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

NCT ID: NCT00743873

Last Updated: 2011-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Patella-Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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2

saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

injection of 6 cc of saline into injured area

1

Plasma Rich in Growth Factors (PRGF)

Group Type EXPERIMENTAL

Plasma Rich in Growth Factors (PRGF)

Intervention Type BIOLOGICAL

US guided IM injection 3-6mg

Interventions

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Plasma Rich in Growth Factors (PRGF)

US guided IM injection 3-6mg

Intervention Type BIOLOGICAL

placebo

injection of 6 cc of saline into injured area

Intervention Type DRUG

Other Intervention Names

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platelet-derived preparation rich in growth factors saline 0.9% NaCl

Eligibility Criteria

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Inclusion Criteria

* age 18-40 years old
* first time patella dislocation

Exclusion Criteria

* pregnancy
* mental or physical disabilities
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Meir Medical Center

Principal Investigators

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Omer Mei Dan, Dr

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir medical center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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4000

Identifier Type: -

Identifier Source: org_study_id

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