Platelet-Rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation - Full Text View

Sponsored by:	Meir Medical Center
Information provided by:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT00743873

Purpose

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.

Condition	Intervention	Phase
Patella-Dislocation	Biological: Plasma Rich in Growth Factors (PRGF) Drug: placebo	Phase II Phase III

MedlinePlus related topics: Dislocations

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PRP Treatment for Medial Retinaculum Tear - Randomized-Double-Blind-Placebo Control Trail

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator saline	Drug: placebo injection of 6 cc of saline into injured area
1: Experimental Plasma Rich in Growth Factors (PRGF)	Biological: Plasma Rich in Growth Factors (PRGF) US guided IM injection 3-6mg

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 18-40 years old
first time patella dislocation

Exclusion Criteria:

pregnancy
mental or physical disabilities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743873

Contacts

Contact: omer mei-dan, dr

+972 9 7472549

OMER.MEI-DAN@CLALIT.ORG.IL

Locations

Israel
Meir medical center	Recruiting
Kfar Saba, Israel
Contact: omer mei dan +972 9 7472549 OMER.MEI-DAN@CLALIT.ORG.IL
Principal Investigator: Gidon Man, dr
Sub-Investigator: Iftach Chetzroni, dr
Sub-Investigator: Gay Maoz, dr

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator:

Omer Mei Dan, Dr

Meir Medical Center

More Information

Responsible Party:	Meir Medical Center ( Omer Mei-Dan )
Study ID Numbers:	4000
Study First Received:	August 28, 2008
Last Updated:	September 7, 2008
ClinicalTrials.gov Identifier:	NCT00743873
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Meir Medical Center:

medial retinaculum tear s/p patella dislocation

Study placed in the following topic categories:

Lacerations
Patellar Dislocation
Dislocations
Wounds and Injuries

Knee Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on January 16, 2009