Clinical trial NCT05825105: Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis
Official title: Efectividad Del Plasma Rico en Plaquetas (PRP) Para la disminución Objetiva Del Dolor y la recuperación Funcional Del Miembro Inferior en Osteoartritis de Rodilla. Evaluación de Alternativas metodológicas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: Autologous Treatments
Public Health
Lower Extremity
Argentina
Real-world studies
Lead sponsor: Universidad Nacional de Entre Rios
Sponsor class: OTHER
Collaborators: name: National Council of Scientific and Technical Research, Argentina
First posted: 2023-04-24
Enrollment: 110
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is a disease that affects the joints of the body, causing pain, stiffness, and reduced mobility. To treat knee OA, a therapy called platelet-rich plasma (PRP) is used, which involves making a concentrated substance from the patient's own blood and injecting it into the joint. It has been shown that this therapy is effective in reducing pain; however, more research is needed to optimize the preparation and identify which patients are more receptive to the treatment. The primary objective of this study is to evaluate two modalities of PRP application and determine whether these treatments result in better pain reduction and improved functionality. The secondary objective is to explore the association between changes in LEFS questionnaire scores and/or maximal quadriceps isometric strength and possible clinical improvement.


Eligibility criteria: Inclusion Criteria:

* Radiological diagnosis of knee OA
* Age over 35 years old
* WOMAC value of 24 or higher at the time of recruitment

Exclusion Criteria:

* Patients with knee prosthesis, rheumatoid arthritis, contralateral lower limb amputation, any type of blood dyscrasia, hypofibrinogenemia, depot pool syndrome, or any other form of thrombocytopathy or chronic leukocytosis will be excluded from the study.
* Patients with anticoagulant or acute coagulopathies, as well as carriers of any infectious disease or superficial infection at the puncture site, will be temporarily excluded from the study until their clinical recovery is confirmed by laboratory testing.

Primary outcomes:
measure: Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Secondary outcomes:
measure: Change in the the Lower Extremity Functional Scale (LEFS) Index
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
measure: Change in Maximum Voluntary Isometric Contraction (MVIC) strength of the quadriceps
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
measure: Centre of pressure (COP) on the plantar surface of the foot
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
measure: Timed Up and Go (TUG) Test
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
measure: Five Times Sit to Stand (FTSTS) Test
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Other outcomes:
Locations:
city: Oro Verde
country: Argentina
facility: Institute for Research and Development in Bioengineering and Bioinformatics (IBB-CONICET-UNER)
state: Entre Ríos
Study officials:
References: