Clinical trial NCT04588506: Tendon Transfer Rotator Cuff Tear
Official title: Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs: An Integrated Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Massive Rotator Cuff Tears
Tendon Transfer
Rotator Cuff Tears
Tendon Transfer Techniques
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder. There are 3 muscles covering the shoulder joint- supraspinatus, infraspinatus and subscapularis. Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques. These muscle tendons may be from the lower back (Latissimus Dorsi), upper pack (lower trapezius) or chest (pectoralis). There are currently no studies to show which tendon transfer technique has better outcomes.

This study comprises two trials and a total of 84 participants would be enrolled. Each trial comparing the patient reported outcomes between two tendon transfer techniques. Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique. 21 patients would be randomly assigned to either groups. The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle. Another 21 patients would be randomly assigned to either groups.

The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique.

For both trials, participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups.


Eligibility criteria: Inclusion Criteria:

* Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
* Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).
* Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2
* Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)

Exclusion Criteria:

* Subjects having severe glenohumeral arthritis
* History of prior tendon transfer
* Axillary nerve injury
* Deltoid deficiency
* Subjects with pseudo paralysis
* History of post-operative deep shoulder infection
* Non-English-speaking subjects.
* Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study
* Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)

Primary outcomes:
measure: 12-point difference in American Shoulder and Elbow Surgeon (ASES) scores
timeFrame: At one year post-operative follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: U of Maryland Baltimore
state: Maryland
Study officials:
affiliation: U of Maryland Baltimore
name: Ashfaq S Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References: