A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction (BEAR-MOON)
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|ClinicalTrials.gov Identifier: NCT03776162|
Recruitment Status : Not yet recruiting
First Posted : December 14, 2018
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Tear||Procedure: ACL Reconstruction (Bone Patellar Tendon Bone Graft) Device: Bridge Enhanced ACL Repair (BEAR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multi-center, 2-arm, 1:1 permuted block randomized controlled clinical trial, with a blinded patient and outcome assessor.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Treatment will be determined by intra-operative computer-generated randomization after the diagnostic arthroscopy and participant treatment assignment will not be reported to the participant until termination of the study observation period. Research Assessments by Independent Blinded Assessor for assessments of study endpoints and safety. KT-1000 knee laxity arthrometer testing, International Knee Documentation Committee (IKDC) patient-reported outcome score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Marx knee activity rating scale, Anterior Knee Pain Scale, Quadriceps Strength, Hop testing, and physical examination. The physical therapist implementing the post-surgical rehabilitation will be blinded to the treatment group.|
|Official Title:||BEAR - MOON: A Two Arm Non-Inferiority Randomized Clinical Trial Comparing ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Active Comparator: ACL Reconstruction(BPTB Graft)
Procedure/Surgery ACL Reconstruction (Bone Patellar Tendon Bone Graft): Standard of care surgical procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.
Procedure: ACL Reconstruction (Bone Patellar Tendon Bone Graft)
Standard of care procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.
Experimental: Bridge Enhanced ACL Repair
Procedure/Surgery Bridge Enhanced ACL Repair (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to group into.
Device: Bridge Enhanced ACL Repair (BEAR)
The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to group into.
- KT-1000 [ Time Frame: KT-1000 instrumented knee laxity measure 2 years after surgery (difference from contralateral knee) ]Co-primary Outcome measure: Knee stability or the antero-posterior (AP) knee laxity will be determined using a KT-1000 arthrometer at the 30lb force setting on both knees of the subject at 6 months, 1 and 2 years after surgery. The primary endpoint will be 2 year KT-1000. Both left and right knees will be covered with a sleeve so the trained examiner cannot tell which the operated knee is or which procedure the patient had. Values for both knees will be recorded. For knee laxity 2.5 mm in the side-to-side difference measurements will be taken as the non-inferiority margin for the 2 year post-operative comparison of patients in the bridge-enhanced repair group and the ACL reconstruction groups.Testing will be performed by experienced, certified athletic trainers, physical therapists or physician assistants trained using standardized equipment according to the MOON protocol.
- IKDC (International Knee Documentation Committee) Score [ Time Frame: Validated Patient Reported IKDC Subjective Score Instrument 2 years after surgery (change from baseline) ]The IKDC patient-reported outcome measure instrument will be completed by patients pre-operatively, then at 3 and 6 months, 1 year and at the final 2 year visit after surgery. The primary endpoint will be evaluated at 2 years. The IKDC non-inferiority margin for BEAR vs. autograft patellar tendon will be set at <16 points. The IKDC is a patient reported outcome measure 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).
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Validated Patient Reported KOOS Subjective Score Instrument 2 years after surgery ]The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcome measurement instrument to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short and long-term consequences of knee injury and primary osteoarthritis. It is a validated patient-reported outcomes measure to be administered by the research coordinator at the same time points as the IKDC (preoperatively, 3 and 6 months, 1 and 2 years). There are 5 subscales (Pain, Symptoms, Activities of Daily Living (ADL), Sports and Recreation, and Knee related Quality of life). The minimum clinically relevant difference is 8 points on a 100 point scale for each of the five subscales.The last week is taken into consideration when answering the questions. Standardized answer options are given and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
- MARX Activity (Marx Activity Rating Scale) [ Time Frame: MARX Activity 2 years after surgery ]The Marx Activity Scale is a validated patient-reported measure to be administered by the research coordinator to the patient preoperatively and at 1 and 2 years post-operatively. MARX focuses on four activity points: running, deceleration, cutting (changing directions while running), and pivoting. Patients are asked to indicate approximately how many times in the past 12 months they performed each of the activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation. The MARX rating scale is not based on participation in specific sporting activities. Instead, patients are asked about different components of physical function (e.g., running and pivoting) that are common to different sports.
