Platelet-rich Plasma in Calcific Tendinitis | NCT02173743

Studies
Platelet-rich Plasma in Calcific Tendinitis

NCT02173743

Sponsor

Orthopedisch Centrum Oost Nederland

Status

Completed

Last Update Posted

Apr 22, 2026Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Calcific Tendinitis

Interventions

PRP
Control

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ABR 47402	Other Identifier	Medical Ethical Committee Twente

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014Actual

Primary Completion Date

May 13, 2019Actual

Completion Date

May 13, 2019Actual

First Submitted Date

Jun 19, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific tendinitis which does not respond to conservative treatment. NACD is effective in approximately 70% of the patients.When NACD is not effective, surgery is often the only treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and the doctors treating those patients will benefit from a more effective minimal invasive treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering its positive effect on tissue repair, be a possible solution here.Previous research investigating the effects of PRP on other tendinopathies did, however, show controversial results. The aim of this double-blind randomized controlled trial is to investigate the effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder function, tendon recovery,resorption of calcific deposits, the percentage of patients with persistent complaints and quality of life.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP group	Experimental	PRP during barbotage	Other: PRP
Control group	Other	Regular barbotage	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP	Other	platelet enriched autologous blood plasma	PRP group
Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numeric Rating Scale (NRS) pain	Score to assess the amount of pain	6 months post barbotage

Secondary Outcomes

Measure	Description	Time Frame
Constant-Murley Score (CMS)	To assess shoulder function	6 weeks, 3 - 6- 12- 25 months post barbatoge
Quality of Life (EQ-5D)	score to assess the quality of life

Other Outcomes

Measure	Description	Time Frame
Tendon recovery	to visualize tendon recovery by ultrasound	6 weeks, 3-6-12-24 months post barbotage
calcifications	size of calcifications (X-ray)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 yrs
clinical manifestions of tendinitis calcarea (pain, stifness, lock sensations, muscle atrophy)
persistent pain sympoms >6 months
standardized AP x-ray shows calcific deposit of > 5mm & morphologic Type I & II deposits (classification of Gärtner en Simons)
ineffective intervention > 2 types of conservative treatment (among which are non-steroidal anti-inflammatory drugs, physiotherapy, local anesthesia injection and/or corticosteroids, extracorporele shock wave therapy)
indication and referral for barbotage by orthopeadic surgeon

Exclusion Criteria:

age > 55 years
morphological type III deposits according to classification of Gärtner and Simons) (as indicated by standardized x-ray AP)
bigliani type III acromion, and acromial spur of acromioclavicular osteovyt
previous (ineffective) barbotage
the existence of other shoulder related injuries next to calcific tendinitis (full-thickness rupture of the rotator cuff, adhesive capsulitis (frozen shoulder), arthrosis of the glenohumeral- or acromioclavicalar joint
shoulder joint instability
shoulder injury due to trauma or previous shoulder surgeries
other types of disorders that could negatively influence the outcomes (rheumatic arthritis. cervical spine disorders, neurological upper extremity disorders, diabetes mellitus, infections, blood disorders, malignity, pregnancy)
known allergic responses to one of the medications applied in the current study (lidocaine, bupivacaine, kenacort)
usage of anti-coagulants other than ascal of plavix

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Edwin Ooms, PhD	OCON	Study Director
Rianne Huis in 't Veld, PhD	OCON	Study Director
Bart Oudelaar, MSc	OCON	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedisch Centrum Oost Nederland/ZGT		Hengelo	Overijssel	7550 AM	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33566629	Derived	Oudelaar BW, Huis In 't Veld R, Ooms EM, Schepers-Bok R, Nelissen RGHH, Vochteloo AJH. Efficacy of Adjuvant Application of Platelet-Rich Plasma After Needle Aspiration of Calcific Deposits for the Treatment of Rotator Cuff Calcific Tendinitis: A Double-Blinded, Randomized Controlled Trial With 2-Year Follow-up. Am J Sports Med. 2021 Mar;49(4):873-882. doi: 10.1177/0363546520987579. Epub 2021 Feb 10.