Arthroscopic Rotator Cuff Tear Repair: Single Versus Double Layer Fixation

Austrian Research Group for Regenerative and Orthopedic Medicine

Status: Unknown

Conditions: Rotator Cuff Tear

Treatments: Procedure: double layer fixation; Procedure: single layer fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03362320

SLvsDL

Details and patient eligibility

About

Retear rates after arthroscopic rotator cuff repairs remain unsatisfactorily high. Recently, attention has been paid to restore the rotator cuff's native anatomy by reconstructing the superior joint capsule. However, the debate whether to reconstruct only the superficial tendinous part or also the deeper capsulo-ligamentous part of the rotator cuff is ongoing. Thus, the intention of the present study is to compare double-layer versus single-layer arthroscopic rotator cuff repair regarding retear rate and clinical outcome.

Enrollment: 70 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with repairable supra- and infraspinatus tears scheduled for arthroscopic rotator cuff fixation
• tear size of at least 2.5 cm and up to 4.0 cm
• signed informed consent

Exclusion criteria

• axillary nerve palsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

double layer fixation

Experimental group

Description:

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with double layer fixation

Treatment:

Procedure: double layer fixation

single layer fixation

Experimental group

Description:

Patients with torn infraspinatus and supraspinatus tendon undergoing arthroscopy rotator cuff repair with single layer fixation

Treatment:

Procedure: single layer fixation