Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hospital Italiano de Buenos Aires.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lopez Ovenza Juan Manuel, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01502098
First received: December 24, 2011
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Rotator Cuff Tear
Procedure: Postoperative early passive motion
Other: Sling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale) [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: No ]
  • VAS of pain [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: No ]
    visual analogue scale of pain

  • WORC [ Time Frame: 1, 3, 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 114
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502098

Contacts
Contact: Juan M. Lopez Ovenza, MD 15-5-9249686 juanmanuel.lopez@hospitalitaliano.org.ar

Locations
Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, 1118
Contact: Juan Manuel Lopez Ovenza, MD       juanmanuel.lopez@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
  More Information

No publications provided

Responsible Party: Lopez Ovenza Juan Manuel, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01502098     History of Changes
Other Study ID Numbers: CEPI:1780
Study First Received: December 24, 2011
Last Updated: January 9, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

ClinicalTrials.gov processed this record on September 14, 2014