search
Back to results

Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Arthroscopic transosseous fixation
Suture anchors
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arthroscopic transosseous fixation

Repair using suture anchors

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain
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

Shoulder Stiffness
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

Full Information

First Posted
March 18, 2013
Last Updated
February 16, 2016
Sponsor
University of Milan
search

1. Study Identification

Unique Protocol Identification Number
NCT01815177
Brief Title
Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation
Official Title
Advantages of Arthroscopic Rotator Cuff Repair With Transosseous Suture Technique. A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic transosseous fixation
Arm Type
Experimental
Arm Description
Patients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair
Arm Title
Repair using suture anchors
Arm Type
Other
Arm Description
Patients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors.
Intervention Type
Device
Intervention Name(s)
Arthroscopic transosseous fixation
Other Intervention Name(s)
ArthroTunneler transosseous tunneling device (Tornier Inc)
Intervention Type
Device
Intervention Name(s)
Suture anchors
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
first 28 days after surgery
Secondary Outcome Measure Information:
Title
Shoulder Stiffness
Description
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
Time Frame
Postoperative passive range of motion is measured 2 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Randelli, MD
Organizational Affiliation
IRCCS Policlinico S. Donato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico San Donato (istituto di ricovero e cura a carattere scientifico)
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22011882
Citation
Garofalo R, Castagna A, Borroni M, Krishnan SG. Arthroscopic transosseous (anchorless) rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2012 Jun;20(6):1031-5. doi: 10.1007/s00167-011-1725-4. Epub 2011 Oct 20.
Results Reference
background
PubMed Identifier
23040550
Citation
Voos JE, Barnthouse CD, Scott AR. Arthroscopic rotator cuff repair: techniques in 2012. Clin Sports Med. 2012 Oct;31(4):633-44. doi: 10.1016/j.csm.2012.07.002.
Results Reference
background
PubMed Identifier
21986052
Citation
Longo UG, Franceschi F, Berton A, Maffulli N, Denaro V. Arthroscopic transosseous rotator cuff repair. Med Sport Sci. 2012;57:142-152. doi: 10.1159/000328900. Epub 2011 Oct 4.
Results Reference
background
PubMed Identifier
23239668
Citation
Salata MJ, Sherman SL, Lin EC, Sershon RA, Gupta A, Shewman E, Wang VM, Cole BJ, Romeo AA, Verma NN. Biomechanical evaluation of transosseous rotator cuff repair: do anchors really matter? Am J Sports Med. 2013 Feb;41(2):283-90. doi: 10.1177/0363546512469092. Epub 2012 Dec 13.
Results Reference
background
PubMed Identifier
22588393
Citation
Garrigues GE, Lazarus MD. Arthroscopic bone tunnel augmentation for rotator cuff repair. Orthopedics. 2012 May;35(5):392-7. doi: 10.3928/01477447-20120426-04.
Results Reference
background
PubMed Identifier
28339286
Citation
Randelli P, Stoppani CA, Zaolino C, Menon A, Randelli F, Cabitza P. Advantages of Arthroscopic Rotator Cuff Repair With a Transosseous Suture Technique: A Prospective Randomized Controlled Trial. Am J Sports Med. 2017 Jul;45(9):2000-2009. doi: 10.1177/0363546517695789. Epub 2017 Mar 24.
Results Reference
derived

Learn more about this trial

Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

We'll reach out to this number within 24 hrs