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Calcific tendinitis of the rotator cuff: a randomized controlled trial to the effects of the adjuvant application of platelet-rich plasma after needle aspiration of calcific deposits

Completed
Conditions
calcifying tendinitis
tendinosis calcarea
10043237
Registration Number
NL-OMON44579
Lead Sponsor
Ziekenhuisgroep Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

18 years of age and older
Symptoms for over 6 months
Clinical and radiographic signs of calcific tendinitis
Not responding well to at least 2 types conservative treatment.
Indication needle aspiration of calcific deposits by orthopedic surgeon

Exclusion Criteria

55 years of age and older
An allergy for one of the products used during this study
Other conditions that may affect the recovery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>A numeric rating scale (NRS) will be used to assess pain reduction. Primary<br /><br>endpoint is 6 months post barbotage.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Shoulder function and quality of life will be assessed by respectively the<br /><br>Constant-Murley shoulder score and the EQ-5D questionnaire. Ultrasound will be<br /><br>used to visualize tendon recovery, an AP shoulder x-ray will be used to score<br /><br>resorption of calcific deposits. Follow-up measurements will take place after 6<br /><br>weeks and after 3, 6, 12 and 24 months. </p><br>
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