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NOT YET RECRUITING
NCT07352540
PHASE2/PHASE3

Single vs Triple Hyaluronic Acid in Knee Osteoarthritis

Sponsor: University of Erlangen-Nürnberg Medical School

View on ClinicalTrials.gov

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.

Official title: Effects and Safety of Single Versus Triple Hyaluronic Acid Injections in the Treatment of Knee Osteoarthritis

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-02-01

Completion Date

2026-08-01

Last Updated

2026-01-20

Healthy Volunteers

No

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.