Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Annemie Smeets, phd
annemie.smeets@kuleuven.be
+32 16 37 91 02
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2028-03-02
Participants
Target number of participants: 280
Treatments
Experimental: Conservative treatment
Rehabilitation and optional delayed ACL reconstruction
Experimental: Immediate ACL reconstruction
Immediate ACL reconstruction + rehabilitation
Related Therapeutic Areas
Sponsors
Collaborators: Centre Hospitalier Universitaire de Liege, Clinique Saint-Luc Bouge, Belgian Health Care Knowledge Centre, Jessa Ziekenhuis Hasselt, University Hospital Brussel
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov