Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-39
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • post-surgical functional bracing

    Device

    Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: With postoperative brace (DonJoy Defiance Pro)Experimental treatment 1 intervention
Group B: Without post-surgical functional bracingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 3, 6, 12, and 24 months

Secondary outcomes

1

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.

Time frame
Baseline and 3, 6, 12, and 24 months
2

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)

Time frame
Baseline and 3, 6, 12, and 24 months
3

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).

Time frame
Baseline and 3, 6, 12, and 24 months
4

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.

Time frame
Baseline and 3, 6, 12, and 24 months

Other outcomes

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