Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
1 other identifier
interventional
240
1 country
3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedOctober 4, 2010
October 1, 2010
October 30, 2008
October 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
6 months
Secondary Outcomes (4)
Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)
6 months
Changes in Quality of life (SF-12 questionnaire).
6 months
Changes in Degree of joint mobility.(determined by goniometer).
6 months
Complications and/or adverse effects.
6 months
Study Arms (2)
1
EXPERIMENTALPRGF
2
ACTIVE COMPARATORHyaluronic Acid
Interventions
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
Eligibility Criteria
You may qualify if:
- Patients of both sexes and aged between 40 and 72 years.
- Diagnosed with osteoarthritis of the knee by radiological image.
- Pain in the joint equal to or greater than 2.5 points in EAV.
- Radiological severity:Value in the Ahlback score 3 or less.
- Body mass index between 20 and 30.
- Possibility for observation during follow-up period.
You may not qualify if:
- Bilateral Gonarthrosis requiring infiltration in both knees.
- Body mass index greater than 30.
- Diagnosed polyarticular disease.
- Severe mechanical deformation.
- Previous arthroscopy in the past year.
- Intraarticular infiltration of hyaluronic acid in the last 6 months.
- Rheumatic autoimmune systemic disease.
- Poorly controlled diabetes mellitus.
- Blood alterations.
- Immunosuppressive treatments and/or coumarinics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.
Vitoria-Gasteiz, Alava, Spain
Hospital Donostia.
Donostia / San Sebastian, Gipuzkoa, Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, Gipuzkoa, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikel Sanchez
UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.
- STUDY DIRECTOR
Jaime Usabiaga
Hospital Donostia
- STUDY DIRECTOR
Javier Albillos
Policlinica Gipuzkoa
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
January 1, 2008
Last Updated
October 4, 2010
Record last verified: 2010-10