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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
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Boston Children’s Hospital
Information provided by (Responsible Party):
Kurt Spindler, MD, The Cleveland Clinic

Brief Summary:
This study is designed to evaluate bridge-enhanced ACL repair (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. The BEAR technique is investigational and involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing an absorbable scaffold for the ligament ends to grow into. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. However, no human data yet support that, and this trial will conclude before such a benefit can be observed. All patients 18-40 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial. Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years.

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

Detailed Description:
The study population will include active and otherwise healthy patients of both genders, all races, and between 18-40 years old at any of five locations, who elect to undergo primary surgery for a torn ACL within 50 days of injury. Approximately 100 patients will receive each of the experimental BEAR surgery and the comparative control BPTB reconstruction surgery, with each group distributed similarly across the five medical centers where the trial is being conducted: Cleveland Clinic, Vanderbilt University, Ohio State University, Rhode Island Hospital/University Orthopedics, and Washington University in St. Louis. The study intervention uses a BEAR Implanted scaffold, which is placed between the torn ends of the ruptured ACL. The BEAR scaffold is resorbed over 4 to 8 weeks, during which period it promotes repair of the ACL tissue in the gap between the torn ends. The device provides a stable provisional scaffold to facilitate intra-articular repair of the torn ACL ligament, where without the implant device, healing does not occur. The results of this BEAR procedure will be compared against ACL reconstruction using a BPTB autograft. This technique consists of removing the torn ACL tissue, harvesting patellar tendon, and grafting that tendon within tunnels in the bone to reconstruct or replace the torn ACL. The study duration is five years. Surgery will occur at most 50 days after the patient's ACL is torn, with two year follow-up and a three month window for the final follow-up examination, for a maximum enrollment period for each patient of approximately 2 years and five months (29 months). Randomization will occur during the surgery, and patients will be informed of their treatments at conclusion of their participation. The two research time points are 1 and 2 years, when assessments will be conducted by an independent examiner masked to the type of surgery the patient received. With the exception of the RCT consenting process, use of the BEAR implant, and the blinded assessment process, clinical care will be standard practice following surgical treatment for a torn ACL.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. 18-40 years of age
  2. Complete ACL tear as confirmed by MRI
  3. Selected surgical treatment of ACL injury
  4. Believed to be a surgical candidate for ACL reconstruction by treating physician
  5. Time from injury to surgery is ≤50 days
  6. Stated willingness to comply with all study procedures for the duration of the study, including lifestyle, activity, and sports restrictions
  7. Provision of signed and dated informed consent form

EXCLUSION CRITERIA AT PRE-OPERATIVE EXAM

An individual who meets any of the following criteria, either during a pre-operative exam or during intraoperative arthroscopic evaluation, will be excluded from participation in this study:

  1. Any prior surgery on affected or unaffected knee
  2. Confirmed or suspected contralateral ACL tear
  3. ACL tear found to be only partial and the treating physician feels it does not require surgery because it is "stable"
  4. Diagnosis of posterolateral corner injury (complete lateral collateral ligament tear, biceps femoris tendon avulsion, arcuate ligament tear, popliteus ligament tear) that requires concurrent or staged surgical treatment
  5. Diagnosis of Grade 3 medial collateral injury that requires concurrent or staged surgery
  6. Insufficient ACL tissue on MRI
  7. Diagnosis of complete patellar dislocation
  8. Diagnosis of complete patellar tendon or quadriceps tear
  9. Obesity with a BMI ≥35
  10. Does not speak or understand English
  11. History of regular tobacco or nicotine use in any form
  12. History of drug or alcohol abuse
  13. Inability to take oral medications
  14. Use of intra-articular corticosteroids in the affected knee within last 6 months
  15. Chronic use of oral corticosteroids (e.g., to treat lupus, rheumatoid arthritis, asthma, etc.)
  16. History of prior infection in knee
  17. History of chemotherapy treatment
  18. History of sickle cell disease
  19. History of anaphylaxis
  20. Any condition that, in the opinion of the investigator, could affect healing (e.g., diabetes, inflammatory arthritis, etc.)
  21. Pregnancy or lactation
  22. Known allergic reactions to meat products or collagen
  23. Known allergy to bovine collagen, bovine gelatin, or other bovine products
  24. Known adverse reaction to any bovine product
  25. Febrile illness within 7 days
  26. Treatment with another investigational drug or other intervention, either concurrently or previously, that would interfere with surgical healing

EXCLUSION CRITERIA AT INTRAOPERATIVE ARTHROSCOPIC EVALUATION

  1. Time from injury to surgery has exceeded 50 days
  2. No ACL tear found upon arthroscopic inspection
  3. ACL tear found to be only partial, with normal pivot shift and endpoint, and does not require surgery
  4. Displaced bucket handle meniscal injury requiring repair
  5. Diagnosis of full-thickness chondral injury of Grade 3 or 4, or that requires more than microfracture (i.e., osteochondral autograft transplant), on either condyle
  6. Unrecognized lateral or medial sided Grade 3 ligamentous injury that requires concurrent or staged surgery
  7. Tibial stump length is < 1cm
  8. Tibial footprint attachment is < 50% intact
  9. Any other reason the ACL stump should be deemed irreparable (e.g., tissue quality too poor to hold suture)

Information from the National Library of Medicine

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


Contacts
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Contact: Carrie B Melgaard, MS (216) 444-6162 melgaac@ccf.org

Locations
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United States, Missouri
Washington University St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Amanda Braun    314-362-3768    hassa@wudosis.wustl.edu   
Principal Investigator: Rick Wright, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Brian Strippy    216-518-3491    strippb@ccf.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.brauning@osumc.edu   
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    cchostek@lifespan.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    rosemary.a.sanders@vumc.org   
Principal Investigator: Charlie Cox, MD         
Sponsors and Collaborators
The Cleveland Clinic
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Boston Children’s Hospital
Investigators
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Principal Investigator: Kurt P Spindler, MD The Cleveland Clinic

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Responsible Party: Kurt Spindler, MD, Vice Chairman of Research Orthopaedic Research Institute, Academic Director, Cleveland Clinic Sports Health, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03776162     History of Changes
Other Study ID Numbers: G180167
R01AR074131-01 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The public will have access to the published results of the NIH funded research. Scientists will be required to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Per National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) policy, 2 years after posting of study results.
Access Criteria: This study will comply with the NIH Data Sharing Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
URL: https://grants.nih.gov/grants/policy/data_sharing/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Kurt Spindler, MD, The Cleveland Clinic:
Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Repair
Knee Surgery

Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries