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Clinical Trials/NCT01815177
NCT01815177
Completed
Not Applicable

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

University of Milan1 site in 1 country75 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tears
Sponsor
University of Milan
Enrollment
75
Locations
1
Primary Endpoint
Pain
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pietro Randelli, MD

Assistant Professor

University of Milan

Eligibility Criteria

Inclusion Criteria

  • Age \> 18, \<65
  • Rotator cuff tears
  • Patients given written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Shoulder Stiffness(Postoperative passive range of motion is measured 2 months after surgery)

Study Sites (1)

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