# BEAR-MOON: A Two Arm Noninferiority Blinded Randomized Clinical Trial Comparing ACL Repair with BEAR Device vs. Standard of Care Autograft Patellar Tendon ACL Reconstruction

> **NIH NIH R01** · CLEVELAND CLINIC LERNER COM-CWRU · 2021 · $1,135,668

## Abstract

PROJECT SUMMARY
Tissues which live within joints, including the anterior cruciate ligament, rotator cuff tendon, meniscus and
labrum fail to heal spontaneously after injury and have high failure rates of surgical repair. The ACL represents
a good model to study the problem of intra-articular healing as there are validated preclinical models and
clinical outcome measures that make it possible to critically evaluate the success or failure of strategies to
enhance tissue healing. The current standard of care for ACL injuries is ACL reconstruction, which is good at
stabilizing the knee but requires compromising other uninjured structures around the knee to obtain a graft that
is subsequently used to replace the ACL. Further the early posttraumatic OA is not mitigated despite ACL
reconstruction. The preclinical studies on ACL repair called BEAR (Bridge-Enhanced ACL Repair)
demonstrated a prevention of posttraumatic OA and achieved knee stability. The positive preclinical findings of
BEAR compared to ACL reconstruction provided the foundation for two FDA approved preliminary clinical
trials: 1) the first-in-human cohort study (“BEAR I”), and 2) a small, single-center randomized control trial
(“BEAR II”). The statistical analysis of our pilot data shows a 200 patient trial will be required to demonstrate
non-inferiority of BEAR (a novel paradigm changing technology) when compared to ACL reconstruction
(current gold standard) for the key outcomes of anterior-posterior (AP) knee laxity and a validated patient
reported outcome for knee surgery. Therefore we propose the BEAR-MOON (Bridge-Enhanced ACL Repair)
multi-center randomized non-inferiority clinical trial for co-primary outcomes AP (anterior-posterior) knee laxity
and International Knee Documentation Committee (IKDC) validated patient reported outcome measure. The
subjects will be between 18 and 40 years of age with a complete ACL tear and randomized to either 1) ACL
Reconstruction with patellar tendon autograft (ACLR) or 2) Bridge-Enhanced ACL Repair (BEAR). We will
follow subjects at 6 months, 1 and 2 years after surgery. While achieving these aims has the potential to
change the clinical practice of ACL surgery, the impact is potentially far greater, as the availability of an FDA-
approved carrier that can be used to deliver complex biologic therapies to tissues within joints could enable the
clinical translation of the preclinical studies being conducted in multiple areas of regenerative medicine by
providing a delivery vehicle for these therapies.

## Key facts

- **NIH application ID:** 9986663
- **Project number:** 5R01AR074131-03
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** Kurt Paul Spindler
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,135,668
- **Award type:** 5
- **Project period:** 2018-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986663

## Citation

> US National Institutes of Health, RePORTER application 9986663, BEAR-MOON: A Two Arm Noninferiority Blinded Randomized Clinical Trial Comparing ACL Repair with BEAR Device vs. Standard of Care Autograft Patellar Tendon ACL Reconstruction (5R01AR074131-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9986663. Licensed CC0.

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