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Effectiveness of Arthrocentesis as Coadjuvant for Platelet-rich Plasma Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
Arthrocentesis
Platelet-Rich Plasma
Sponsored by
Universidad Nacional de Entre Rios
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Joint Lavage, Autologous Treatments, Public Health, Lower Extremity, Argentina

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Research and Development in Bioengineering and Bioinformatics (IBB-CONICET-UNER)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AC-PRP

S-PRP

Arm Description

Arthrocentesis followed by platelet-rich plasma

Platelet-rich plasma as standard of care

Outcomes

Primary Outcome Measures

Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire assesses the symptoms and physical disability of individuals with OA. The WOMAC consists of multiple-choice questions, and the responses are scored from zero to four. The final score is calculated between 0 and 96, where higher scores correspond to greater pain, stiffness, and lower functionality, indicating worsening symptoms.

Secondary Outcome Measures

Change in the the Lower Extremity Functional Scale (LEFS) Index
The Lower Extremity Functional Scale (LEFS) questionnaire is a self-administered questionnaire assessing functional status in patients with various lower limb musculoskeletal conditions, including OA. It consists of 20 items, each scored on a 5-point scale. The maximum possible score is 80, indicating the best functional level.
Change in Maximum Voluntary Isometric Contraction (MVIC) strength of the quadriceps
MVIC (maximum voluntary isometric contraction) strength of the quadriceps will be assessed using an instrumented load cell, which measures in kilograms. Objective and reliable assessment of muscle strength is well-supported for monitoring disease progression and evaluating therapeutic interventions. The test will involve asking the patient to extend the knee with maximum possible force for 3 seconds, ensuring that the hip and knee are at 90 degrees. Three repetitions will be performed with 2-minute rests.
Centre of pressure (COP) on the plantar surface of the foot
The measurement of plantar pressure pattern and COP will be performed using a foot-X AR-1 pressure platform. The patient will be positioned upright or anatomically on the platform for a period of time during which the application will record the pressure values. The measurement will be bipedal (both feet on the platform), so both an integral COP of both feet and an individual COP of each foot will be obtained.
Timed Up and Go (TUG) Test
The FTSTS and TUG tests are reliable and validated clinical tools that are used as predictors of health problems or disability. The first one consists of the time it takes to sit and stand five times in a row. The second one is similar, but adds a walk at a certain distance.
Five Times Sit to Stand (FTSTS) Test
The FTSTS and TUG tests are reliable and validated clinical tools that are used as predictors of health problems or disability. The first one consists of the time it takes to sit and stand five times in a row. The second one is similar, but adds a walk at a certain distance.

Full Information

First Posted
March 28, 2023
Last Updated
April 10, 2023
Sponsor
Universidad Nacional de Entre Rios
Collaborators
National Council of Scientific and Technical Research, Argentina
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1. Study Identification

