Operative Versus Non-Operative Management of Rotator Cuff Tear - Full Text View

Sponsors and Collaborators:	Central Finland Hospital District Academy of Finland National Research and Development Centre for Welfare and Health
Information provided by:	Central Finland Hospital District
ClinicalTrials.gov Identifier:	NCT00695981

Purpose

This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled.

The aim of the study is to search out evidence based data of indications for rotator cuff repair. We also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected.

We hypothesise that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

Condition	Intervention
Rotator Cuff Tear	Procedure: Rotator cuff repair surgery Procedure: Non-operative treatment

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effectiveness and Cost-Effectiveness of Operative and Non-Operative Management of Rotator Cuff Tear

Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:

Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3, 6, 12, 24 months and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Surgery	Procedure: Rotator cuff repair surgery Rotator cuff repair
2: Active Comparator Conservative treatment	Procedure: Non-operative treatment Physiotherapy according to a standardized protocol

Detailed Description:

Subgroup analyses:

age
sex
duration of symptoms
presence of trauma before symptoms
size of tear
degenerative findings
other findings in MRI or arthroscopy
type of operation
co-morbidities
occupation
pain (VAS)
objective shoulder function
activities of daily living

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age over 35 years
duration of symptoms at least three months despite of non-operative treatment
the patient accepts both treatment options (operative and conservative)
a full-thickness rotator cuff tear in MRI arthrography

Exclusion Criteria:

previous shoulder operations
too high risk for operation
any disease or social problem reducing the ability to co-operate
rheumatoid arthritis
severe arthrosis of the glenohumeral or acromioclavicular joint
irreparable rotator cuff tear (including rotator cuff tear arthropathy)
progressive malign disease
adhesive capsulitis
high-energy trauma before symptoms
cervical syndrome
shoulder instability

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695981

Contacts

Contact: Juha Paloneva, MD, PhD	358-14-269-1811	juha.paloneva@ksshp.fi
Contact: Ilkka Kiviranta, MD, PhD	358-50-427-1807	ilkka.kiviranta@helsinki.fi

Locations

Finland
Central Finland Central Hospital	Recruiting
Jyväskylä, Finland, FIN-40620
Contact: Juha Paloneva, MD, PhD +358 14 2691811 juha.paloneva@ksshp.fi
Principal Investigator: Juha Paloneva, MD, PhD
Sub-Investigator: Sanna Koskela, MD
Sub-Investigator: Hannu Kautiainen
Sub-Investigator: Timo Järvelä, MD, PhD
Sub-Investigator: Ylinen Jari, MD, PhD

Sponsors and Collaborators

Central Finland Hospital District

Academy of Finland

National Research and Development Centre for Welfare and Health

Investigators

Principal Investigator:

Ilkka Kiviranta, MD, PhD

Central Finland Health Care District

More Information

Publications:

Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63. Review.

Responsible Party:	University of Helsinki ( Ilkka Kiviranta, MD, PhD, Professor )
Study ID Numbers:	B07103-2
Study First Received:	March 17, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00695981
Health Authority:	Finland: Ethics Committee

Keywords provided by Central Finland Hospital District:

Rotator cuff
Arthroscopic surgery
Open surgery
Physiotherapy

Physical therapy
Effectiveness
RCT
cost-effectiveness

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on January 16, 2009