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Platelet-rich-plasma Treating Tennis Elbow

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ClinicalTrials.gov Identifier: NCT00757289
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Pain Biological: PRP Injection Biological: Corticosteroid Injection Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study
Study Start Date : August 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
PRP injection
Biological: PRP Injection
PRP Injection
Active Comparator: 2
Corticosteroid Injection
Biological: Corticosteroid Injection
Corticosteroid Injection



Primary Outcome Measures :
  1. Visual Analog Score - Pain [ Time Frame: 4months,12 months,24months & 52 months ]

Secondary Outcome Measures :
  1. DASH [ Time Frame: 4months,12months,24months & 52 months ]
  2. Complications [ Time Frame: Anytime ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757289


Locations
Netherlands
Elisabeth ziekenhuis
Tilburg, Netherlands
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Taco Gosens, MD Elisabeth ziekenhuis

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00757289     History of Changes
Other Study ID Numbers: BMET NL 03
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
Tennis Elbow

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries