Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation
NCT ID: NCT01815177
Last Updated: 2016-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
75 participants
INTERVENTIONAL
2013-03-31
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
NCT03797287
Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled
NCT01877772
Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture
NCT06431191
Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears
NCT01039571
Rotator Cuff Repair With Arthroscopic Acromioplasty (Shaving the Acromion Bone) Versus Repair Without Acromioplasty
NCT00664794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arthroscopic transosseous fixation
Patients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair
Arthroscopic transosseous fixation
Repair using suture anchors
Patients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors.
Suture anchors
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arthroscopic transosseous fixation
Suture anchors
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Rotator cuff tears
* Patients given written informed consent
* BMI ≤ 33
Exclusion Criteria
* previous surgical intervention
* Informed consent not accepted
* Serious comorbidity
* Diabetes
* Metabolic Disorders
* Active infections
* Muscular Atrophy
* Biceps Tenodesis
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Milan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pietro Randelli, MD
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pietro Randelli, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Policlinico S. Donato
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Policlinico San Donato (istituto di ricovero e cura a carattere scientifico)
San Donato Milanese, Milano, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Shoulder01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.