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Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

NCT ID: NCT03084068

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-01-17

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Injury Shoulder Sprain Supraspinatus Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Human umbilical cord allograft

Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft

Group Type EXPERIMENTAL

Human dehydrated umbilical cord allograft

Intervention Type OTHER

human dehydrated umbilical cord allograft

Placebo Control

Open Rotator Cuff Repair with standard suture repair

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Open rotator cuff surgery with standard suture repair

Interventions

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Human dehydrated umbilical cord allograft

human dehydrated umbilical cord allograft

Intervention Type OTHER

Placebo

Open rotator cuff surgery with standard suture repair

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
2. Subject is male or female age 18 or older
3. 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:

1. 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)
2. Known history of poor compliance with medical treatments
3. Subject has bilateral supraspinatus tendon tear
4. Subject has signs and symptoms of an active infection of the shoulder joint
5. Retraction of the supraspinatus tendon exceeding 1.5 cm in length
6. Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
7. 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
8. Subjects currently receiving radiation therapy or chemotherapy
9. Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
10. Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
11. Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
12. Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
13. Workers' compensation patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MiMedx Group, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Mason, MD

Role: STUDY_DIRECTOR

MiMedx Group, Inc.

Locations

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Hand & UpperEx Center

Wexford, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ACORT001

Identifier Type: -

Identifier Source: org_study_id