Platelet-rich-plasma Treating Tennis Elbow
Sponsor
Zimmer Biomet (Industry)
Overall Status
Completed
CT.gov ID
NCT00757289
Collaborator
(none)
106
1
2
17.1
6.2
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Actual Enrollment
:
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study
Study Start Date
:
Aug 1, 2007
Actual Primary Completion Date
:
Jan 1, 2008
Actual Study Completion Date
:
Jan 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 PRP injection |
Biological: PRP Injection
PRP Injection
|
| Active Comparator: 2 Corticosteroid Injection |
Biological: Corticosteroid Injection
Corticosteroid Injection
|
Outcome Measures
Primary Outcome Measures
- Visual Analog Score - Pain [4months,12 months,24months & 52 months]
Secondary Outcome Measures
- DASH [4months,12months,24months & 52 months]
- Complications [Anytime]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Elisabeth ziekenhuis | Tilburg | Netherlands |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Principal Investigator: Taco Gosens, MD, Elisabeth ziekenhuis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00757289
Other Study ID Numbers:
- BMET NL 03
First Posted:
Sep 23, 2008
Last Update Posted:
May 19, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Zimmer Biomet
Additional relevant MeSH terms: