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

A Pilot Study to Investigate the Feasibility of Conducting a Randomized Controlled Trial That Compares Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: Rehabilitation; Procedure: Optional delayed anterior cruciate ligament reconstruction; Procedure: Immediate anterior cruciate ligament reconstruction

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • CHU Liege

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation and optional delayed ACL reconstruction	Other: 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.; Procedure: 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.
Active Comparator: Immediate ACL reconstruction + rehabilitation	Other: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility to recruit patients: Number of eligible patients that sign the informed consent	Number of eligible patients that sign the informed consent	4 months after first patient in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the protocol: Number of patients that complete all assessments	Number of patients that complete all assessments (at baseline and 3 month follow-up)	When 5 patients per site have completed the 3 month follow-up visit

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Centre Hospitalier Universitaire de Liege; Federaal Kenniscentrum voor de Gezondheidszorg
• Investigators: Principal Investigator: Koen Peers, MD, PhD, UZ Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: S62004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No