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The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
NCT03348995 · View on ClinicalTrials.gov ↗
Study Summary
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Conditions Studied
Interventions
- DEVICE Bridge-Enhanced ACL Restoration (BEAR)
Study Locations (11)
California
- Scripps Health — San Diego
Florida
- Florida Orthopedic Institute — Tampa
Georgia
- Emory University School Of Medicine — Atlanta
Louisiana
- Ochsner Sports Medicine Institute — New Orleans
Maryland
- MedStar Health Surgery Center of Timonium — Lutherville
Massachusetts
- Boston Children's Hospital — Boston
New Jersey
- Virtua Health — Marlton
Rhode Island
- Cynthia Chrostek — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2034-04-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03348995
The ClinicalTrials.gov registry entry for NCT03348995 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Miach Orthopaedics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Anterior Cruciate Ligament Rupture appearing as the primary indexed condition, and to 1 intervention — of which Bridge-Enhanced ACL Restoration (BEAR) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03348995 reports 11 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03348995 about?
NCT03348995 is a clinical study titled "The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration". Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study ...
What is the current status of trial NCT03348995?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2018-04-17. Estimated completion is 2034-04-17.
What conditions does trial NCT03348995 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03348995?
The interventions under investigation include: Bridge-Enhanced ACL Restoration (BEAR) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03348995?
This trial is sponsored by Miach Orthopaedics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03348995 being conducted?
This trial has 11 study locations across California, Florida, Georgia, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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