Platelet-rich Plasma in Calcific Tendinitis

Calcific Tendinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173743
• Other study ID #: NL47402.044.13
• Secondary ID: ABR 47402
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: May 13, 2019

Study information

• Verified date: May 2019
• Source: Orthopedisch Centrum Oost Nederland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 13, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcific Tendinitis
• Tendinopathy

Intervention

Other:
• PRP
platelet enriched autologous blood plasma
• Control
Regular barbotage/care as usual

Locations

Country	Name	City	State
Netherlands	Orthopedisch Centrum Oost Nederland/ZGT	Hengelo	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Orthopedisch Centrum Oost Nederland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tendon recovery	to visualize tendon recovery by ultrasound	6 weeks, 3-6-12-24 months post barbotage
Other	calcifications	size of calcifications (X-ray)	baseline, 3 + 12 months post barbotage
Other	plated plasma analysis	trombocytes analysis of PRP blood	baseline
Primary	Numeric Rating Scale (NRS) pain	Score to assess the amount of pain	6 months post barbotage
Secondary	Constant-Murley Score (CMS)	To assess shoulder function	6 weeks, 3 - 6- 12- 25 months post barbatoge
Secondary	Quality of Life (EQ-5D)	score to assess the quality of life	6 weeks, 3- 6- 12- 24 months post barbotage

External Links

•   hospital's url