ACL InjuryIODANCT05747079
Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
A study testing Rehabilitation, Optional delayed anterior cruciate ligament reconstruction and Immediate anterior cruciate ligament reconstruction in people with ACL Injury, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- ACL Injury
- What is being tested?
- Rehabilitation, Optional delayed anterior cruciate ligament reconstruction and Immediate anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Mar 2023to 2 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Koen Peers, MD, PhD, +32 16342185, koen.peers@uzleuven.be
About this study
Official title: Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial
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.
- Conditions
- ACL Injury
- Being tested
- Rehabilitation, Optional delayed anterior cruciate ligament reconstruction, Immediate anterior cruciate ligament reconstruction
- Keywords
- ACL, RCT, Conservative treatment, ACL 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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Experimental | Rehabilitation and optional delayed ACL reconstruction Receives: Other: Rehabilitation; Procedure: Optional delayed anterior cruciate ligament reconstruction |
| Immediate ACL reconstruction | Experimental | Immediate ACL reconstruction + rehabilitation Receives: Other: Rehabilitation; Procedure: Immediate anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness (long-term)
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
Measured: 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)
Measured: 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
Dependent variable = whether or not delayed surgery is performed (binary event)
Independent variables (candidate predictors):
- Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life at baseline
- MRI findings at baseline scored with the modified ACLOAS (Anterior Cruciate Ligament OsteoArthritis Score)
- Degree of hemarthrosis determined by MRI at baseline
- Expectations regarding the effectiveness of physical therapy at baseline, measured with the illness perception questionnaire
- Pre-injury activity level, measured with the Tegner Activity Score
Measured: 36 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start2 Mar 2023
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Health Care Knowledge Centre, Jessa Hospital, Centre Hospitalier Universitaire de Liege, Clinique Saint-Luc Bouge, University Hospital Brussel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747079
- Sponsor's protocol ID
- S67021
- Acronym
- IODA
- Status last verified
- Jun 2024
- First submitted
- 10 Feb 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38238809
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute Anterior Cruciate Ligament Injury Through a Parallel, Multicentric, Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05747079
- Acronym / sponsor ID
- IODA / S67021
- Conditions
- ACL Injury
- Keywords
- ACL, RCT, Conservative treatment, ACL reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Belgian Health Care Knowledge Centre, Jessa Hospital, Centre Hospitalier Universitaire de Liege, Clinique Saint-Luc Bouge, University Hospital Brussel
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Mar 2028 (estimated)
- First posted
- 28 Feb 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Experimental | Other: Rehabilitation, Procedure: Optional delayed anterior cruciate ligament reconstructionRehabilitation and optional delayed ACL reconstruction |
| Immediate ACL reconstruction | Experimental | Other: Rehabilitation, Procedure: Immediate anterior cruciate ligament reconstructionImmediate ACL reconstruction + rehabilitation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| 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 | Conservative treatment, Immediate 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 | Conservative treatment |
| 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 |
Primary outcome
Clinical effectiveness (long-term)
Time frame: 12 months post-injury
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
Clinical effectiveness (short-term)
Time frame: 7 months post-injury
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
1 secondary outcome
Prediction analysis to identify patient-specific factors that predict whether (or not) a patient will require delayed surgery
Time frame: 36 months post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 38238809Smeets 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.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation, Optional delayed anterior cruciate ligament reconstruction and Immediate anterior cruciate ligament reconstruction in people with ACL Injury, run by Universitaire Ziekenhuizen KU Leuven at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemie Smeets, phd (+32 16 37 91 02, annemie.smeets@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness (long-term) (time frame: 12 months post-injury). The study lists 2 primary outcomes in all. 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 NCT05747079, which also lists 1 linked publication.
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 28 Jun 2024.