Clinical trial NCT03084068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injury
Shoulder Sprain
Supraspinatus Tear
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ASES score
timeFrame: 12 months
Secondary outcomes:
measure: Constant Murley Score
timeFrame: 12 months
measure: Shoulder range of motion
timeFrame: 12 months
measure: VAS Pain scores
timeFrame: 12 months
measure: Incidence of tendon re-tear
timeFrame: 12 months
measure: Incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Wexford
country: United States
facility: Hand & UpperEx Center
state: Pennsylvania
Study officials:
affiliation: MiMedx Group, Inc.
name: David Mason, MD
role: STUDY_DIRECTOR
References: