Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation
Advantages of Arthroscopic Rotator Cuff Repair With Transosseous Suture Technique. A Prospective Randomized Controlled Trial
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFebruary 17, 2016
February 1, 2016
1.2 years
March 18, 2013
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Shoulder Stiffness
Postoperative passive range of motion is measured 2 months after surgery
Study Arms (2)
Arthroscopic transosseous fixation
EXPERIMENTALPatients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair
Repair using suture anchors
OTHERPatients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors.
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18, \<65
- Rotator cuff tears
- Patients given written informed consent
- BMI ≤ 33
You may not qualify if:
- Age \> 65, \< 18
- previous surgical intervention
- Informed consent not accepted
- Serious comorbidity
- Diabetes
- Metabolic Disorders
- Active infections
- Muscular Atrophy
- Biceps Tenodesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico San Donato (istituto di ricovero e cura a carattere scientifico)
San Donato Milanese, Milano, 20097, Italy
Related Publications (6)
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.
PMID: 22011882BACKGROUNDVoos 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.
PMID: 23040550BACKGROUNDLongo 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.
PMID: 21986052BACKGROUNDSalata 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.
PMID: 23239668BACKGROUNDGarrigues GE, Lazarus MD. Arthroscopic bone tunnel augmentation for rotator cuff repair. Orthopedics. 2012 May;35(5):392-7. doi: 10.3928/01477447-20120426-04.
PMID: 22588393BACKGROUNDRandelli 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.
PMID: 28339286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pietro Randelli, MD
IRCCS Policlinico S. Donato
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 18, 2013
First Posted
March 20, 2013
Study Start
March 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2015
Last Updated
February 17, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share