Back to resultsPlatelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation
Primary Purpose
Patella-Dislocation
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Plasma Rich in Growth Factors (PRGF)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Patella-Dislocation focused on measuring medial retinaculum tear s/p patella dislocation
Eligibility Criteria
Inclusion Criteria:
- age 18-40 years old
- first time patella dislocation
Exclusion Criteria:
- pregnancy
- mental or physical disabilities
Sites / Locations
- Meir medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
2
1
Arm Description
saline
Plasma Rich in Growth Factors (PRGF)
Outcomes
Primary Outcome Measures
redaction in healing time and recurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00743873
Brief Title
Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation
Official Title
PRP Treatment for Medial Retinaculum Tear - Randomized-Double-Blind-Placebo Control Trail
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella-Dislocation
Keywords
medial retinaculum tear s/p patella dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
saline
Arm Title
1
Arm Type
Experimental
Arm Description
Plasma Rich in Growth Factors (PRGF)
Intervention Type
Biological
Intervention Name(s)
Plasma Rich in Growth Factors (PRGF)
Other Intervention Name(s)
platelet-derived preparation rich in growth factors
Intervention Description
US guided IM injection 3-6mg
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
saline 0.9% NaCl
Intervention Description
injection of 6 cc of saline into injured area
Primary Outcome Measure Information:
Title
redaction in healing time and recurrence
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-40 years old
first time patella dislocation
Exclusion Criteria:
pregnancy
mental or physical disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Mei Dan, Dr
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir medical center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Platelet-rich Plasma (PRP) Treatment for Medial Retinaculum Tear Post Medial Patellar Dislocation
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