Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

Study Overview
=================
Brief Summary
-----------------
The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.

Official Title
-----------------
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Procedure: Postoperative early passive motion
* Other: Sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients skeletally mature (older 18 years old) Small or medium rupture of rotator cuff Repaired with arthroscopic double row technique Exclusion Criteria: Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants) AC arthritis with mumford procedure Smokers Diabetes Postoperative complication (severe pain, thrombosis, infection) Psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early passive motion<br>Pendulum exercises starting on the first postoperative day. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises were not permitted until four weeks after surgery. | Procedure: Postoperative early passive motion<br>* Shoulder exercises starting on the first postoperative day<br>|
| No Intervention: Immobilization<br>Immobilization with sling during a month. Pendulum exercises starting on the fourth postoperative week. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises. | Other: Sling<br>* Sling for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale) | The ASES is 100-point standardized shoulder-assessment self-report form, 50 points of which are derived from patient self-report of pain on a visual analog scale and 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living derived using a four-point ordinal scale. | 1, 3, 6 months | 
| Range of Motion |  | 1, 3, 6 months | 
| VAS of pain | visual analogue scale of pain | 1, 3, 6 months | 
| WORC | The Western Ontario Rotator Cuff Index (WORC) is a self-report questionnaire developed specifically to evaluate disability in persons with pathology of the rotator cuff of the shoulder. | 1, 3, 6 months |