Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma

NCT06520059 | Not Yet Recruiting Phase 4

• 1 other identifier: 001-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective cohort clinical study. Due to logistic constraints at the sites of implementation, a randomized allocation will not be feasible (private clinic). Patients will be selected with the aim of matching for important confounders (sex and age) the grade of knee OA will be restricted to advance stages.

Conditions

Knee Osteoarthritis

Keywords

Injections, Intra-Articula;; Regenerative Medicine;; Cartilage Repair

Outcome Measures

Primary Outcomes (2)

• PROM - Knee related Qol

  Knee injury and Osteoarthritis Outcome Score (KOOS) - absolute value from the score (units). Min-Max (0-100) higher scores indicate better outcomes and a higher quality of life related to the knee

  baseline, and at follow-up of 3 months, 6 months and 12 months

• PROM - PAIN

  Visual analogic Score - PAIN (VAS) -absolute value from the score (units). Min-Max (0-10) higher scores indicate worse outcomes

  baseline, and at follow-up of 3 months, 6 months and 12 months

Secondary Outcomes (2)

• bone marrow edema -MRI

  1 month prior to the injection; 1 month to one year after intervention

• bone marrow edema -MRI

  1 month prior to the injection; 1 month to one year after intervention

Study Arms (2)

Intraosseous and intra-articular PRP

ACTIVE COMPARATOR

Two intraosseous injections of PRP and another intra-articular injection of PRP on the same day.

Combination Product: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration

Intra-articular PRP

ACTIVE COMPARATOR

Patients submited to two intra-articular injections of PRP, separated by one week.

Combination Product: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration

Interventions

Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration COMBINATION_PRODUCT

Group 1 will receive two intraosseous injections of PRP and a subsequent/synchronous intra-articular injection of PRP on the same day. Group 2 will only receive two intra-articular injections of PRP, separated by one week.

Intra-articular PRP; Intraosseous and intra-articular PRP

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult individuals with unilateral or bilateral symptomatic knee OA diagnosis according to the American College of Rheumatology
• with symptoms for more than 3 months
• confirmed with radiologic diagnosis (Kellgren-Lawrence grades III or IV).
• Patients must be able to walk with a painful knee.

You may not qualify if:

• previous history of knee surgery
• systemic autoimmune or rheumatic disease
• platelet diseases
• use of NSAIDs 3 days prior the injections
• previous history (last 3 months) of systematic use of corticosteroids
• or other intra-articular injections in the knee in the past 6 months

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (2)

Faculdade de Medicina da Universidade do Porto

Porto, 4200 - 319, Portugal

Location

Faculdade de Medicina da Universidade do Porto

Porto, 4200-319, Portugal

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: In this study, blinding (masking) will be applied to the outcome assessors. Patients will notice which specific type of PRP injection (intraosseous or intra-articular) they are receiving. Outcome assessors who evaluate the VAS scores, KOOS, and MRI results will also be blinded to the group assignments to prevent bias in the assessment of the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSC, MPH, PHD, FEBVS

Model Details: This study is a prospective cohort, parallel design clinical trial comparing the efficacy of intraosseous versus intra-articular injections of PRP for treating advanced knee osteoarthritis. Patients are matched for sex and age, and outcomes are assessed using VAS scores, KOOS, and MRI evaluations over a 12-month period. The study aims to determine which injection method provides superior pain relief and functional improvement.

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 25, 2024
• Study Start: January 1, 2025
• Primary Completion: July 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)