Platelet-rich-plasma Treating Tennis Elbow - Tabular View

Tracking Information

First Received Date ^ICMJE

September 22, 2008

Last Updated Date

December 3, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Analog Score - Pain [ Time Frame: 4months,12 months,24months & 52 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00757289 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

DASH [ Time Frame: 4months,12months,24months & 52 months ] [ Designated as safety issue: No ]
Complications [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Platelet-rich-plasma Treating Tennis Elbow

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

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

Study Arms / Comparison Groups

1: Experimental
PRP injection

Intervention: Biological: PRP Injection
2: Active Comparator
Corticosteroid Injection

Intervention: Biological: Corticosteroid Injection

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

January 2009

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00757289

Responsible Party

Joanne Bloemsaat, Clinical Manager, Biomet Netherlands

Study ID Numbers ^ICMJE

BMET NL 03

Study Sponsor ^ICMJE

Biomet, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Taco Gosens, MD

Elisabeth ziekenhuis

Information Provided By

Biomet, Inc.

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP