Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

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

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Postoperative early passive motion; Other: Sling

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1118
    • Recruiting
    • Hospital Italiano de Buenos Aires
    • Contact: Juan Manuel Lopez Ovenza, MD; Email: juanmanuel.lopez@hospitalitaliano.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Early passive motion; 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; Shoulder exercises starting on the first postoperative day
NO_INTERVENTION: Immobilization; 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; Sling for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: December 24, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (ESTIMATE): December 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2012
• Last Update Submitted That Met QC Criteria: January 9, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: CEPI:1780