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Clinical Trials/NCT01502098
NCT01502098UnknownNot Applicable

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

Hospital Italiano de Buenos Aires1 site in 1 country114 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
114
Locations
1
Primary Endpoint
MRI

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Postoperative complication (severe pain, thrombosis, infection)
  • •Psychiatric disorder

Arms & Interventions

Early passive motion

Active Comparator

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.

Intervention: Postoperative early passive motion (Procedure)

Immobilization

No Intervention

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: Sling (Other)

Outcomes

Primary Outcomes

MRI

Time Frame: 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lopez Ovenza Juan Manuel

Principal Investigator

Hospital Italiano de Buenos Aires

Study Sites (1)

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