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Platelet-rich Plasma in Calcific Tendinitis

Primary Purpose

Calcific Tendinitis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PRP
Control
Sponsored by
Orthopedisch Centrum Oost Nederland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcific Tendinitis focused on measuring plasma, calcific tendinitis, rotator cuff, PRP

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedisch Centrum Oost Nederland/ZGT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PRP group

Control group

Arm Description

PRP during barbotage

Regular barbotage

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS) pain
Score to assess the amount of pain

Secondary Outcome Measures

Constant-Murley Score (CMS)
To assess shoulder function
Quality of Life (EQ-5D)
score to assess the quality of life

Full Information

First Posted
June 19, 2014
Last Updated
May 14, 2019
Sponsor
Orthopedisch Centrum Oost Nederland
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1. Study Identification

Unique Protocol Identification Number
NCT02173743
Brief Title
Platelet-rich Plasma in Calcific Tendinitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 13, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopedisch Centrum Oost Nederland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis
Keywords
plasma, calcific tendinitis, rotator cuff, PRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
PRP during barbotage
Arm Title
Control group
Arm Type
Other
Arm Description
Regular barbotage
Intervention Type
Other
Intervention Name(s)
PRP
Intervention Description
platelet enriched autologous blood plasma
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Regular barbotage/care as usual
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) pain
Description
Score to assess the amount of pain
Time Frame
6 months post barbotage
Secondary Outcome Measure Information:
Title
Constant-Murley Score (CMS)
Description
To assess shoulder function
Time Frame
6 weeks, 3 - 6- 12- 25 months post barbatoge
Title
Quality of Life (EQ-5D)
Description
score to assess the quality of life
Time Frame
6 weeks, 3- 6- 12- 24 months post barbotage
Other Pre-specified Outcome Measures:
Title
Tendon recovery
Description
to visualize tendon recovery by ultrasound
Time Frame
6 weeks, 3-6-12-24 months post barbotage
Title
calcifications
Description
size of calcifications (X-ray)
Time Frame
baseline, 3 + 12 months post barbotage
Title
plated plasma analysis
Description
trombocytes analysis of PRP blood
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Ooms, PhD
Organizational Affiliation
OCON
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rianne Huis in 't Veld, PhD
Organizational Affiliation
OCON
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bart Oudelaar, MSc
Organizational Affiliation
OCON
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedisch Centrum Oost Nederland/ZGT
City
Hengelo
State/Province
Overijssel
ZIP/Postal Code
7550 AM
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33566629
Citation
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.
Results Reference
derived
Links:
URL
http://www.ocon.nl
Description
hospital's url

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Platelet-rich Plasma in Calcific Tendinitis

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