteoarthritis Outcome Score<br /><br>(KOOS))<br /><br>- Satisfaction with treatment<br /><br>- Kinesiophobia: Tampa scale<br /><br>- General quality of life: EQ-5D-5L<br /><br>- total costs: intramural and extramural medical costs (iMCQ) and productivity<br /><br>loss (iPCQ);<br /><br>- adverse events<br /><br>- physical examination, stability tests of the knee: Lachman, anterior drawer<br /><br>and pivot shift tests</p><br>