Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

Not Applicable

Completed

• Conditions: Shoulder Sprain; Supraspinatus Tear; Shoulder Injury
• Interventions: Other: Placebo; Other: Human dehydrated umbilical cord allograft

• Registration Number: NCT03084068
• Lead Sponsor: MiMedx Group, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Placebo	Open Rotator Cuff Repair with standard suture repair
Human umbilical cord allograft	Human dehydrated umbilical cord allograft	Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft

Primary Outcome Measures

Name	Time	Method
ASES score	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 Outcome Measures

Name	Time	Method
Constant Murley Score	12 months	Comparison of Constant scores between the two groups at each study time point
Shoulder range of motion	12 months	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	12 months	Change in patient reported pain from baseline
Incidence of tendon re-tear	12 months	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	12 months	Incidence of adverse events

Trial Locations

Locations (1)

Hand & UpperEx Center; 🇺🇸 Wexford, Pennsylvania, United States