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
1 other identifier
interventional
29
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2023
CompletedNovember 15, 2023
November 1, 2023
2.5 years
May 25, 2020
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Feasibility of the protocol: Number of patients that complete all assessments
When 5 patients per site have completed the 3 month follow-up visit
Study Arms (2)
Rehabilitation and optional delayed ACL reconstruction
EXPERIMENTALImmediate ACL reconstruction + rehabilitation
ACTIVE COMPARATORInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UZ Leuven
Leuven, 3000, Belgium
CHU Liège
Liège, 4000, Belgium
Related Publications (2)
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.
PMID: 40340976DERIVEDSmeets 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.
PMID: 35277406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Koen Peers, MD, PhD
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2020
First Posted
May 29, 2020
Study Start
September 15, 2020
Primary Completion
March 3, 2023
Study Completion
March 3, 2023
Last Updated
November 15, 2023
Record last verified: 2023-11