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

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. Identifier: NCT00743873
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : July 12, 2011
Information provided by:
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Patella-Dislocation Biological: Plasma Rich in Growth Factors (PRGF) Drug: placebo Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : January 2008
Primary Completion Date : February 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations Tears
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 2
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

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • mental or physical disabilities

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 identifier (NCT number): NCT00743873

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

Responsible Party: Omer Mei-Dan, Meir Medical Center Identifier: NCT00743873     History of Changes
Other Study ID Numbers: 4000
First Posted: August 29, 2008    Key Record Dates
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
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action