Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
IODA
Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
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
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2028
ExpectedJune 28, 2024
June 1, 2024
3 years
February 10, 2023
June 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical effectiveness (long-term)
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
12 months post-injury
Clinical effectiveness (short-term)
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
7 months post-injury
Secondary Outcomes (1)
Prediction analysis to identify patient-specific factors that predict whether (or not) a patient will require delayed surgery
36 months post-injury
Study Arms (2)
Conservative treatment
EXPERIMENTALRehabilitation and optional delayed ACL reconstruction
Immediate ACL reconstruction
EXPERIMENTALImmediate ACL reconstruction + rehabilitation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- Belgian Health Care Knowledge Centrecollaborator
- Jessa Ziekenhuis Hasseltcollaborator
- Centre Hospitalier Universitaire de Liegecollaborator
- Clinique Saint-Luc Bougecollaborator
- University Hospital Brusselcollaborator
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
Related Publications (1)
Smeets A, Ghafelzadeh Ahwaz F, Bogaerts S, Berger P, Peers K. Comparison of immediate versus optional delayed surgical repair for treatment of acute anterior cruciate ligament injury through a parallel, multicentric, pragmatic randomized controlled trial - IODA trial. BMC Sports Sci Med Rehabil. 2024 Jan 18;16(1):22. doi: 10.1186/s13102-024-00816-6.
PMID: 38238809DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 28, 2023
Study Start
March 2, 2023
Primary Completion
March 2, 2026
Study Completion (Estimated)
March 2, 2028
Last Updated
June 28, 2024
Record last verified: 2024-06