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

June 5, 2024 updated by: Dr. Andrew Sheean, Brooke Army Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
    • Texas
      • San Antonio, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • DEERS-eligible
  • Adults, between the ages of 18-65 (inclusive)
  • Presenting with a rotator cuff tear that is reparable surgically (a reparable tear is defined as tear of the RC where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension)
  • Ability to undergo surgery to repair rotator cuff tear
  • Willingness to commit to study procedures including study intervention and a 12-month follow-up
  • Fluency in speaking, reading, comprehending English
  • 1-2 tendon full thickness reparable RC tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border)

Exclusion Criteria:

  • Previous shoulder surgery (excluding acromioplasty or diagnostic arthroscopy)
  • Inability to receive an MRI
  • Current (within the past 6 months) tobacco user
  • Unwilling to remain tobacco free for the duration of the study
  • Current lower limb injuries requiring walking assist devices such as crutches and walkers
  • Diagnosed with systemic arthritis
  • Significant neck pathology
  • Active joint or systemic infection
  • Currently enrolled, or plans to enroll, in another clinical trial during this study (that would affect the patient's safety or results of this trial)
  • Significant muscle paralysis of the shoulder girdle
  • Currently pregnant or plans to become pregnant during this study
  • Inability of the surgeon to repair the tear with remaining defect no greater than 10 mm in diameter
  • Inability of the surgeon to repair the tear with less than 1cm of medialization
  • Evidence of other significant shoulder pathology including Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis.
  • Has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
  • Major medical illness that would preclude undergoing surgery
  • Major psychiatric illness or developmental handicap
  • Goutallier III classification and above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BioEnthesis
Allogenic, acellular, biphasic allograft (BioEnthesis)
Procedure: Rotator cuff repairs with BioEnthesis augmentation
Rotator cuff repair using BioEnthesis allograft patch
Active Comparator: Standard of Care
Standard rotator cuff repair (suture and anchor based technique)
Procedure: Rotator cuff repairs without BioEnthesis augmentation
Rotator cuff repair using standard of care sutures and anchors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of re-tear
Time Frame: Post-operation at 3-months, 6-months, and 12-months
Re-tear rates following rotator cuff repair using BioEnthesis versus standard of care. Assessed with (1) 12-month follow-up shoulder MRI and assigning Sugaya Classification, and (2) adverse events evaluation at each follow-up timepoint
Post-operation at 3-months, 6-months, and 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Visual Analogue Scale (VAS) from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
Change in the return to activities of daily living (ADL) from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
A survey asking patients if and when patients have returned to various activities of daily living, such as work, driving, physical/recreational activities.
Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
Change in the Concomitant medications (ConMeds) from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
A survey asking patients to indicate any medications they are taking at the time of the survey (e.g., Acetaminophen, opioids, NSAIDs, etc.)
Pre-operation (baseline) and then post-operation at 3-months, 6-months, and 12-months
Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
The SANE score is a validated patient reported outcome measure. It is a single question score that asks, "how would you rate your condition today as a percentage of normal (0% to 100% scale with 100% being normal)?" The SANE score is collected as standard of care.
Pre-operation (baseline) and then post-operation at 6-months, and 12-months
Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points
Pre-operation (baseline) and then post-operation at 6-months, and 12-months
Change in the Constant-Murley Score from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 6-months, and 12-months
The Constant-Murley Score is a multi-item functional scale assessing pain, activities of daily living, range of motion, and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.
Pre-operation (baseline) and then post-operation at 6-months, and 12-months
Change in the shoulder immobilization status from before surgery to after surgery
Time Frame: Post-operation at 3-months, 6-months, and 12-months
A survey asking patients to indicate if they wore a sling after their surgery and for how long they wore their sling.
Post-operation at 3-months, 6-months, and 12-months
Change in strength measurements from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
Strength measurements will be collected using a handheld dynamometer while the arm is in two positions: (1) abduction with the arm in the scapular plane, and (2) external rotation while the arm is adducted and the elbow is flexed to 90 degrees
Pre-operation (baseline) and then post-operation at 6-months and 12-months
Change in range of motion measurements from before surgery to after surgery
Time Frame: Pre-operation (baseline) and then post-operation at 6-months and 12-months
Range of motion measurements will be collected using a goniometer while the arm moves through four movements: (1) forward flexion, (2) abduction, (3) external rotation, and (4) internal rotation
Pre-operation (baseline) and then post-operation at 6-months and 12-months
Number of medical events/adverse events after surgery
Time Frame: Day of surgery and post-operation at 3-months, 6-months, and 12-months
A count of the number of post-operative medical/adverse events for the affected shoulder after the patient's surgery.
Day of surgery and post-operation at 3-months, 6-months, and 12-months
Cumulative number of steroid injections after surgery
Time Frame: Post-operation at 3-months, 6-months, and 12-months
A count of the number of post-operative steroid injections obtained for the affected shoulder after the patient's surgery.
Post-operation at 3-months, 6-months, and 12-months
Number of unscheduled visits after surgery
Time Frame: Post-operation at 3-months, 6-months, and 12-months
A count of the number of clinic visits outside the typical standard of care visits for the affected shoulder after the patient's surgery.
Post-operation at 3-months, 6-months, and 12-months
Number of for-cause imaging procedures
Time Frame: Post-operation at 3-months, 6-months, and 12-months
A count of the number of radiographic imaging obtained, and the type of imaging obtained, for the affected shoulder after the patient's surgery.
Post-operation at 3-months, 6-months, and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brooke Army Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Sparta Biopharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Dickens, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C.2023.080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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