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NCT00757289 Clinical Trial

Platelet-rich-plasma Treating Tennis Elbow

Pain Clinical Trial

Official title:
Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00757289
Other study ID # BMET NL 03
Secondary ID
Status Completed
Phase N/A
First received September 22, 2008
Last updated May 17, 2017
Start date August 2007
Est. completion date January 2009

Study information
Verified date May 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is to compare the efficacy of autologous platelet concentrate injections to corticosteroid injection in patients suffering from tennis elbow with respect to pain and function.

Description:

Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. Data will be collected before the procedure, 4, 8, 12, 26 weeks and 1 year after the procedure. The main outcome measures of this study are pain and function measured with questionnaires.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date January 2009
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• PRP Injection
PRP Injection
• Corticosteroid Injection
Corticosteroid Injection

Locations
Country Name City State
Netherlands Elisabeth ziekenhuis Tilburg

Sponsors (1)
Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analog Score - Pain 4months,12 months,24months & 52 months
Secondary DASH 4months,12months,24months & 52 months
Secondary Complications Anytime
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