Back to resultsEffect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
Primary Purpose
Rotator Cuff Tear
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Postoperative early passive motion
Sling
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear
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
Sites / Locations
- Hospital Italiano de Buenos AiresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Early passive motion
Immobilization
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
MRI
Secondary Outcome Measures
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.
Range of Motion
VAS of pain
visual analogue scale of pain
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.
Full Information
NCT ID
NCT01502098
First Posted
December 24, 2011
Last Updated
January 9, 2012
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT01502098
Brief Title
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early passive motion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Immobilization
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Postoperative early passive motion
Intervention Description
Shoulder exercises starting on the first postoperative day
Intervention Type
Other
Intervention Name(s)
Sling
Intervention Description
Sling for 4 weeks
Primary Outcome Measure Information:
Title
MRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)
Description
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.
Time Frame
1, 3, 6 months
Title
Range of Motion
Time Frame
1, 3, 6 months
Title
VAS of pain
Description
visual analogue scale of pain
Time Frame
1, 3, 6 months
Title
WORC
Description
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.
Time Frame
1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan M. Lopez Ovenza, MD
Phone
15-5-9249686
Email
juanmanuel.lopez@hospitalitaliano.org.ar
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1118
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Manuel Lopez Ovenza, MD
Email
juanmanuel.lopez@hospitalitaliano.org.ar
12. IPD Sharing Statement
Learn more about this trial
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
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