Platelet-Rich-Plasma Treating Tennis Elbow - Full Text View

Sponsored by:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00757289

Purpose

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	Intervention
Pain	Biological: PRP Injection Biological: Corticosteroid Injection

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Platelet-Rich-Plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2016
Estimated Primary Completion Date:	August 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PRP injection	Biological: PRP Injection PRP Injection
2: Active Comparator Corticosteroid Injection	Biological: Corticosteroid Injection Corticosteroid Injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757289

Contacts

Contact: Taco Gosens, MD

013-5391313

Locations

Netherlands
Elisabeth ziekenhuis	Recruiting
Tilburg, Netherlands
Contact: Taco Gosens, MD 013-5391313

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Taco Gosens, MD

Elisabeth ziekenhuis

More Information

No publications provided

Responsible Party:	Biomet Netherlands ( Joanne Bloemsaat, Clinical Manager )
Study ID Numbers:	BMET NL 03
Study First Received:	September 22, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00757289 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Biomet, Inc.:

Tennis Elbow

Study placed in the following topic categories:

Musculoskeletal Diseases
Tennis Elbow
Wounds and Injuries

Disorders of Environmental Origin
Pain
Arm Injuries

Additional relevant MeSH terms:

Musculoskeletal Diseases
Tennis Elbow
Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

ClinicalTrials.gov processed this record on May 07, 2009