The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing

Study Overview
=================
Brief Summary
-----------------
Patients with complaints of shoulder pain or limitation of motion and had rotator cuff rupture diagnosed with magnetic resonance imaging will be analyzed and the patients with surgical indication will be included in a randomized fashion. One group of patient will undergo standard arthroscopic rotator cuff repair, while the other group will have microfracture procedure in addition to the standard arthroscopic repair. Before the operation, functional and clinical conditions will be recorded with Constant and American Shoulder and Elbow Surgeons Shoulder Score (ASES) universal shoulder scoring systems and Visual Analogue Scale(VAS) pain scale. The blood supply and healing of the tendon in the repair area will be compared by the doppler ultrasound (superb microvascular imaging) at the 2nd, 4th, 8th and 12th week after the operation. Post-operative clinical, functional status and pain levels will be evaluated with Constant, ASES and VAS pain scales at 24th week.

Official Title
-----------------
Early-term Effects of Microfracture on Tendon Vascularity and Healing in Arthroscopic Treatment of Chronic Rotator Cuff Tears: A Prospective Randomized Trial

Conditions
-----------------
Rotator Cuff Tears, Micro Fracture

Intervention / Treatment
-----------------
* Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair
* Procedure: Standard Arthroscopic Rotator Cuff Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: degenerative rotator cuff tears Exclusion Criteria: traumatic rotator cuff tears rheumatoid diseases previous surgery of rotator cuff tendon glenohumeral arthritis acromioclavicular arthritis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Arthroscopic Rotator Cuff Repair<br> | Procedure: Standard Arthroscopic Rotator Cuff Repair<br>* Standard Arthroscopic Rotator Cuff Repair<br>|
| Experimental: Microfracture and Arthroscopic Rotator Cuff Repair<br> | Procedure: Microfracture + Standard Arthroscopic Rotator Cuff Repair<br>* drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing early change of tendon and footprint area vascularity | we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity | 4th week | 
| assessing early change of tendon and footprint area vascularity | we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity | 8th week | 
| assessing early change of tendon and footprint area vascularity | we will evaluate it by superb microvascular imaging via ultrasound, this ultrasound software give us quantitative value of vascularity | 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome | This entity will be asses by functional scoring systems.These are American Shoulder and Elbow Surgeons Shoulder Score (ASES) and Constant Shoulder Score. The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. Constant Score was designed to assess the functional state of a normal, a diseased, or a treated shoulder.The Constant score contains both physician-completed and patient-reported portions. The four domains include pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability). | 24th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superb microvascular imaging, Rotator Cuff Tears, Micro Fracture