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Completed

NCT Number: NCT03084068

Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

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.

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Key information

Conditions

Shoulder Injury Shoulder Injuries Shoulder Sprain Supraspinatus Tear Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hand & UpperEx Center

Wexford, Pennsylvania, 15090, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human dehydrated umbilical cord allograft

Other

human dehydrated umbilical cord allograft

Placebo

Other

Open rotator cuff surgery with standard suture repair

Primary outcomes

  1. ASES score

    Time frame: 12 months

    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 outcomes

  1. Constant Murley Score

    Time frame: 12 months

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

  2. Shoulder range of motion

    Time frame: 12 months

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

  3. VAS Pain scores

    Time frame: 12 months

    Change in patient reported pain from baseline

  4. Incidence of tendon re-tear

    Time frame: 12 months

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

  5. Incidence of adverse events

    Time frame: 12 months

    Incidence of adverse events

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2017
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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