Back to resultsPlatelet-rich-plasma Treating Tennis Elbow
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PRP Injection
Corticosteroid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Tennis Elbow
Eligibility Criteria
Inclusion Criteria:
- Patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon
Exclusion Criteria:
Sites / Locations
- Elisabeth ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
PRP injection
Corticosteroid Injection
Outcomes
Primary Outcome Measures
Visual Analog Score - Pain
Secondary Outcome Measures
DASH
Complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00757289
Brief Title
Platelet-rich-plasma Treating Tennis Elbow
Official Title
Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Tennis Elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PRP injection
Arm Title
2
Arm Type
Active Comparator
Arm Description
Corticosteroid Injection
Intervention Type
Biological
Intervention Name(s)
PRP Injection
Intervention Description
PRP Injection
Intervention Type
Biological
Intervention Name(s)
Corticosteroid Injection
Intervention Description
Corticosteroid Injection
Primary Outcome Measure Information:
Title
Visual Analog Score - Pain
Time Frame
4months,12 months,24months & 52 months
Secondary Outcome Measure Information:
Title
DASH
Time Frame
4months,12months,24months & 52 months
Title
Complications
Time Frame
Anytime
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taco Gosens, MD
Organizational Affiliation
Elisabeth ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elisabeth ziekenhuis
City
Tilburg
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet-rich-plasma Treating Tennis Elbow
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