Single vs Triple Hyaluronic Acid in Knee Osteoarthritis

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.

NCT Number	NCT07352540
Lead Sponsor	University of Erlangen-Nürnberg Medical School Collaborators: Friedrich-Alexander-Universität Erlangen-Nürnberg
Conditions	Osteoarthritis, Knee
Enrollment	46 participants
Start Date	2026-01-15
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-14