About this trial
Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with unilateral complete ACL injury
patients involved in sports and the desire to return to sports
patients undergoing quadriceps autograft ACL reconstruction
must be 14 to 39 years old
Disqualifiers
multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
concomitant femoral, tibial, or patellar fracture(s)
patients with significant osteoarthritis
Trial design
Parallel
Treatments tested in this trial
post-surgical functional bracing
DeviceQuadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace
Treatment groups
Trial outcomes
Primary outcomes
Change in ACL-return to sport index (ACL-RSI) Scores
The ACL-Return to Sport after Injury scale (ACL-RSI) is a 12-item survey that measures psychological readiness to return to sport after an ACL injury or surgery. It uses a visual analog scale from 0 to 100, where higher scores indicate greater psychological readiness. The total score is calculated as a percentage of the 12-item total score. A higher ACL-RSI score indicates a greater level of psychological readiness for returning to sport.
Secondary outcomes
Tampa Scale Kinesiophobia 11 (TSK-11) Score
The TSK-11 (Tampa Scale for Kinesiophobia) is a 11-item questionnaire assessing fear of movement/re-injury, scored on a 4-point Likert scale (1-4) with a total score range of 11-44, where higher scores indicate greater fear of pain and movement. Lower scores (closer to 11): Indicate minimal or no kinesiophobia (fear of movement/re-injury). Higher scores (closer to 44): Suggest a greater degree of kinesiophobia.
International Knee Documentation Committee (IKDC) Score
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Lysholm score
The Lysholm Knee Scoring Scale is a 100-point questionnaire used to assess knee function and is often used to evaluate knee injuries and surgeries, with higher scores indicating better function and fewer symptoms. A higher score indicates better knee function and fewer symptoms. Scores are often categorized as excellent (95-100), good (84-94), fair (65-83), and poor (\<65).
Forgotten Joint Score (FJS-12)
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure designed to assess how much a patient is aware of their artificial join in everyday life, with higher scores indicating less awareness and better surgical outcomes. Each response is assigned a score (0-4), and the scores are summed and transformed to a 0-100 scale, with higher scores indicating less awareness of the joint. Interpretation: A higher score suggests that the patient is less aware of their joint, indicating a better outcome and higher satisfaction with the surgery.
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