Anterior Cruciate Ligament InjuriesPhase 3IODANCT04408690
Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury
A Phase 3 study testing Immediate anterior cruciate ligament reconstruction, Rehabilitation and Optional delayed anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Injuries, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Immediate anterior cruciate ligament reconstruction, Rehabilitation and Optional delayed anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Sep 2020to 3 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Immediate anterior cruciate ligament reconstruction, Rehabilitation, Optional delayed anterior cruciate ligament reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate anterior cruciate ligament reconstructionProcedure or surgery
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.
RehabilitationOther
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 reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation and optional delayed ACL reconstruction | Experimental | Not described Receives: Other: Rehabilitation; Procedure: Optional delayed anterior cruciate ligament reconstruction |
| Immediate ACL reconstruction + rehabilitation | Active comparator | Not described Receives: Procedure: Immediate anterior cruciate ligament reconstruction; Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to recruit patients: Number of eligible patients that sign the informed consent
Number of eligible patients that sign the informed consent
Measured: 4 months after first patient in
Secondary outcomes (1)
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)
Measured: When 5 patients per site have completed the 3 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start15 Sep 2020
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Federaal Kenniscentrum voor de Gezondheidszorg, Centre Hospitalier Universitaire de Liege
- Responsible party
- Sponsor
- Investigators
- Koen Peers, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408690
- Sponsor's protocol ID
- S62004
- Acronym
- IODA
- Status last verified
- Nov 2023
- First submitted
- 25 May 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40340976Smeets 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.
PubMed 35277406
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04408690
- Acronym / sponsor ID
- IODA / S62004
- Conditions
- Anterior Cruciate Ligament Injuries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Federaal Kenniscentrum voor de Gezondheidszorg, Centre Hospitalier Universitaire de Liege
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation and optional delayed ACL reconstruction | Experimental | Other: Rehabilitation, Procedure: Optional delayed anterior cruciate ligament reconstruction |
| Immediate ACL reconstruction + rehabilitation | Active comparator | Procedure: Immediate anterior cruciate ligament reconstruction, Other: Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate anterior cruciate ligament reconstructionNo 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. | Procedure or surgery | Immediate ACL reconstruction + rehabilitation |
| RehabilitationAll 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. | Other | Immediate ACL reconstruction + rehabilitation, Rehabilitation and optional delayed ACL reconstruction |
| Optional delayed anterior cruciate ligament reconstructionIf 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. | Procedure or surgery | Rehabilitation and optional delayed ACL reconstruction |
Primary outcome
Feasibility to recruit patients: Number of eligible patients that sign the informed consent
Time frame: 4 months after first patient in
Number of eligible patients that sign the informed consent
1 secondary outcome
Feasibility of the protocol: Number of patients that complete all assessments
Time frame: When 5 patients per site have completed the 3 month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 40340976Ghafelzadeh 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.
- Derived from this study: PubMed 35277406Smeets 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Peers, MD, PhD principal investigator
UZ Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immediate anterior cruciate ligament reconstruction, Rehabilitation and Optional delayed anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Injuries, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to recruit patients: Number of eligible patients that sign the informed consent (time frame: 4 months after first patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.