Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
Recruiting now · Not applicable
Conditions studied: ACL Injury
In brief
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.
Key facts
- Study ID
- NCT05747079
- Run by
- Universitaire Ziekenhuizen KU Leuven
- People needed
- 280
- Starts
- 2023-03-02
- Expected to finish
- 2028-03-02
- Last updated by the study team
- 2024-06-28
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Rotational trauma to a knee that had no previous serious injury and for which medical advice was sought within 4 weeks after the injury.
- Medical diagnosis of ACL insufficiency including MRI (both partial and complete ruptures)
- Minimum of 16 years
You may not qualify if…
- Participant has a history of a previous ACL injury or knee surgery to the index knee
- Indication for acute surgery because of related injuries to the knee
- Female who is pregnant or plans to become pregnant in the first 4 months of the trial. Since MRI assessment cannot be performed.
Where it is running
- UZ Leuven — Leuven, Belgium (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.