BEAR - MOON: A Two Arm Non-Inferiority Randomized Clinical Trial Comparing ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- IKDC (International Knee Documentation Committee) Score
研究概览
简要总结
This study is designed to evaluate bridge-enhanced ACL restoration (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 FDA approved and involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing an absorbable implant 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 18-55 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.
详细描述
The study population will include active and otherwise healthy patients of both genders, all races, and between 18-55 years old at any of six 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 six medical centers where the trial is being conducted: Cleveland Clinic, Vanderbilt University, Ohio State University, Rhode Island Hospital/University Orthopedics, and University of Colorado . The study intervention uses a BEAR implant, which is placed between the torn ends of the ruptured ACL. The BEAR implant 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 sponge 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •18-55 years of age
- •Complete ACL tear as confirmed by MRI
- •Selected surgical treatment of ACL injury
- •Believed to be a surgical candidate for ACL reconstruction by treating physician
- •Time from injury to surgery is ≤50 days
- •Stated willingness to comply with all study procedures for the duration of the study, including lifestyle, activity, and sports restrictions
- •Provision of signed and dated informed consent form
排除标准
- •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:
- •Any prior ACL surgery on affected knee (except simple arthroscopy for plica, debris removal, or diagnosis)
- •Any prior ACL surgery on unaffected knee (except simple arthroscopy for plica, debris removal, diagnosis or partial meniscectomy)
- •Confirmed or suspected contralateral ACL tear
- •ACL tear found to be only partial and the treating physician feels it does not require surgery because it is "stable"
- •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
- •Diagnosis of Grade III medial collateral injury that requires concurrent or staged surgery
- •Insufficient ACL tissue on MRI
- •Diagnosis of complete patellar dislocation
- •Diagnosis of complete patellar tendon or quadriceps tear
- •Obesity with a BMI ≥45
- •Does not speak or understand English
- •Daily smoking (occasional or social use is accepted if smoking ≤ 3 days/ week and ≤ 5 cigarettes/day)
- •Documented history of illicit drug or alcohol abuse (except for recreational use of marijuana)
- •Inability to take oral medications
- •Use of intra-articular corticosteroids in the affected knee within last 6 months
- •Chronic use of corticosteroids for treatment of an autoimmune disorder such as lupus, rheumatoid arthritis, etc. (maintenance or rescue inhaler for asthma is allowed)
- •History of prior infection in knee
- •History of chemotherapy treatment
- •History of sickle cell disease
- •History of anaphylaxis, requiring a documented medical intervention
- •Any condition that, in the opinion of the investigator, could affect healing (e.g., diabetes, inflammatory arthritis, etc.)
- •Pregnancy or lactation
- •Known allergic reactions to meat products or collagen
- •Known allergy to bovine collagen, bovine gelatin, or other bovine products
- •Known adverse reaction to any bovine product
- •Febrile illness within 7 days
- •Treatment with another investigational drug or other intervention, either concurrently or previously, that would interfere with surgical healing
- •Not considered by treating physician to be a good research candidate
- •EXCLUSION CRITERIA AT INTRAOPERATIVE ARTHROSCOPIC EVALUATION
- •Time from injury to surgery has exceeded 50 days
- •No ACL tear found upon arthroscopic inspection
- •ACL tear found to be only partial, with normal pivot shift and endpoint, and does not require surgery
- •Displaced bucket handle meniscal injury requiring repair
- •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
- •Unrecognized lateral or medial sided Grade 3 ligamentous injury that requires concurrent or staged surgery
- •Tibial stump length is < 1cm
- •Tibial footprint attachment is < 50% intact
- •Any other reason the ACL stump should be deemed irreparable (e.g., tissue quality too poor to hold suture)
研究组 & 干预措施
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.
干预措施: ACL Reconstruction (Bone Patellar Tendon Bone Graft) (Procedure)
Bridge Enhanced ACL Restoration
Procedure/Surgery Bridge Enhanced ACL Restoration (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.
干预措施: Bridge Enhanced ACL Restoration (BEAR) (Device)
结局指标
主要结局
IKDC (International Knee Documentation Committee) Score
时间窗: 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).
KT-1000
时间窗: 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.
次要结局
- Quadriceps Strength Testing(Quadriceps Strength 2 years after surgery)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(Validated Patient Reported KOOS Subjective Score Instrument 2 years after surgery)
- MARX Activity (Marx Activity Rating Scale)(MARX Activity 2 years after surgery)
- Lachman Testing(Lachman Testing 2 years after surgery)
- Number of Participants with Treatment Failure(Treatment Failure 2 years after surgery)
- Anterior Knee Pain Scale (AKPS)(AKPS 2 years after surgery)
- Hop Test Limb Difference(Hop Test Limb Difference 2 years after surgery)
- Active Knee Range of Motion(Active Knee Range of Motion 2 years after surgery)
- Number of Participants with Knee Infection(Knee Infection 2 years after surgery)
研究者
Kurt Spindler, MD
Professor Surgery CCLCM Case Western, Director Research and Outcomes Cleveland Clinic Florida, Director Outcomes Management Evaluation, Co-Director Musculoskeletal Research Center
The Cleveland Clinic