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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

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 - Platelet-rich plasma in calcific tendinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44579
Enrollment
80
Registered
2014-02-25
Start date
2014-08-12
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

calcifying tendinitis tendinosis calcarea

Interventions

Participants in the PRP-group will receive an intratendinous injection of PRP after the NACD procedure is completed. Participants in the control group will receive the usual care (intrabursal inject

Sponsors

Ziekenhuisgroep Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
A numeric rating scale (NRS) will be used to assess pain reduction. Primary endpoint is 6 months post barbotage.

Secondary

MeasureTime frame
Shoulder function and quality of life will be assessed by respectively the Constant-Murley shoulder score and the EQ-5D questionnaire. Ultrasound will be used to visualize tendon recovery, an AP shoulder x-ray will be used to score resorption of calcific deposits. Follow-up measurements will take place after 6 weeks and after 3, 6, 12 and 24 months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)