Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

University of Milan

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Device: Arthroscopic transosseous fixation; Device: Suture anchors

Study type: Interventional

Funder types: Other

Identifiers

NCT01815177

Shoulder01

Details and patient eligibility

About

Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to arthroscopic suture anchor.

This novel technique that allows surgeons to perform a standardized arthroscopic transosseous (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the incidence of shoulder stiffness.

The aim of the this study is to compare clinical outcomes of two groups of patients: patients that received an arthroscopic transosseous fixation using the ArthroTunneler tunneling device (Tornier Inc, Edina, Minnesota) versus patients that received an arthroscopic rotator cuff repair using suture anchors.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18, <65
• Rotator cuff tears
• Patients given written informed consent
• BMI ≤ 33

Exclusion criteria

• Age > 65, < 18
• previous surgical intervention
• Informed consent not accepted
• Serious comorbidity
• Diabetes
• Metabolic Disorders
• Active infections
• Muscular Atrophy
• Biceps Tenodesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Arthroscopic transosseous fixation

Experimental group

Description:

Patients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair

Treatment:

Device: Arthroscopic transosseous fixation

Repair using suture anchors

Other group

Description:

Patients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors.

Treatment:

Device: Suture anchors