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MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

NCT06289686 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-07

No results posted yet for this study

Summary

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

Conditions

  • Rotator Cuff Tears
  • Rotator Cuff Injuries
  • Surgery

Interventions

PROCEDURE

Rotator cuff repairs with BioEnthesis augmentation

Rotator cuff repair using BioEnthesis allograft patch

PROCEDURE

Rotator cuff repairs without BioEnthesis augmentation

Rotator cuff repair using standard of care sutures and anchors

Sponsors & Collaborators

  • Sparta Biopharma

    collaborator UNKNOWN

  • Musculoskeletal Injury Rehabilitation Research for Operational Readiness

    collaborator FED

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Jonathan Dickens, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289686 on ClinicalTrials.gov