Clinical trial NCT05747079: Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
Official title: Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Injury
Keywords: ACL
RCT
Conservative treatment
ACL reconstruction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgian Health Care Knowledge Centre
name: Jessa Ziekenhuis Hasselt
name: Centre Hospitalier Universitaire de Liege
name: Clinique Saint-Luc Bouge
name: University Hospital Brussel
First posted: 2023-02-28
Enrollment: 280
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Clinical effectiveness (long-term)
timeFrame: 12 months post-injury
measure: Clinical effectiveness (short-term)
timeFrame: 7 months post-injury
Secondary outcomes:
measure: Prediction analysis to identify patient-specific factors that predict whether (or not) a patient will require delayed surgery
timeFrame: 36 months post-injury
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: