Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury (IODA)
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| ClinicalTrials.gov Identifier: NCT04408690 |
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Recruitment Status :
Recruiting
First Posted : May 29, 2020
Last Update Posted : October 20, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anterior Cruciate Ligament Injuries | Procedure: Immediate anterior cruciate ligament reconstruction Other: Rehabilitation Procedure: Optional delayed anterior cruciate ligament reconstruction | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 15, 2020 |
| Estimated Primary Completion Date : | January 1, 2021 |
| Estimated Study Completion Date : | May 1, 2021 |
| 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 |
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. 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. |
- 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
- 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 ]Number of patients that complete all assessments (at baseline and 3 month follow-up)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408690
| Contact: Annemie Smeets, PhD | +32 16345965 | annemie.smeets@uzleuven.be | |
| Contact: Koen Peers, MD, PhD | +32 16342185 | koen.peers@uzleuven.be |
| Belgium | |
| UZ Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Koen Peers, MD, PhD +32 16342185 koen.peers@uzleuven.be | |
| CHU Liège | Not yet recruiting |
| Liège, Belgium, 4000 | |
| Contact: Jean-François Kaux, MD, PhD +32 43668473 jfkaux@chuliege.be | |
| Principal Investigator: | Koen Peers, MD, PhD | UZ Leuven |
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT04408690 |
| Other Study ID Numbers: |
S62004 |
| First Posted: | May 29, 2020 Key Record Dates |
| Last Update Posted: | October 20, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Wounds and Injuries Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries |