BEAR Device vs. Autograft for ACL Tear

(BEAR-MOON Trial)

Not currently recruiting at 5 trial locations

Overseen By Carrie B Melgaard, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Corticosteroids

Disqualifiers: Obesity, Smoking, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for repairing torn ACLs, a key ligament in the knee. One method uses the standard approach, replacing the ACL with part of the patellar tendon. The other method, a newer technique called BEAR (Bridge Enhanced ACL Repair), uses a special implant to help the ACL heal itself. The trial aims to determine if the BEAR method is as effective as the standard surgery while being less invasive. Suitable participants have a complete ACL tear confirmed by MRI and plan to undergo surgery within 50 days of their injury. As an unphased trial, this study offers patients the chance to explore innovative surgical options that could improve recovery outcomes.

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 prior data suggests that the BEAR device is safe for ACL repair?

Research has shown that the BEAR technique, which uses a special sponge implant to heal a torn ACL, is generally well-tolerated. In a study of over 100 patients who underwent the BEAR procedure, researchers found it to be safe, with no unexpected problems reported a year after surgery. Another study indicates that recovery results from BEAR are similar to those from traditional ACL surgery methods, such as using hamstring tendon grafts, even after six years.

This is promising because BEAR differs from the traditional bone to patellar tendon to bone (BPTB) surgery. BPTB involves removing part of the patellar tendon to repair the ACL, which can be more invasive. The BEAR technique skips this step, potentially leading to less pain and faster recovery. With FDA approval of the BEAR implant, there is added confidence in its safety for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bridge Enhanced ACL Restoration (BEAR) technique because it offers a new way to heal torn ACLs. Unlike the standard ACL reconstruction using a bone-patellar tendon-bone graft, BEAR involves placing a special sponge between the torn ends of the ACL. This sponge acts as a bridge, encouraging the ligament to naturally regrow and heal. This innovative approach could potentially reduce the need for tissue grafts and promote more natural healing, making it a promising option for ACL tears.

What evidence suggests that this trial's treatments could be effective for ACL tears?

Research shows that the Bridge-Enhanced ACL Repair (BEAR) technique, one of the treatments studied in this trial, holds promise for fixing ACL tears. Studies have found that BEAR can achieve results similar to traditional ACL surgery, such as the bone to patellar tendon to bone autograft (BPTB), which is the other treatment arm in this trial, even six years after the procedure. Some research also suggests that BEAR might lead to better hamstring strength two years post-surgery. Additionally, patients undergoing BEAR tend to experience fewer tears in the opposite knee compared to those who have other types of surgery. Overall, BEAR appears to be a strong alternative to traditional ACL surgery, with the potential for quicker recovery and less invasive procedures. ^{1 2 5 6 7}

Who Is on the Research Team?

Kurt Spindler, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ACL Reconstruction (Bone Patellar Tendon Bone Graft)
• Bridge Enhanced ACL Repair (BEAR)
• Bridge Enhanced ACL Restoration (BEAR)

Trial Overview 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.

How Is the Trial Designed?

Group I: Bridge Enhanced ACL Restoration Experimental Treatment 1 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 Control 1 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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Miach Orthopaedics

Industry Sponsor

Trials

5

Recruited

1,300+

Published Research Related to This Trial

A new surgical technique using bone-patellar tendon-bone (BTB) grafts for remnant-preserving, selective-bundle ACL augmentation was developed and tested in five young male patients, showing promising results without bone tunnel enlargement.

This method may provide a durable reconstruction option for patients with partial ACL tears, indicating its potential effectiveness in maintaining knee stability and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remnant-preserving, selective single-bundle augmentation of the anterior cruciate ligament using a bone-patellar tendon-bone autograft: A technical note. Tajima, T., Chosa, E., Yamaguchi, N., et al.[2022]

In the short term (up to 2 years), the bone-patellar tendon-bone (BPTB) autograft showed better knee stability compared to the four-strand hamstring tendon (4S-HT) autograft, as indicated by lower knee laxity and better pivot-shift test results in a meta-analysis of 23 randomized controlled trials involving 933 participants.

However, in the mid-term (3-5 years), the 4S-HT group demonstrated better objective knee function, while the BPTB group had more donor-site complications, such as anterior knee pain and extension deficits, suggesting that while BPTB may provide better short-term stability, it may lead to more long-term issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. He, X., Yang, XG., Feng, JT., et al.[2022]

In a meta-analysis of 6 studies involving 534 patients, BPTB autograft showed a significantly lower risk of graft rupture compared to BPTB allograft, with an odds ratio of 5.03, indicating that allograft patients were more likely to experience graft failure.

When excluding irradiated and chemically processed grafts, there were no significant differences in outcomes between autograft and allograft, suggesting that the processing of grafts may influence the results of ACL reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction. Krych, AJ., Jackson, JD., Hoskin, TL., et al.[2022]

The use of bone-patella tendon-bone (BPTB) autograft is highlighted as a gold standard technique for anterior cruciate ligament reconstruction (ACLR), emphasizing its established efficacy in surgical outcomes.

This Technical Note details a specific method of ACLR that employs press-fit femoral fixation with an outside-in drilling technique, which may enhance the stability and integration of the graft.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction Using Bone-Patella Tendon-Bone Autograft With Press-Fit Femoral Fixation: The Original Chambat Technique. Levy, Y., Gousopoulos, L., Hopper, GP., et al.[2022]

In a study of 121 patients undergoing ACL reconstruction, the addition of a lateral extra-articular tenodesis (LET) did not significantly improve long-term patient-reported outcomes compared to isolated ACL reconstruction with a bone-patellar tendon-bone graft.

However, the group that received LET showed a higher incidence of lateral compartment osteoarthritis (59% vs. 22%), suggesting that while LET may help with graft stability, it could also increase the risk of joint degeneration in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Castoldi, M., Magnussen, RA., Gunst, S., et al.[2020]

In a study of 21 patients undergoing ACL reconstruction with a modified bone-patellar-tendon-bone (BPTB) autograft technique, there was no evidence of graft slippage or displacement within the first 3 months post-surgery, indicating strong fixation stability.

Radiological assessments showed that 90% of patients achieved bony incorporation of the graft to the tunnel wall, suggesting effective healing and integration of the graft with minimal bone resorption at the harvest site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined press-fit and extracortical fixation in patellar tendon anterior cruciate ligament reconstruction results in reliable graft fixation and early bone block incorporation. Feichtinger, X., Muji, E., Domej, MA., et al.[2023]

A systematic review of 4 randomized controlled trials involving 221 patients found no significant differences in clinical outcomes or knee pain between ACL reconstruction patients who had their patellar tendon defect closed versus those who did not.

The overall quality of the studies was low, which limits the reliability of the findings, as indicated by poor scores on the Modified Coleman Methodology Score and the Jadad scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of patellar tendon defect in anterior cruciate ligament reconstruction with bone-patellar tendon-bone autograft: systematic review of randomized controlled trials. Frank, RM., Mascarenhas, R., Haro, M., et al.[2022]

In a study of 107 patients aged 18 to 25, a majority (63.6%) preferred bone-patellar tendon-bone (BTB) grafts over hamstring grafts for ACL reconstruction, indicating a significant preference among young athletes for BTB due to its perceived benefits.

Patients who preferred BTB rated the importance of returning to sport and the risk of additional surgery due to graft failure higher than those who preferred hamstring grafts, while they were less concerned about knee pain and complication risks, highlighting the need to consider patient values in surgical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Decision Making in Anterior Cruciate Ligament Reconstruction: A Discrete Choice Experiment Examining Graft Preference. Sonnier, JH., Paul, RW., Sando, HE., et al.[2023]

In a study of 1009 matched patients followed for an average of over 8 years, those who had combined ACL reconstruction with anterolateral ligament reconstruction using hamstring tendon autografts had significantly lower rates of graft failure compared to those who had isolated ACL reconstruction with bone-patellar tendon-bone autografts.

Patients under 20 years old were particularly at risk, with a more than five-fold increase in graft ruptures compared to older patients, highlighting the importance of age in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Pioger, C., Gousopoulos, L., Hopper, GP., et al.[2022]

In a study of 285 patients who underwent arthroscopic ACL reconstruction using bone patellar tendon bone grafts, the incidence of heterotopic ossification at the femoral tunnel site was found to be low, at 2.58% without preventive measures.

Implementing preventive measures significantly reduced the incidence of heterotopic ossification to 1.54%, indicating that such measures are effective in minimizing this rare complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To study the incidence of heterotopic ossification after anterior cruciate ligament reconstruction. Bhandary, B., Shetty, S., Bangera, VV., et al.[2021]

A meta-analysis of 29 studies involving 3099 patients found no significant difference in the ability to return to preinjury levels of sports between patients who received bone-patellar tendon-bone (BPTB) and hamstring tendon (HT) autografts for ACL reconstruction, with a risk ratio of 1.03 (P = .63).

However, BPTB autografts showed a statistically significant advantage in knee stability, as indicated by a lower risk ratio of 0.66 for a positive pivot-shift test (P = .002), suggesting better knee stability outcomes with BPTB grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bergeron, JJ., Sercia, QP., Drager, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11322937/

Bridge-Enhanced Anterior Cruciate Ligament Restoration This preliminary study suggests that the outcomes of BEAR and ACLR with a hamstring tendon graft may be similar at the 6-year follow-up.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965036/

Indications, Techniques, and Outcomes of Bridge-Enhanced ... Current research demonstrates similar postoperative patient-reported outcome measures and functional outcomes following BEAR compared to ACL ...

3. miachortho.com miachortho.com/healthcare-professionals/clinical-evidence/

Clinical Evidence BEAR Implant patients experience a trend toward fewer contralateral ACL tears at 2 years. Contralateral ACL tears outcome data. Skier ...

4. sicot-j.org sicot-j.org/articles/sicotj/full_html/2023/01/sicotj230014/sicotj230014.html

Bridge enhanced ACL repair vs. ACL reconstruction for ... The results showed that when compared to ACLR, BEAR had a significantly better hamstring strength 2 years postoperatively. (p < 0.00001, mean ...

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00143-9/fulltext

Modified Bridge-Enhanced Anterior Cruciate Ligament ... The short-term results of this procedure are promising, showing noninferiority to traditional ACL reconstruction at 2 years postoperatively and ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200035.pdf

BEAR® (Bridge-Enhanced ACL Repair) Implant A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically ...

7. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/ksa.12806

Postcommercialisation outcomes of bridge‐enhanced anterior ... Purpose To review adverse events and outcomes at least 1 year postoperatively from Bridge enhanced ACL restoration (BEAR) in the first 100 ...