Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
1 other identifier
interventional
56
1 country
1
Brief Summary
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2015
CompletedFirst Posted
Study publicly available on registry
February 25, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
February 19, 2018
CompletedFebruary 19, 2018
August 1, 2017
1.3 years
January 27, 2015
March 17, 2017
August 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It measures five items of pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68); thus, the total score range is 0-96. A higher value indicates a worst outcome. Only the final measures (at 24 weeks) are presented as part of the final analysis.
Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary Outcomes (2)
Change in the SF-12 Health Survey (Quality of Life)
Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
Change in the Visual Analog Scale (VAS) (Global Pain)
Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
Study Arms (2)
Unique application of PRP
EXPERIMENTALPatients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home
Triple application of PRP
ACTIVE COMPARATORPatients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home
Interventions
Autologous Platelet-Rich Plasma will be applied by a intra-articular injections
Patients would been shown rehabilitation exercises, to perform them at home
Eligibility Criteria
You may qualify if:
- Age between 18 and 90 years
- Patients with no previous treatment
- Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings)
You may not qualify if:
- Age \<18 and \> 90 years
- Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic findings)
- Patients with asociated Rheumatic syndromes
- Patients with anticoagulant therapy
- Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections
- Pregnant patients
- Patients with prosthetic or orthotic.
- Patients with hemoglobin values \< 11g/dl , platelets \< 150,000/μL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Facultad de Medicina UANL
Monterrey, Nuevo León, 66235, Mexico
Related Publications (6)
Martel-Pelletier J, Boileau C, Pelletier JP, Roughley PJ. Cartilage in normal and osteoarthritis conditions. Best Pract Res Clin Rheumatol. 2008 Apr;22(2):351-84. doi: 10.1016/j.berh.2008.02.001.
PMID: 18455690RESULTJevsevar DS, Brown GA, Jones DL, Matzkin EG, Manner PA, Mooar P, Schousboe JT, Stovitz S, Sanders JO, Bozic KJ, Goldberg MJ, Martin WR 3rd, Cummins DS, Donnelly P, Woznica A, Gross L; American Academy of Orthopaedic Surgeons. The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am. 2013 Oct 16;95(20):1885-6. doi: 10.2106/00004623-201310160-00010. No abstract available.
PMID: 24288804RESULTWang-Saegusa A, Cugat R, Ares O, Seijas R, Cusco X, Garcia-Balletbo M. Infiltration of plasma rich in growth factors for osteoarthritis of the knee short-term effects on function and quality of life. Arch Orthop Trauma Surg. 2011 Mar;131(3):311-7. doi: 10.1007/s00402-010-1167-3. Epub 2010 Aug 17.
PMID: 20714903RESULTWoolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14.
PMID: 14710506RESULTPark SI, Lee HR, Kim S, Ahn MW, Do SH. Time-sequential modulation in expression of growth factors from platelet-rich plasma (PRP) on the chondrocyte cultures. Mol Cell Biochem. 2012 Feb;361(1-2):9-17. doi: 10.1007/s11010-011-1081-1. Epub 2011 Sep 29.
PMID: 21956670RESULTKon E, Buda R, Filardo G, Di Martino A, Timoncini A, Cenacchi A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma: intra-articular knee injections produced favorable results on degenerative cartilage lesions. Knee Surg Sports Traumatol Arthrosc. 2010 Apr;18(4):472-9. doi: 10.1007/s00167-009-0940-8. Epub 2009 Oct 17.
PMID: 19838676RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Felix Vilchez Cavazos
- Organization
- Universidad Autonoma de Nuevo Leon
Study Officials
- PRINCIPAL INVESTIGATOR
Felix Vilchez, MD, PHD
Universidad Autonoma de Nuevo Leon
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Jose Felix Vilchez Cavazos
Study Record Dates
First Submitted
January 27, 2015
First Posted
February 25, 2015
Study Start
March 1, 2015
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
February 19, 2018
Results First Posted
February 19, 2018
Record last verified: 2017-08