Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation

This study has been completed.

Sponsor:

Information provided by:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT00743873

First received: August 28, 2008

Last updated: July 10, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 28, 2008

Last Updated Date

July 10, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

redaction in healing time and recurrence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00743873 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation

Official Title ^ICMJE

PRP Treatment for Medial Retinaculum Tear - Randomized-Double-Blind-Placebo Control Trail

Brief Summary

To check the influence of injected platelet-rich plasma (PRP) on the healing of medial retinaculum and the redaction in recurrent dislocation of the patella.

Detailed Description

Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Patella-Dislocation

Intervention ^ICMJE

Biological: Plasma Rich in Growth Factors (PRGF)
US guided IM injection 3-6mg

Other Name: platelet-derived preparation rich in growth factors
Drug: placebo
injection of 6 cc of saline into injured area

Other Name: saline 0.9% NaCl

Study Arm (s)

Placebo Comparator: 2
saline

Intervention: Drug: placebo
Experimental: 1
Plasma Rich in Growth Factors (PRGF)

Intervention: Biological: Plasma Rich in Growth Factors (PRGF)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age 18-40 years old
first time patella dislocation

Exclusion Criteria:

pregnancy
mental or physical disabilities

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00743873

Other Study ID Numbers ^ICMJE

4000

Has Data Monitoring Committee

Yes

Responsible Party

Omer Mei-Dan, Meir Medical Center

Study Sponsor ^ICMJE

Meir Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Omer Mei Dan, Dr

Meir Medical Center

Information Provided By

Meir Medical Center

Verification Date

July 2011

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

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