Skip to main content
OpenTrials
Completed

NCT Number: NCT01815177

Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico San Donato (istituto di ricovero e cura a carattere scientifico)

San Donato Milanese, Milano, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic transosseous fixation

Device

Other names: ArthroTunneler transosseous tunneling device (Tornier Inc)

Suture anchors

Device

Primary outcomes

  1. Pain

    Time frame: 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 outcomes

  1. Shoulder Stiffness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

Advantages of Arthroscopic Rotator Cuff Repair With Transosseous Suture Technique. A Prospective Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 20, 2013
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.