- Anterior Knee Pain Scale (AKPS) [ Time Frame: AKPS 2 years after surgery ]The AKPS is a validated patient-reported outcomes measure to be administered by the research coordinator to patients at the same time points as the IKDC (preoperatively, 3 and 6 months, 1 and 2 years). This tool is designed to measure patellofemoral pain symptoms. The BEAR-MOON study will utilize the 6-item short version (walking, squatting, jumping, pain, swelling, abnormal kneecap movements). Minimum score is 0 points (most painful) and maximum score is 100 points (no pain).
- Quadriceps Strength Testing [ Time Frame: Quadriceps Strength 2 years after surgery ]Measurement of quadriceps strength on both knees will be performed at 6 months, and 1 and 2 years after surgery using a hand held dynamometer. Both sides will be covered with a sleeve so the blinded examiner cannot tell which the knee was the operated knee or which procedure was performed. Values for both knees will be recorded.
- Hop Test Limb Difference [ Time Frame: Hop Test Limb Difference 2 years after surgery ]Hop functional testing will be performed by a trained physical therapist or athletic trainer on a strict protocol as performed and published by MOON. This will be performed at 6 month, 1 and 2 years. The measurement of interest is the difference between hop distances using the normal leg and ACL injured leg. Single leg hop tests are a method to determine ability to return to high-level athletics following knee surgery. They are commonly used during the return to function phase in an anterior cruciate ligament (ACL) rehabilitation protocol to assess the functional stability of the knee
- Active Knee Range of Motion [ Time Frame: Active Knee Range of Motion 2 years after surgery ]Range of motion will be measured using a goniometer. Both sides will be covered with a sleeve so the licensed examiner cannot tell which the knee was the operated knee or which procedure was performed. Values for both knees will be recorded.
- Lachman Testing [ Time Frame: Lachman Testing 2 years after surgery ]The Lachman Test will be measured by a blinded examiner at 6 months, 1 year and at the final 2 year visit after surgery. Both knees will be covered with a sleeve in order to keep the assessor blinded to the operative knee and which procedure was performed. The Lachman test is used to identify the integrity of the ACL.
- Number of Participants with Knee Infection [ Time Frame: Knee Infection 2 years after surgery ]Infection is defined as a return to the operating room for a washout of the knee; intravenous (IV) antibiotics to treat the infection.
- Number of Participants with Treatment Failure [ Time Frame: Treatment Failure 2 years after surgery ]Treatment failure will include re-injury; knee laxity >6mm without re-injury; MRI confirmation of graft tear; or a physical examination that proves a graft tear.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776162
|Contact: Carrie B Melgaard, MS||(216) firstname.lastname@example.org|
|United States, Missouri|
|Washington University St. Louis||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Amanda Braun 314-362-3768 email@example.com|
|Principal Investigator: Rick Wright, MD|
|United States, Ohio|
|Cleveland Clinic||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Brian Strippy 216-518-3491 firstname.lastname@example.org|
|Principal Investigator: Kurt P Spindler, MD|
|Sub-Investigator: Lutul Farrow, MD|
|Ohio State University||Not yet recruiting|
|Columbus, Ohio, United States, 43202|
|Contact: Jordan Brauning 614-293-2761 Jordan.email@example.com|
|Principal Investigator: Christopher Kaeding, MD|
|Sub-Investigator: David Flanigan, MD|
|United States, Rhode Island|
|Brown University/Rhode Island Hospital||Not yet recruiting|
|Providence, Rhode Island, United States, 02906|
|Contact: Cindi Chrostek 401-444-4164 firstname.lastname@example.org|
|Principal Investigator: Brett Owens, MD|
|Sub-Investigator: Paul Fadale, MD|
|Sub-Investigator: Michael Hulstyn, MD|
|United States, Tennessee|
|Vanderbilt University||Not yet recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Rosemary Sanders 615-322-7121 email@example.com|
|Principal Investigator: Charlie Cox, MD|
|Principal Investigator:||Kurt P Spindler, MD||The Cleveland Clinic|