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Sponsored by: |
Meir Medical Center |
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Information provided by: | Meir Medical Center |
ClinicalTrials.gov Identifier: | NCT00743873 |
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 |
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 |
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
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Drug: placebo
injection of 6 cc of saline into injured area
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1: Experimental
Plasma Rich in Growth Factors (PRGF)
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Biological: Plasma Rich in Growth Factors (PRGF)
US guided IM injection 3-6mg
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: omer mei-dan, dr | +972 9 7472549 | OMER.MEI-DAN@CLALIT.ORG.IL |
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 |
Principal Investigator: | Omer Mei Dan, Dr | Meir Medical Center |
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 |
medial retinaculum tear s/p patella dislocation |
Lacerations Patellar Dislocation Dislocations Wounds and Injuries |
Knee Injuries Disorders of Environmental Origin Leg Injuries |