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Sponsors and Collaborators: |
Central Finland Hospital District Academy of Finland National Research and Development Centre for Welfare and Health |
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Information provided by: | Central Finland Hospital District |
ClinicalTrials.gov Identifier: | NCT00695981 |
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 |
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Rotator Cuff Tear |
Procedure: Rotator cuff repair surgery Procedure: Non-operative treatment |
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 |
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 |
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1: Active Comparator
Surgery
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Procedure: Rotator cuff repair surgery
Rotator cuff repair
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2: Active Comparator
Conservative treatment
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Procedure: Non-operative treatment
Physiotherapy according to a standardized protocol
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Subgroup analyses:
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Ilkka Kiviranta, MD, PhD | Central Finland Health Care District |
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 |
Rotator cuff Arthroscopic surgery Open surgery Physiotherapy |
Physical therapy Effectiveness RCT cost-effectiveness |
Lacerations |