Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study

December 18, 2017 updated by: Applied Biologics, LLC

A Prospective, Randomized Study Comparing Outcomes Following Arthroscopic Double-row Rotator Cuff Repair With and Without the Addition of a Cryopreserved, Liquid, Injectable Amnion Allograft

Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction. A secondary injection will be administered at the time of repair in the supraspinatus muscle body medial to the musculotendonous junction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.

Detailed Description

Patients will be given a written explanation of the study and screened for inclusion and exclusion criteria. Included patients will have a repairable, full thickness rotator cuff tear limited to the supraspinatus and infraspinatus, confirmed by MRI. Patients with concomitant biceps tenotomy, tenodesis, arthroscopic subacromial decompression, and distal clavicle excision will be included. Patients with prior operations on the shoulder, partial thickness tears, subscapularis tears or labral tears requiring repair, irreparable supraspinatus tears, staged bilateral rotator cuff repairs, or concomitant suprascapular nerve decompression will be excluded. We will also exclude patients with co-morbid conditions requiring the use of corticosteroids. Patients who cannot have an MRI for medical reasons will also be excluded.

All participants will volunteer to enroll in the study by signing informed consent (Attachment B). All potential subjects will be over 18 years of age and capable of providing their own informed consent. Patients will be recruited from the patient populations of Dr. Edwards, Dr. Elkousy, Dr. Morris, Dr. Gombera and Dr Brown. The informed consent process will be conducted by the investigators, their staff, or their research associates (e.g., orthopedic surgery fellows), who will explain the purpose and methods of the study, the risks and benefits, and requirements of participation. Randomization to groups will occur following informed consent; patients will not know to which group they are assigned.

  1. Arthroscopic transosseous equivalent rotator cuff (TOE) repair will be performed; this is our standard procedure, using suture anchors in the medial and lateral rows for a TOE technique. The medial row will be 4.5 mm Polyether ether ketone (PEEK) anchors and the lateral row will be a 5.5 mm PEEK knotless anchor. Medial row anchor sutures will be tied.
  2. FlōGraft® details: 4cc of FlōGraft® will be used in each treated patient, provided in a single peel pouch containing two 2cc vials. In FlōGraft® treated patients, FlōGraft® will be applied, following repair as detailed below.

  3. FlōGraft® Preparation Protocol 3.1 Store FlōGraft® at -65◦C or colder until immediately prior to use. 3.2 Remove box from cold storage, open exterior box and remove interior package containing vials.

    3.3 Neither the interior dust cover nor the outside of the vial are sterile. Do not place either the interior package or the vial in sterile field.

    3.4 Remove vials from packaging, place on non-sterile, secure, flat surface, or hold vial firmly in one hand allowing contents to thaw (3-7 minutes.) Hold vial upright to aspirate contents. Note: Allograft should be implanted immediately post-thaw, but not later than eight (8) minutes post-thaw.

    3.5 Pierce the vial cap and draw thawed solution into syringe. Do not pressurize vial with air prior to extracting thawed FlōGraft® solution.

    3.6 If needed, change needle size based on surgeon preference (18g to 23g.)

  4. FlōGraft® Implantation 4.1 After the rotator cuff repair is completed, shut off water-flow to joint. Excess water in joint is drained through the skin incisions, creating a "dry" sub-acromial space.

    4.2 Insert needle through skin incision or percutaneously. Under direct visualization, inject FlōGraft® directly into rotator cuff tissue at repair site in approximately 0.50 cc aliquots. Cover entire repair site.

    4.3 Implant allograft into the cuff muscle more medially to the repair in 0.25-0.5 cc aliquots, as appropriate.

  5. Postoperative management: 4 weeks immobilization in abduction sling; passive range of motion will be initiated at the discretion of the surgeon based on tear size. Active range of motion will begin at 8 weeks to 16 weeks.
  6. Diagnostic MRI will be performed at one and two years postoperatively.

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 (Anticipated)

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.
260

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.
  • Not Applicable

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 Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Orthopedic Hospital
        • Contact:
        • Principal Investigator:
          • Hussein Elkousy, MD
        • Principal Investigator:
          • Bradley Edwards, MD
        • Sub-Investigator:
          • Brent Morris, MD
        • Sub-Investigator:
          • Mufaddal M Gombera, MD
        • Sub-Investigator:
          • Barrett S Brown, MD

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
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Included patients will have a repairable, full thickness rotator cuff tear limited to the supraspinatus and infraspinatus, confirmed by MRI. Patients with concomitant biceps tenotomy, tenodesis, arthroscopic subacromial decompression, and distal clavicle excision will be included.

