Platelet-rich-plasma Treating Tennis Elbow
May 17, 2017 updated by: Zimmer Biomet
Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tilburg, Netherlands
- Elisabeth Ziekenhuis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
PRP injection
|
PRP Injection
|
|
ACTIVE_COMPARATOR: 2
Corticosteroid Injection
|
Corticosteroid Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Analog Score - Pain
Time Frame: 4months,12 months,24months & 52 months
|
4months,12 months,24months & 52 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complications
Time Frame: Anytime
|
Anytime
|
|
DASH
Time Frame: 4months,12months,24months & 52 months
|
4months,12months,24months & 52 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Taco Gosens, MD, Elisabeth Ziekenhuis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (ACTUAL)
January 1, 2008
Study Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
September 22, 2008
First Submitted That Met QC Criteria
September 22, 2008
First Posted (ESTIMATE)
September 23, 2008
Study Record Updates
Last Update Posted (ACTUAL)
May 19, 2017
Last Update Submitted That Met QC Criteria
May 17, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMET NL 03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.