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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01815177

Enrollment

Registered

2013-03-20

Start date

2013-03-31

Completion date

2015-05-31

Last updated

2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

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.

Interventions

DEVICEArthroscopic transosseous fixation

DEVICESuture anchors

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026