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Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

H

Hospital Italiano de Buenos Aires

Status

Unknown

Conditions

Rotator Cuff Tear

Treatments

Procedure: Postoperative early passive motion
Other: Sling

Study type

Interventional

Funder types

Other

Identifiers

NCT01502098
CEPI:1780

Details and patient eligibility

About

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.

Enrollment

114 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

114 participants in 2 patient groups

Early passive motion
Active Comparator group
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.
Treatment:
Procedure: Postoperative early passive motion
Immobilization
No Intervention group
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.
Treatment:
Other: Sling

Trial contacts and locations

1

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Central trial contact

Juan M. Lopez Ovenza, MD

Data sourced from clinicaltrials.gov

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