Status:
COMPLETED
Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Federaal Kenniscentrum voor de Gezondheidszorg
Centre Hospitalier Universitaire de Liege
Conditions:
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Currently, most patients with an anterior cruciate ligament (ACL) injury undergo surgery. There is a general belief that surgical reconstruction is necessary to return to sport safely and to limit pre...
Eligibility Criteria
Inclusion
- Rotational trauma to a previously uninjured knee within the preceding 4 weeks
- Medical diagnosis of ACL insufficiency including MRI (both partial and complete ruptures)
- Minimum of 18 years
Exclusion
- Patient has history of a previous ACL injury or knee surgery to the index knee.
- Indication for acute surgery because of related injuries to the knee
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Female who is pregnant. Since MRI assessment cannot be performed.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04408690
Start Date
September 15 2020
End Date
March 3 2023
Last Update
November 15 2023
Active Locations (2)
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1
UZ Leuven
Leuven, Belgium, 3000
2
CHU Liège
Liège, Belgium, 4000