Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 10, 2012
January 1, 2012
1.4 years
December 24, 2011
January 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
MRI
6 months
Secondary Outcomes (4)
ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)
1, 3, 6 months
Range of Motion
1, 3, 6 months
VAS of pain
1, 3, 6 months
WORC
1, 3, 6 months
Study Arms (2)
Early passive motion
ACTIVE COMPARATORPendulum 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
NO INTERVENTIONImmobilization 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.
Interventions
Shoulder exercises starting on the first postoperative day
Eligibility Criteria
You may qualify if:
- Patients skeletally mature (older 18 years old)
- Small or medium rupture of rotator cuff
- Repaired with arthroscopic double row technique
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Italiano de Buenos Aires
Buenos Aires, 1118, Argentina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 24, 2011
First Posted
December 30, 2011
Study Start
January 1, 2012
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
January 10, 2012
Record last verified: 2012-01