Knee Osteoarthritis Treatment With Platelet-rich Plasma

NCT05824806 | Not Yet Recruiting Phase 3

• 1 other identifier: 60887422.4.0000.5273
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (KOA) is a disease characterized by cartilage degeneration, synovium inflammation, bone remodeling, osteophyte formation, inflammations and loss of articular function. Interest on biological therapies has increased due to the recent update on KOA and its natural history. Viscosupplementation with hyaluronic acid aims to restore rheological properties of synovial fluid. Platelet rich plasma (PRP) is an autologous blood product which contains an elevated platelet concentration above the one found in blood. The goal of this study is to compare the clinical results of intra articular infiltration of hyaluronic and platelet rich plasma in the treatment of KOA, and to establish a protocol for PRP obtaining and prepare. Patients form the OA treating program will be selected and randomized into three groups (treatment with hyaluronic acid or onte of the two PRP protocols, PRP A and PRP B). Evaluation will include: subjective functional evaluation, clinical evaluation, radiological evaluation and radiological evaluation, which will be performed before treatment and 3 weeks, 3 months, 6 months and 1 year after treatment. Evaluation of PRP composition will be performed using ELISA/LUMINEX. Key words: Knee, osteoarthritis, platelet rich plasma, viscosupplementation.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; platelet rich plasma; hyaluronic acid; knee

Outcome Measures

Primary Outcomes (3)

• Evolution of Western Ontario and McMaster Universities Arthritis Index over time

  Subjective pain and function score changes

  before infiltration, two weeks after first infiltration, three months, six months and one year after last infiltration

• Evolution of Knee society score over time

  Subjective function score changes

  before infiltration, two weeks after first infiltration, three months, six months and one year after last infiltration

• Evolution of Visual analog pain scale over time

  Subjective pain scale changes

  before infiltration, two weeks after first infiltration, three months, six months and one year after last infiltration

Study Arms (3)

PRP protocol A

ACTIVE COMPARATOR

Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma (PRP A), once a week, for three consecutive weeks

Biological: PRP Protocol A

PRP protocol B

ACTIVE COMPARATOR

Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma (PRP B), once a week, for three consecutive weeks

Biological: PRP Protocol B

Hyaluronic acid

PLACEBO COMPARATOR

Composed of 30 patients who will receive an intra-articular injection of 2 mL of intra-articular hyaluronic acid (AHI), once a week, for three consecutive weeks.

Device: Hyaluronic acid

Interventions

PRP Protocol A BIOLOGICAL

Platelet rich plasma protocol A

PRP protocol A

PRP Protocol B BIOLOGICAL

Platelet rich plasma protocol B

PRP protocol B

Hyaluronic acid DEVICE

Hyaluronic acid

Hyaluronic acid

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Will be included in the study:
• Patients aged between 40 and 60 years
• Patients with bilateral osteoarthritis of the knee according to the criteria of the American College of Rheumatology
• Patients classified by radiographs using the Kellgren-Lawrence classification ≤ III in both knees
• Patients showing complete knee range of motion (0 to 120°).

You may not qualify if:

• Will be excluded from the study:
• Patients with a history of trauma, infection or previous surgery in the joint involved
• Patients with axial deviation of the lower limbs (varus greater than 10° or valgus greater than 15°)
• Patients with previous infiltration of the knee with corticosteroids in the last six months
• Patients with previous infiltration of the knee with hyaluronic acid in the last year
• Patients with inflammatory, autoimmune or rheumatic diseases
• Patients who used non sterois anti inflammatory drugs in the previous two weeks
• Patients with body mass index\>35 kg/m2
• Patients using immunosuppressants or anticoagulants
• Patients with active neoplasia
• Patients with hematologic disorders
• Patients with secondary osteoarthritis
• Patients with hip osteoarthritis
• Patients with history of acute or chronic transmissible diseases
• Patients residing outside the metropolitan region of Rio de Janeiro.

Sponsors & Collaborators

• Instituto Nacional de Traumatologia e Ortopedia: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, 20940-070, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eduardo B Sousa, MD, PhD

  INTO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo B Sousa, MD, PhD

CONTACT

+55212134-5609; esousa@into.saude.gov.br

Marcelo Mandarino, MD, MSc

CONTACT

+552121345000

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be randomized in block by simple drawing of opaque envelopes before application, in 3 experimental groups. During infiltration, patients will be sitting on the stretcher in a comfortable position, with knees flexed and blindfolded (blinding as to the treatment performed). Patients will be evaluated by an observer independent of the one who applied the selected treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients will be randomized in blocks by simple drawing of opaque envelopes before application, in 3 experimental groups, and identified as described below: GROUP A: Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma (PRP A), once a week, for three consecutive weeks; GROUP B: Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma (PRP B), once a week, for three consecutive weeks; GROUP C: Composed of 30 patients who will receive an intra-articular injection of 2 mL of intra-articular hyaluronic acid (AHI), once a week, for three consecutive weeks.

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 24, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)