Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury

NCT ID: NCT04408690

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2023-03-03

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 premature knee osteoarthrosis or additional meniscal damage. However, there is unsufficient scientific evidence for this belief. Moreover, several studies show that a reconstruction does not guarantee successful return to sports or the prevention of osteoarthritis or meniscal injuries at all. Therefore, an immediate surgery after an ACL injury is more and more questioned. The only qualitative RCT that exists (KANON trial) could not demonstrate that an immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or incidental meniscal damage) compared to a conservative approach consisting of progressive rehabilitation and delayed surgery if there was persistent knee instability.

In a future multicenter RCT the investigators want to 1) verify these results and 2) search for predictors that predict which patients from the conservative group do well without delayed surgery. This information is invaluable to physicians as it allows them to decide which treatment is best for the patient.

Before performing a large, adequately-powered RCT that compares both treatment options, the investigators will run a pilot study that assesses the feasibility to recruit ACL patients for such RCT. This seems necessary, as many patients still believe that timely surgery is a prerequisite for restoring knee function, for returning to sports and for preventing cartilage degeneration. These preferences for surgery might affect recruitment and adherence to the protocol. Therefore, a pilot study will performed that demonstrates whether a large RCT is feasible with regard to 1) participant recruitment, 2) adherence to the treatment arm they were allocated to and 3) protocol feasibility. The findings of this pilot study will help deciding about progressing to a future definitive RCT.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rehabilitation and optional delayed ACL reconstruction

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria, but it is the physiotherapist's choice how to implement these guidelines in clinical practice.

Optional delayed anterior cruciate ligament reconstruction

Intervention Type: PROCEDURE

If a patient complains about persistent symptomatic instability of the knee or the inability to progress in rehabilitation, delayed surgery can be considered. ACL insufficiency induced instability in combination with a positive pivot shift and an additional MRI are needed to confirm the cause of instability.

This surgery will not be performed within the first 12 weeks after the ACL injury.

Immediate ACL reconstruction + rehabilitation

Group Type: ACTIVE_COMPARATOR

Immediate anterior cruciate ligament reconstruction

Intervention Type: PROCEDURE

No guidelines on type of ACL reconstruction will be imposed to keep the trial pragmatic. The decision of graft type and surgery technique is a clinical decision made by the orthopaedic surgeons of the participating centra.

This surgery will be performed within 12 weeks after the ACL injury.

Rehabilitation

Intervention Type: OTHER

All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria, but it is the physiotherapist's choice how to implement these guidelines in clinical practice.

Interventions

Immediate anterior cruciate ligament reconstruction

No guidelines on type of ACL reconstruction will be imposed to keep the trial pragmatic. The decision of graft type and surgery technique is a clinical decision made by the orthopaedic surgeons of the participating centra.

This surgery will be performed within 12 weeks after the ACL injury.

Intervention Type: PROCEDURE

Rehabilitation

All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria, but it is the physiotherapist's choice how to implement these guidelines in clinical practice.

Intervention Type: OTHER

Optional delayed anterior cruciate ligament reconstruction

If a patient complains about persistent symptomatic instability of the knee or the inability to progress in rehabilitation, delayed surgery can be considered. ACL insufficiency induced instability in combination with a positive pivot shift and an additional MRI are needed to confirm the cause of instability.

This surgery will not be performed within the first 12 weeks after the ACL injury.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federaal Kenniscentrum voor de Gezondheidszorg

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koen Peers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven

Leuven, , Belgium

CHU Liège

Liège, , Belgium

Countries

Belgium

References

Ghafelzadeh Ahwaz F, Smeets A, Bogaerts S, Berger P, Peers K. The feasibility of conducting a randomized controlled trial that compares immediate versus optional delayed surgical repair for treatment of acute Anterior cruciate ligament injury-results of the IODA pilot trial. Pilot Feasibility Stud. 2025 May 8;11(1):63. doi: 10.1186/s40814-025-01652-2.

Reference Type: DERIVED

PMID: 40340976 (View on PubMed)

Smeets A, Ghafelzadeh Ahwaz F, Bogaerts S, De Groef A, Berger P, Kaux JF, Daniel C, Croisier JL, Delvaux F, Laenen A, Staes F, Peers K. Pilot study to investigate the feasibility of conducting a randomised controlled trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute Anterior cruciate ligament injury: IODA pilot trial. BMJ Open. 2022 Mar 11;12(3):e055349. doi: 10.1136/bmjopen-2021-055349.

Reference Type: DERIVED

PMID: 35277406 (View on PubMed)

Other Identifiers

S62004

Identifier Type: -

Identifier Source: org_study_id