Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

MiMedx

Status: Completed

Conditions: Supraspinatus Tear; Shoulder Sprain; Shoulder Injury

Treatments: Other: Placebo; Other: Human dehydrated umbilical cord allograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT03084068

ACORT001

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Human umbilical cord allograft

Experimental group

Description:

Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft

Treatment:

Other: Human dehydrated umbilical cord allograft

Placebo Control

Placebo Comparator group

Description:

Open Rotator Cuff Repair with standard suture repair

Treatment:

Other: Placebo