Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04408690

Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury — IODA  

Anterior Cruciate Ligament Injuries Clinical Trial

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

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04408690
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Completed
Phase Phase 3
Start date September 15, 2020
Completion date March 3, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04062578 - Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players N/A
Recruiting NCT05461326 - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT N/A
Completed NCT05109871 - Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque N/A
Completed NCT05504018 - Clinical and Radiological Evaluation of ACL Reconstruction Results N/A
Recruiting NCT06185231 - Investigation of the Effects of Vibration Therapy on Pain, Functionality, and Proprioception After ACL Injury N/A
Recruiting NCT03968913 - Biologic Therapy to Prevent Osteoarthritis After ACL Injury Early Phase 1
Recruiting NCT06222814 - Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee N/A
Recruiting NCT05614297 - Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
Active, not recruiting NCT05184023 - The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR N/A
Completed NCT04906538 - Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique Phase 2/Phase 3
Completed NCT05014009 - The Influence of Neuromuscular Training on Whole-body Movement Strategies and Knee Mechanics During Change-of-direction Tasks in Sports Science Students N/A
Not yet recruiting NCT06083818 - Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus N/A
Recruiting NCT05584020 - Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury N/A
Completed NCT04580290 - Jewel ACL Post Market Clinical Follow Up Study
Recruiting NCT04888052 - Prolonged Preoperative Rehabilitation in ACL Rupture. N/A
Not yet recruiting NCT05580133 - All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)
Recruiting NCT04162613 - Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction
Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A
Recruiting NCT06201442 - Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
Not yet recruiting NCT05068297 - The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction N/A