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Platelet-rich-plasma Treating Tennis Elbow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00757289
First received: September 22, 2008
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  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:

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 June 18, 2013