Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
ConditionACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorNYU Langone Health
About this trial
The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with bone-tendon-bone autograft with and without internal bracing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing ACLR with BTB autograft
Patients ages 18-35, inclusive
Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee
Disqualifiers
Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs
Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2
History of autoimmune or inflammatory disease
Prior ipsilateral knee ligament surgery or multi-ligament knee injury
Trial design
Design model
Parallel
Treatments tested in this trial
Arthrex Internal Brace
DeviceThe Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
ACL Reconstruction
Procedure/SurgeryAll patients will undergo ACL reconstruction (ACLR) with or without an internal brace. ACLR technique will be standardized to standard anteromedial (AM) portal femoral drilling to ensure consistency between surgeons.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Internal BraceExperimental treatment 2 interventions
Group B: Standard ACLRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Side to side difference in laxity as measured by the KT-1000 Arthrometer
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.
Time frame
Month 12 Post-Operation2
Side to side difference in laxity as measured by the KT-1000 Arthrometer
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.
Time frame
Month 24 Post-OperationSecondary outcomes
1
Pivot Shift Grade
The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.
Time frame
Month 12 Post-Operation2
Pivot Shift Grade
The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.
Time frame
Month 24 Post-Operation3
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation
Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score.
Time frame
Baseline, Month 12 Post-Operation4
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation
Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score.
Time frame
Baseline, Month 24 Post-OperationSponsors and contacts
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Source ClinicalTrials.gov