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Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

Sponsor
University of Milan (Other)
Overall Status
Completed
CT.gov ID
NCT01815177
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
26
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Arthroscopic transosseous fixation
  • Device: Suture anchors
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Advantages of Arthroscopic Rotator Cuff Repair With Transosseous Suture Technique. A Prospective Randomized Controlled Trial
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arthroscopic transosseous fixation

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

Device: Arthroscopic transosseous fixation
Other Names:
  • ArthroTunneler transosseous tunneling device (Tornier Inc)

    		•
    Other: Repair using suture anchors

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

    Device: Suture anchors

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Policlinico San Donato (istituto di ricovero e cura a carattere scientifico) San Donato Milanese Milano Italy 20097

    Sponsors and Collaborators

    • University of Milan

    Investigators

    • Principal Investigator: Pietro Randelli, MD, IRCCS Policlinico San Donato

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pietro Randelli, MD, Assistant Professor, University of Milan
    ClinicalTrials.gov Identifier:
    NCT01815177
    Other Study ID Numbers:
    • Shoulder01
    First Posted:
    Mar 20, 2013
    Last Update Posted:
    Feb 17, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Rotator Cuff Injuries

    Study Results

    No Results Posted as of Feb 17, 2016