Exclusion Criteria:

  • Patients with prior operations on the shoulder, partial thickness tears, subscapularis tears or labral tears requiring repair, irreparable supraspinatus tears, staged bilateral rotator cuff repairs, or concomitant suprascapular nerve decompression will be excluded. We will also exclude patients with co-morbid conditions requiring the use of corticosteroids. Patients who cannot have an MRI for medical reasons will also be excluded.

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
  • 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.
ACTIVE_COMPARATOR: Superiority of augmented repairs
Assess pain, function, and structural integrity of the rotator cuff at 3 months, 6 months, 1 year, and 2 years post-operation
Biological: Superiority of augmented repairs
4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
Other Names:
  • FlōGraft®
  • Human amniotic fluid-derived allograft
Biological: Fat degeneration of supraspinatus muscle
4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
Other Names:
  • FlōGraft®
  • Human amniotic fluid-derived allograft
ACTIVE_COMPARATOR: Fat degeneration of supraspinatus muscle
MRI assessment the quantity and disposition of fat within the supraspinatus muscle body compared to pre-operation MRI, at 1 year and 2 years post-operation
Biological: Superiority of augmented repairs
4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
Other Names:
  • FlōGraft®
  • Human amniotic fluid-derived allograft
Biological: Fat degeneration of supraspinatus muscle
4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
Other Names:
  • FlōGraft®
  • Human amniotic fluid-derived allograft

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
Structural healing integrity
Time Frame: 1 year post-operation
Improved structural healing is the best indication of long-term surgery success. The Sugaya grading system is a method to account for structural integrity of the rotator cuff following surgery with five possible classifications. Sugaya scale: type I indicating sufficient thickness with homogeneously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, the presence of a minor discontinuity; and type V, the presence of a major discontinuity. Types I-III indicate different levels of healing. The classification of each shoulder must be assessed using MRIs (grade determined by a blinded musculoskeletal radiologist).
1 year post-operation

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
Fatty degeneration
Time Frame: 1 year post-operation
Musculoskeletal radiologists will also evaluate fatty degeneration of the rotator cuff at 1 year post-operatively from the MRI using the Global Fatty Degeneration Index (GFDI).
1 year post-operation
Structural healing integrity (2)
Time Frame: 2 years post-operation
Improved structural healing is the best indication of long-term surgery success. The Sugaya grading system is a method to account for structural integrity of the rotator cuff following surgery with five possible classifications. Sugaya scale: type I indicating sufficient thickness with homogeneously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, the presence of a minor discontinuity; and type V, the presence of a major discontinuity. Types I-III indicate different levels of healing. The classification of each shoulder must be assessed using MRIs (grade determined by a blinded musculoskeletal radiologist).
2 years post-operation
Fatty degeneration (2)
Time Frame: 2 years post-operation
Musculoskeletal radiologists will also evaluate fatty degeneration of the rotator cuff at 2 years post-operatively from the MRI using the Global Fatty Degeneration Index (GFDI).
2 years post-operation
Functional outcome
Time Frame: Baseline
Functional outcomes will be assessed using the American Shoulder and Elbow Surgeons Score.
Baseline
Functional outcome (2)
Time Frame: 3 months post-operation
Functional outcomes will be assessed using the American Shoulder and Elbow Surgeons Score.
3 months post-operation
Functional outcome (3)
Time Frame: 6 months post-operation
Functional outcomes will be assessed using the American Shoulder and Elbow Surgeons Score.
6 months post-operation
Clinically Assessed Re-tear
Time Frame: 3 months post-operation
Any incidence of clinically assessed re-tear will be documented by the treating surgeon during routine postoperative follow-up clinic visits and examinations.
3 months post-operation
Clinically Assessed Re-tear (2)
Time Frame: 6 months post-operation
Any incidence of clinically assessed re-tear will be documented by the treating surgeon during routine postoperative follow-up clinic visits and examinations.
6 months post-operation

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.
Applied Biologics, LLC

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.
Fondren Orthopedic Group L.L.P.
Texas Orthopedic Hospital

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.
  • Study Chair: Gregory Stocks, MD, Texas Orthopedic Hospital

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 (ACTUAL)

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.
March 24, 2017

Primary Completion (ANTICIPATED)

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.
September 30, 2019

Study Completion (ANTICIPATED)

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.
September 30, 2019

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).
November 20, 2017

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.
December 18, 2017

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.
December 20, 2017

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.
December 20, 2017

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.
December 18, 2017

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.
December 1, 2017

More Information

Terms related to this study

Keywords

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.
  • TOH169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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