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Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries (IODA)

Primary Purpose

ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rehabilitation
Optional delayed anterior cruciate ligament reconstruction
Immediate anterior cruciate ligament reconstruction
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury focused on measuring ACL, RCT, Conservative treatment, ACL reconstruction

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conservative treatment

Immediate ACL reconstruction

Arm Description

Rehabilitation and optional delayed ACL reconstruction

Immediate ACL reconstruction + rehabilitation

Outcomes

Primary Outcome Measures

Clinical effectiveness (long-term)
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
Clinical effectiveness (short-term)
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2023
Last Updated
September 1, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Belgian Health Care Knowledge Centre, Jessa Ziekenhuis Hasselt, Centre Hospitalier Universitaire de Liege, CHC Montlegia, Clinique Saint-Luc Bouge
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1. Study Identification

Unique Protocol Identification Number
NCT05747079
Brief Title
Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries
Acronym
IODA
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
March 2, 2026 (Anticipated)
Study Completion Date
March 2, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Belgian Health Care Knowledge Centre, Jessa Ziekenhuis Hasselt, Centre Hospitalier Universitaire de Liege, CHC Montlegia, Clinique Saint-Luc Bouge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
ACL, RCT, Conservative treatment, ACL reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative treatment
Arm Type
Experimental
Arm Description
Rehabilitation and optional delayed ACL reconstruction
Arm Title
Immediate ACL reconstruction
Arm Type
Experimental
Arm Description
Immediate ACL reconstruction + rehabilitation
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Optional delayed anterior cruciate ligament reconstruction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Immediate anterior cruciate ligament reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical effectiveness (long-term)
Description
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
Time Frame
12 months post-injury
Title
Clinical effectiveness (short-term)
Description
Knee Injury and Osteoarthritis Outcome Score - Subscale Quality of Life (score between 0-100, higher scores mean better outcome)
Time Frame
7 months post-injury
Secondary Outcome Measure Information:
Title
Prediction analysis to identify patient-specific factors that predict whether (or not) a patient will require delayed surgery
Description
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
Time Frame
36 months post-injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annemie Smeets, phd
Phone
+32 16 37 91 02
Email
annemie.smeets@kuleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Peers, MD, PhD
Phone
+32 16342185
Email
koen.peers@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Immediate Versus Optional Delayed Surgical Repair for Treatment of Acute ACL Injuries

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