Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815177
• Other study ID #: Shoulder01
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: February 16, 2016
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tears

Intervention

Device:
• Arthroscopic transosseous fixation

• Suture anchors

Locations

Country	Name	City	State
Italy	Policlinico San Donato (istituto di ricovero e cura a carattere scientifico)	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View Citation

Longo UG, Franceschi F, Berton A, Maffulli N, Denaro V. Arthroscopic transosseous rotator cuff repair. Med Sport Sci. 2012;57:142-52. doi: 10.1159/000328900. Epub 2011 Oct 4. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first 28 days after surgery	No
Secondary	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	Postoperative passive range of motion is measured 2 months after surgery	No