Unique Protocol Identification Number
NCT05825105
Brief Title
Effectiveness of Arthrocentesis as Coadjuvant for Platelet-rich Plasma Treatment of Knee Osteoarthritis
Official Title
Efectividad Coadyuvante de la Artrocentesis en el Tratamiento Regenerativo Con Plasma Rico en Plaquetas (PRP) Para la disminución Objetiva Del Dolor y la recuperación Funcional Del Miembro Inferior en Osteoartritis de Rodilla
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Entre Rios
Collaborators
National Council of Scientific and Technical Research, Argentina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. In maxillofacial surgery, arthrocentesis (AC) has been used as a treatment for temporomandibular joint (TMJ) problems, including OA. Arthrocentesis involves flushing the joint with physiological solutions to remove pro-inflammatory particles responsible for pain. The use of AC in combination with PRP in the joint cavity has been studied, and the results have shown promising outcomes in terms of pain reduction and functional recovery of the joint. The primary objective of this study is to determine whether AC-PRP treatment results in better pain reduction and improved functionality compared to standard PRP treatment. The secondary objective is to explore the association between changes in LEFS questionnaire scores and/or maximal quadriceps isometric strength and possible clinical improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Joint Lavage, Autologous Treatments, Public Health, Lower Extremity, Argentina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AC-PRP
Arm Type
Experimental
Arm Description
Arthrocentesis followed by platelet-rich plasma
Arm Title
S-PRP
Arm Type
Active Comparator
Arm Description
Platelet-rich plasma as standard of care
Intervention Type
Procedure
Intervention Name(s)
Arthrocentesis
Intervention Description
The participant will then be asked to lie down in a comfortable position with the affected knee fully extended or flexed between 15 and 20 degrees, with a rolled towel under the knee. The periauricular skin surface will be disinfected with a povidone iodine solution, and an intra-articular local anesthetic with 1% lidocaine will be applied. A 21-gauge needle will be placed at the point of application. Arthrocentesis will be performed by injecting 10-50 mL of lactated Ringer's solution, followed by the extraction of articular fluid.
Intervention Type
Biological
Intervention Name(s)
Platelet-Rich Plasma
Intervention Description
The PRP will be prepared using a single centrifugation process. Approximately 30 ml of peripheral blood will be drawn and collected into a vacutainer tubes with sodium citrate anticoagulant 0.129 mol/l (3.8%). The tubes will then be centrifuged at 900 RPM for 12 minutes at room temperature in a benchtop centrifuge. We will separate the lower third of the plasma fraction from all tubes with a syringe and needle, taking care to avoid the leukocyte layer. The PRP will be refrigerated at 4°C for no less than 1 hour. We will not use any exogenous factors to stimulate the platelet activation process. The periauricular skin surface will be disinfected with a povidone iodine solution, and an intra-articular local anesthetic with 1% lidocaine will be applied. A 21-gauge needle will be placed at the point of application. Finally, PRP will be injected into the joint, and the needle will be removed.
Primary Outcome Measure Information:
Title
Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index
Description
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire assesses the symptoms and physical disability of individuals with OA. The WOMAC consists of multiple-choice questions, and the responses are scored from zero to four. The final score is calculated between 0 and 96, where higher scores correspond to greater pain, stiffness, and lower functionality, indicating worsening symptoms.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Secondary Outcome Measure Information:
Title
Change in the the Lower Extremity Functional Scale (LEFS) Index
Description
The Lower Extremity Functional Scale (LEFS) questionnaire is a self-administered questionnaire assessing functional status in patients with various lower limb musculoskeletal conditions, including OA. It consists of 20 items, each scored on a 5-point scale. The maximum possible score is 80, indicating the best functional level.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Title
Change in Maximum Voluntary Isometric Contraction (MVIC) strength of the quadriceps
Description
MVIC (maximum voluntary isometric contraction) strength of the quadriceps will be assessed using an instrumented load cell, which measures in kilograms. Objective and reliable assessment of muscle strength is well-supported for monitoring disease progression and evaluating therapeutic interventions. The test will involve asking the patient to extend the knee with maximum possible force for 3 seconds, ensuring that the hip and knee are at 90 degrees. Three repetitions will be performed with 2-minute rests.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Title
Centre of pressure (COP) on the plantar surface of the foot
Description
The measurement of plantar pressure pattern and COP will be performed using a foot-X AR-1 pressure platform. The patient will be positioned upright or anatomically on the platform for a period of time during which the application will record the pressure values. The measurement will be bipedal (both feet on the platform), so both an integral COP of both feet and an individual COP of each foot will be obtained.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Title
Timed Up and Go (TUG) Test
Description
The FTSTS and TUG tests are reliable and validated clinical tools that are used as predictors of health problems or disability. The first one consists of the time it takes to sit and stand five times in a row. The second one is similar, but adds a walk at a certain distance.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Title
Five Times Sit to Stand (FTSTS) Test
Description
The FTSTS and TUG tests are reliable and validated clinical tools that are used as predictors of health problems or disability. The first one consists of the time it takes to sit and stand five times in a row. The second one is similar, but adds a walk at a certain distance.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Schierloh, PhD
Phone
+5491131325656
Email
pablo.schierloh@uner.edu.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Facundo N Urteaga, PhD Student
Phone
+54113425110760
Email
facundo.urteaga@uner.edu.ar
Facility Information:
Facility Name
Institute for Research and Development in Bioengineering and Bioinformatics (IBB-CONICET-UNER)
City
Oro Verde
State/Province
Entre Ríos
ZIP/Postal Code
3100
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaston Schlottauer, PhD
Email
gaston.schlotthauer@uner.edu.ar

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effectiveness of Arthrocentesis as Coadjuvant for Platelet-rich Plasma Treatment of Knee Osteoarthritis

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