Actively Recruiting
Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-06-28
280
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
B
Belgian Health Care Knowledge Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Currently, most patients with an anterior cruciate ligament injury undergo surgery. There is a general belief that surgical reconstruction is necessary to safely return to sports and to prevent early knee osteoarthritis or additional meniscus injuries. But there is insufficient scientific evidence to support this belief. Moreover, several studies show that surgical reconstruction of the cruciate ligament does not guarantee successful return to sports or the prevention of osteoarthritis and secondary meniscus injuries. Therefore, immediate surgery after an anterior cruciate ligament injury is questioned. So far, only two RCTs (KANON study and COMPARE study) have assessed this, and they could not show that immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or additional meniscal injuries) compared to a conservative approach consisting of rehabilitation and late surgery for persistent knee instability. Therefore, this additional multicenter RCT, aims to 1) verify these results and 2) to identify predictors that predict which patients in the conservative group will not require late surgery. This has not been investigated to date. It is suspected that factors such as symptoms, strength, findings on the MRI scan and psychological factors may play a role in whether or not a patient will be able to successfully rehabilitate without surgical repair. This information is invaluable to physicians because it allows them to decide which treatment is best for the patient.
CONDITIONS
Official Title
Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rotational trauma to a knee with no previous serious injury and medical advice sought within 4 weeks after the injury
- Medical diagnosis of ACL insufficiency confirmed by MRI, including partial or complete ruptures
- At least 16 years old
You will not qualify if you...
- History of previous ACL injury or knee surgery on the affected knee
- Need for acute surgery due to related knee injuries
- Female who is pregnant or plans pregnancy within the first 4 months of the trial due to MRI restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
A
Annemie Smeets, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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