Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

Shoulder Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084068
• Other study ID #: ACORT001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: December 2019
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Injuries
• Shoulder Injury
• Shoulder Sprain
• Supraspinatus Tear

Intervention

Other:
• Human dehydrated umbilical cord allograft
human dehydrated umbilical cord allograft
• Placebo
Open rotator cuff surgery with standard suture repair

Locations

Country	Name	City	State
United States	Hand & UpperEx Center	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASES score	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.	12 months
Secondary	Constant Murley Score	Comparison of Constant scores between the two groups at each study time point	12 months
Secondary	Shoulder range of motion	Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.	12 months
Secondary	VAS Pain scores	Change in patient reported pain from baseline	12 months
Secondary	Incidence of tendon re-tear	Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists	12 months
Secondary	Incidence of adverse events	Incidence of adverse events	12 months