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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis

NCT07352540 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-14

No results posted yet for this study

Summary

The goal of this clinical trial is to directly compare two hyaluronic acid injection protocols in adults with knee osteoarthritis: a single intra-articular injection of Innoryos 2.5% (Single-Shot) and a three-week injection series of Innoryos 2.2% (Triple-Shot). The study aims to determine whether the single injection provides comparable safety, pain relief, and improvement in knee function to the triple-injection protocol.

The main questions are:

* How do the single-shot and triple-shot protocols compare in terms of pain reduction and functional improvement?
* How do their safety and tolerability profiles compare?
* What medical problems occur with each protocol? Participants (n = 46) will receive either the single 4.8 ml injection or three weekly 2 ml injections. They will attend clinic visits at baseline, Week 6, Week 12, and Week 24 for assessments including WOMAC score, 7-day pain diary, functional and strength tests, and MRI scans of the knee.

This single-center, partially blinded, randomized study will provide a direct comparison of the two HA injection protocols, assessing whether the single-shot approach is as safe and effective as the triple-shot regimen, while potentially offering a more convenient, patient-friendly treatment.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Three intra-articular hyaluronic acid (HA) injections

Therapy with intra-articular injections of hyaluronic acid (HA). Three intra-articular injections of Innoryos 2.2% (2 ml per injection) administered into the affected knee joint at weekly intervals.

DRUG

One intra-articular hyaluronic acid (HA) injection

Therapy with a single intra-articular injection of hyaluronic acid (HA). One intra-articular injection of Innoryos 2.5% (4.8 ml per injection) administered into the affected knee joint at weekly intervals.

Sponsors & Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    collaborator OTHER

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Simon von Stengel, PhD · Institute of Radiology, University Hospital Erlangen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-08-01
Completion
2026-09-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352540 on ClinicalTrials.gov