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Operative Versus Non-operative Management of Rotator Cuff Tear

NCT00695981 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-22

No results posted yet for this study

Summary

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. The investigators 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.

The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Rotator cuff repair

Rotator cuff repair + physical therapy according to a standardized protocol

PROCEDURE

Conservative treatment

Physiotherapy according to a standardized protocol

Sponsors & Collaborators

  • Academy of Finland

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Central Finland Hospital District

    lead OTHER

Principal Investigators

  • Juha Paloneva, MD, PhD · Central Finland Health Care District, University of Eastern Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2017-01-31
Completion
2028-06-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00695981 on ClinicalTrials.gov