Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

Not Applicable

Completed

• Conditions: Rotator Cuff Tears
• Interventions: Device: Arthroscopic transosseous fixation; Device: Suture anchors

• Registration Number: NCT01815177
• Lead Sponsor: University of Milan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic transosseous fixation	Arthroscopic transosseous fixation	Patients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair
Repair using suture anchors	Suture anchors	Patients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors.

Primary Outcome Measures

Name	Time	Method
Pain	first 28 days after surgery	Paracetamol/Codeine 500/30 is given to every patient at 08.00 and 20.00 for the first 5 days. The patient is highly recommended to indicate his pain at 19.30 and to write if there is any modification in the assumption of pain killers.

Secondary Outcome Measures

Name	Time	Method
Shoulder Stiffness	Postoperative passive range of motion is measured 2 months after surgery	For evaluation of shoulder stiffness, passive range of motion is measured with a goniometer by a single examiner in 3 directions: forward elevation, external rotation at the side and internal rotation at the back

Trial Locations

Locations (1)

Policlinico San Donato (istituto di ricovero e cura a carattere scientifico); 🇮🇹 San Donato Milanese, Milano, Italy