BEAR Device vs. Autograft for ACL Tear
(BEAR-MOON Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Must not be taking: Corticosteroids
Disqualifiers: Obesity, Smoking, Drug abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing BEAR, a new knee surgery method using a sponge to help a torn ligament heal. It targets patients aged 18-55 who need ACL surgery. The sponge helps the torn ligament ends grow back together naturally. BEAR has shown promising results in early studies, suggesting it may be a viable alternative to traditional ACL reconstruction methods.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using corticosteroids or have been treated with intra-articular corticosteroids in the affected knee within the last 6 months, you may not be eligible to participate.
What data supports the effectiveness of the treatment BEAR Device vs. Autograft for ACL Tear?
Research shows that using a bone-patellar tendon-bone (BPTB) autograft for ACL reconstruction is considered a reliable method with good long-term success rates. This technique is known for its strong graft fixation and early bone healing, which are important for effective ACL repair.
12345Is the BEAR Device vs. Autograft for ACL Tear safe for humans?
The studies reviewed focus on the safety and effectiveness of bone-patellar tendon-bone (BPTB) autografts for ACL reconstruction, which is a common and generally safe procedure for repairing ACL tears. However, specific safety data for the BEAR device is not provided in these studies.
16789What makes the BEAR Device treatment for ACL tears unique compared to other treatments?
The BEAR Device treatment for ACL tears is unique because it uses a special implant to encourage the body to heal the torn ligament naturally, rather than replacing it with a graft from another part of the body, which is common in traditional ACL reconstruction methods.
1371011Eligibility Criteria
This trial is for individuals aged 18-55 who have a complete ACL tear confirmed by MRI and are within 50 days of their injury. They must be considered candidates for ACL surgery, agree to follow study procedures including activity restrictions, and provide informed consent.Inclusion Criteria
My surgery is within 50 days of my injury.
Complete ACL tear as confirmed by MRI
I have chosen surgery for my ACL injury.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery and Initial Recovery
Participants undergo ACL surgery using either the BEAR device or BPTB reconstruction, followed by initial recovery
4-8 weeks
Rehabilitation
Participants follow specified rehabilitation protocols post-operatively
6 months
Follow-up
Participants are monitored for safety and effectiveness with assessments at 6 months, 1 year, and 2 years
2 years
Participant Groups
The study compares two surgical techniques for repairing torn ACLs: the new BEAR method using a blood-enriched implant to promote healing, versus the traditional BPTB reconstruction that uses transplanted patellar tendon tissue.
2Treatment groups
Experimental Treatment
Active Control
Group I: Bridge Enhanced ACL RestorationExperimental Treatment1 Intervention
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.
Group II: ACL Reconstruction(BPTB Graft)Active Control1 Intervention
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.
ACL Reconstruction (Bone Patellar Tendon Bone Graft) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Bone Patellar Tendon Bone Graft for:
- Anterior Cruciate Ligament (ACL) reconstruction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ColoradoBoulder, CO
University Orthopedics Institute/ Rhode Island HospitalProvidence, RI
Cleveland ClinicCleveland, OH
Ohio State UniversityColumbus, OH
More Trial Locations
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
Miach OrthopaedicsIndustry Sponsor
References
Combined press-fit and extracortical fixation in patellar tendon anterior cruciate ligament reconstruction results in reliable graft fixation and early bone block incorporation. [2023]Anterior cruciate ligament (ACL) reconstruction with bone-patellar-tendon-bone (BPTB) autograft has the potential biological advantage of direct bone-to-bone healing over soft tissue grafts. The primary aim of this study was to investigate possible graft slippage and therefore fixation strength in a modified BPTB autograft technique with suspensory fixation on both sides for primary ACL reconstruction until bony integration takes place.
Anterior Cruciate Ligament Reconstruction Using Bone-Patella Tendon-Bone Autograft With Press-Fit Femoral Fixation: The Original Chambat Technique. [2022]Patellar tendon grafts have long been considered the gold standard for anterior cruciate ligament reconstruction (ACLR). This Technical Note describes ACLR using bone-patella tendon-bone (BPTB) autograft with press-fit femoral fixation using an outside-in drilling technique.
Clinical Outcomes After Combined ACL and Anterolateral Ligament Reconstruction Versus Isolated ACL Reconstruction With Bone-Patellar Tendon-Bone Grafts: A Matched-Pair Analysis of 2018 Patients From the SANTI Study Group. [2022]Bone-patellar tendon-bone (BPTB) autografts are widely considered the standard for anterior cruciate ligament reconstruction (ACLR).
To study the incidence of heterotopic ossification after anterior cruciate ligament reconstruction. [2021]Previous studies have enumerated the advantages of an arthroscopic Anterior Cruciate Ligament (ACL) reconstruction with the use of a Bone Patellar Tendon Bone (BPTB) graft. Complications are extremely rare in such surgeries and one such known complication, which is an extra-articular heterotophic ossification at the femoral tunnel site, is rarely seen only in few patients.
A meta-analysis of patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction. [2022]Studies have suggested good long-term success rates with bone-patellar tendon-bone (BPTB) autograft and BPTB allograft in anterior cruciate ligament (ACL) reconstruction, but the numbers reported in available prospective studies may be underpowered to elucidate significant differences between the two groups. Here, we present a meta-analysis to compare the results of BPTB autograft and BPTB allograft in primary ACL reconstruction.
Remnant-preserving, selective single-bundle augmentation of the anterior cruciate ligament using a bone-patellar tendon-bone autograft: A technical note. [2022]To the best of our knowledge, there has been no detailed study on bone-patellar tendon-bone (BTB) grafts for remnant-preserving, selective-bundle anterior cruciate ligament (ACL) augmentation. Therefore, we aimed to develop such a technique using a BTB graft.
Clinical Outcomes of the Central Third Patellar Tendon Versus Four-strand Hamstring Tendon Autograft Used for Anterior Cruciate Ligament Reconstruction: A Systematic Review and Subgroup Meta-analysis of Randomized Controlled Trials. [2022]The most frequently used auto-grafts for ACL reconstruction (ACLR) are bone-patellar tendon-bone (BPTB) and four-strand hamstring tendon (4S-HT), but significant controversy exists about which graft is better. This study aimed to compare the knee outcomes following ACLR with BPTB and 4S-HT autografts.
A Randomized Controlled Trial of Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis: 19-Year Clinical and Radiological Follow-up. [2020]Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB) is a reliable surgical option for the control of anterior knee laxity after ACL injury. The addition of a lateral extra-articular tenodesis (LET) may improve control of rotation knee laxity and improve short-term graft survival in high-risk patients.
Closure of patellar tendon defect in anterior cruciate ligament reconstruction with bone-patellar tendon-bone autograft: systematic review of randomized controlled trials. [2022]This study aimed to systematically review the highest level of evidence on anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autografts with patellar tendon defect closure versus no closure after surgery.
Return to Baseline Physical Activity After Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]Bone-patellar tendon-bone (BPTB) and hamstring tendon (HT) autografts are the most utilized grafts for primary anterior cruciate ligament (ACL) reconstruction. The ability of a patient to return to a preinjury level of physical activity is a key consideration in choice of graft; the influence of graft choice on this metric lacks consensus in the literature.
Patient Decision Making in Anterior Cruciate Ligament Reconstruction: A Discrete Choice Experiment Examining Graft Preference. [2023]Bone-patellar tendon-bone (BTB) and hamstring autografts are the most common grafts used for anterior cruciate ligament (ACL) reconstruction. Patient preferences should be accounted for as a part of shared decision making.