NCT07785401

Brief Summary

This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III). Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone. A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months. The primary endpoint is the between-group difference in change in knee pain measured using the Numeric Rating Scale (NRS) from baseline to Month 6. Secondary outcomes include changes in pain intensity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), quality of life measures, and safety assessments throughout the follow-up period. Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
23mo left

Started Jul 2026

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress6%
Jul 2026Jul 2028

Study Start

First participant enrolled

July 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Knee OsteoarthritisKnee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)Osteoarthritis (OA) of the Knee

Keywords

hyaluronic acidplatelet-rich plasmaPRPHAintra-articular injectionSingle intra-articular injectionknee osteoarthritisviscosupplementationHyaluronic acid and platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

  • Change in knee pain intensity on the Numeric Rating Scale (NRS)

    The Numeric Rating Scale (NRS) for pain is an 11-point single-item scale on which the participant rates knee pain intensity over the past week from 0 (no pain) to 10 (worst imaginable pain). The outcome is the between-group difference in change from baseline; a greater decrease indicates greater improvement.

    Baseline to 6 months]

Secondary Outcomes (6)

  • Change in knee pain intensity as measured by the Numeric Rating Scale (NRS) at additional time points

    Baseline, 1, 3, 12 and 18 months

  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores

    Baseline, 1, 3, 6, 12 and 18 months

  • Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale scores

    Baseline to 18 months

  • Number of participants with at least one treatment-emergent adverse event (AE)

    Baseline to 18 months

  • Number of treatment-emergent adverse events (AEs)

    Baseline to 18 months

  • +1 more secondary outcomes

Study Arms (2)

Hyaluronic acid with autologous plateletrich plasma

EXPERIMENTAL

Single intra-articular knee injection of 3.8 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP), prepared from 13.5 mL of the participant's venous blood using the PRP separation device (total injection volume: 4.8 mL).

Device: Hyaluronic Acid (HA) and Platelet rich plasma (PRP)

Hyaluronic acid

ACTIVE COMPARATOR

Single intra-articular knee injection of 4.8 mL hyaluronic acid gel containing sodium hyaluronate (25 mg/mL; total dose: 120 mg).

Device: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) and Platelet rich plasma (PRP)DEVICE

Procedure kit enabling preparation of autologous platelet-rich plasma (PRP) from the participant's venous blood and intra-articular administration combined with sodium hyaluronate. The procedure includes preparation of PRP using a separation device and injection of a total volume of 4.8 mL consisting of 3.8 mL of 2.5% sodium hyaluronate and 1 mL of autologous PRP.

Hyaluronic acid with autologous plateletrich plasma
Hyaluronic Acid (HA)DEVICE

Pre-filled syringe containing 4.8 mL of sterile, nonpyrogenic hyaluronic acid gel for intra-articular injection. The product contains sodium hyaluronate at a concentration of 25 mg/mL (total dose: 120 mg), produced by bacterial fermentation and of non-animal origin.

Hyaluronic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis meeting American College of Rheumatology (ACR) criteria
  • Kellgren-Lawrence radiographic grade II or III
  • Pain intensity in the study knee NRS \>= 4 and in the contralateral knee NRS \<= 2
  • Written informed consent

You may not qualify if:

  • BMI \>= 40 kg/m2
  • Surgery of the same or contralateral knee within the previous year
  • Intra-articular corticosteroid injection into the study joint within 3 months, or hyaluronic acid, platelet-rich plasma or other intra-articular injection therapy within 6 months before enrolment
  • Systemic corticosteroid use within 2 weeks
  • Systemic inflammatory or autoimmune disease with joint involvement (rheumatoid arthritis, spondyloarthropathy, systemic lupus erythematosus, etc.)
  • Oral corticosteroid treatment
  • Deep vein thrombosis
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life Medical Center

Warsaw, Masovian Voivodeship, 00-855, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Urszula Zdanowicz, MD

    Life Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliza Fiedorczuk

CONTACT

+48 58 660 44 88clinical@implai.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)