Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Device: Arthroscopic transosseous fixation
* Device: Suture anchors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroscopic transosseous fixation<br>Patients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair | Device: Arthroscopic transosseous fixation<br> <br> * Other names: ArthroTunneler transosseous tunneling device (Tornier Inc);|
| Other: Repair using suture anchors<br>Patients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors. | Device: Suture anchors<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |