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Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

Primary Purpose

Shoulder Injury, Shoulder Sprain, Supraspinatus Tear

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Human dehydrated umbilical cord allograft

Placebo

About this trial

This is an interventional treatment trial for Shoulder Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
Subject is male or female age 18 or older
Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

Subjects who meet ANY of the following criteria will be excluded from the study:

Shoulder pain primarily attributed to any of the following:
1. Ligament rupture due to use of fluoroquinolones
2. Capsular tear
3. Fracture of the humeral head
4. Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis)
5. Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve
6. Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus)
Known history of poor compliance with medical treatments
Subject has bilateral supraspinatus tendon tear
Subject has signs and symptoms of an active infection of the shoulder joint
Retraction of the supraspinatus tendon exceeding 1.5 cm in length
Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
Subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than Rotator Cuff Repair in the target arm within 180 days of treatment
Subjects currently receiving radiation therapy or chemotherapy
Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
Workers' compensation patients

Sites / Locations

Hand & UpperEx Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Human umbilical cord allograft

Placebo Control

Arm Description

Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft

Open Rotator Cuff Repair with standard suture repair

Outcomes

Primary Outcome Measures

ASES score

The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.

Secondary Outcome Measures

Constant Murley Score

Comparison of Constant scores between the two groups at each study time point

Shoulder range of motion

Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.

VAS Pain scores

Change in patient reported pain from baseline

Incidence of tendon re-tear

Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists

Incidence of adverse events

Full Information

NCT ID

NCT03084068

First Posted

March 14, 2017

Last Updated

December 17, 2019

Sponsor

MiMedx Group, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03084068

Brief Title

Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

Official Title

A Prospective, Randomized Controlled Trial for Rotator Cuff Repair - Efficacy of Supraspinatus Tendon Repair Using a Human Dehydrated Umbilical Cord Patch

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

January 17, 2019 (Actual)

Study Completion Date

January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MiMedx Group, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Injury, Shoulder Sprain, Supraspinatus Tear

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Human umbilical cord allograft

Arm Type

Experimental

Arm Description

Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft

Arm Title

Placebo Control

Arm Type

Placebo Comparator

Arm Description

Open Rotator Cuff Repair with standard suture repair

Intervention Type

Other

Intervention Name(s)

Human dehydrated umbilical cord allograft

Intervention Description

human dehydrated umbilical cord allograft

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Open rotator cuff surgery with standard suture repair

Primary Outcome Measure Information:

Title

ASES score

Description

The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Constant Murley Score

Description

Comparison of Constant scores between the two groups at each study time point

Time Frame

12 months

Title

Shoulder range of motion

Description

Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.

Time Frame

12 months

Title

VAS Pain scores

Description

Change in patient reported pain from baseline

Time Frame

12 months

Title

Incidence of tendon re-tear

Description

Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists

Time Frame

12 months

Title

Incidence of adverse events

Description

Incidence of adverse events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair) Subject is male or female age 18 or older Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study Exclusion Criteria: Subjects who meet ANY of the following criteria will be excluded from the study: Shoulder pain primarily attributed to any of the following: Ligament rupture due to use of fluoroquinolones Capsular tear Fracture of the humeral head Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis) Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus) Known history of poor compliance with medical treatments Subject has bilateral supraspinatus tendon tear Subject has signs and symptoms of an active infection of the shoulder joint Retraction of the supraspinatus tendon exceeding 1.5 cm in length Subject has additional injuries requiring further surgical intervention to the ipsilateral arm Subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than Rotator Cuff Repair in the target arm within 180 days of treatment Subjects currently receiving radiation therapy or chemotherapy Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate Workers' compensation patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Mason, MD

Organizational Affiliation

MiMedx Group, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Hand & UpperEx Center

City

Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

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