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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743873
First Posted: August 29, 2008
Last Update Posted: July 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Meir Medical Center
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP Treatment for Medial Retinaculum Tear - Randomized-Double-Blind-Placebo Control Trail

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • redaction in healing time and recurrence [ Time Frame: 1 year ]

Estimated Enrollment: 50
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
saline
Drug: placebo
injection of 6 cc of saline into injured area
Other Name: saline 0.9% NaCl
Experimental: 1
Plasma Rich in Growth Factors (PRGF)
Biological: Plasma Rich in Growth Factors (PRGF)
US guided IM injection 3-6mg
Other Name: platelet-derived preparation rich in growth factors

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00743873


Locations
Israel
Meir medical center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Omer Mei Dan, Dr Meir Medical Center
  More Information

Responsible Party: Omer Mei-Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00743873     History of Changes
Other Study ID Numbers: 4000
First Submitted: August 28, 2008
First Posted: August 29, 2008
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Meir Medical Center:
medial retinaculum tear s/p patella dislocation

Additional relevant MeSH terms:
Joint Dislocations
Patellar Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action