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HYADD 4 versus methylprednisolone acetate in symptomatic knee osteoarthritis: a single-centre single blind prospective randomised controlled clinical study with 1-year follow-up

1, 2, 3


  1. Department of Orthopaedic Surgery, University of Rome Tor Vergata, Italy.
  2. Department of Orthopaedic Surgery, University of Rome Tor Vergata, Italy.
  3. Department of Orthopaedic Surgery, University of Rome Tor Vergata, Italy.

2016 Vol.34, N°5
PI 0857, PF 0863
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PMID: 27244700 [PubMed]

Received: 30/10/2015
Accepted : 08/02/2016
In Press: 31/05/2016
Published: 16/09/2016


The aim of the present study was to compare the clinical results and the quality of life in patients with symptomatic knee osteoarthritis randomised to either a new HA (HYADD 4) or corticosteroid (CS). A separate rationale was to evaluate the safety profile of HYADD 4.
All the patients presenting for unilateral symptomatic primary knee osteoarthritis were prospectively randomly assigned to receive 2 injections of either HYADD 4 or CS, and were evaluated before the injections and at 6, 12, 26 and 52 weeks. Primary end point was WOMAC score at 26 weeks; secondary end points were WOMAC score, VAS for pain, and SF-36 score at any time point.
There were 53 females and 22 males in the HYADD 4 group (mean age 71.5±10.6 years), and 50 females and 25 males in the CS group (mean age 68.6±9.9 years). The observed sided effects were mild and their incidence was similar in the two groups. Patients in the HYADD 4 group reported significantly better WOMAC scores at 26 weeks. The patients improved in all considered outcomes after the injections, with a peak of therapeutic effect between 6 and 12 weeks. Patients in the HYADD 4 group obtained significantly better scores than the CS group up to 26 weeks. At the 1-year follow-up no statistically significant differences between treatments were detected.
HYADD 4 did not have significantly higher side effects when compared to CS injections and provided better short-term (but not long-term) control of symptoms in patients with mild to moderate knee osteoarthritis. Patients with less pain and dysfunction at baseline may be the best candidates for HYADD 4 injections.

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