Platelet-rich-plasma Treating Tennis Elbow - Full Text View

Sponsor:	Biomet, Inc.
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study

Resource links provided by NLM:

MedlinePlus related topics: Elbow Injuries and Disorders

Drug Information available for: Corticosteroids

U.S. FDA Resources

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 ]

Enrollment:	106
Study Start Date:	August 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

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.

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

Locations

Netherlands
Elisabeth ziekenhuis
Tilburg, Netherlands

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Taco Gosens, MD

Elisabeth ziekenhuis

More Information

No publications provided

Responsible Party:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00757289 History of Changes
Other Study ID Numbers:	BMET NL 03
Study First Received:	September 22, 2008
Last Updated:	September 27, 2011
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Biomet, Inc.:

Tennis Elbow

Additional relevant MeSH terms:

Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012