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Total hip replacement rate in a cohort of patients affected by symptomatic hip osteoarthritis following intra-articular sodium hyaluronate (MW 1,500–2,000 kDa) ORTOBRIX study

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Abstract

Hip osteoarthritis is very common and costly. The European League Against Rheumatology Committee agenda asks for research to investigate treatments able to slow down the progression of hip osteoarthritis (OA), to delay joint replacement, and to determine the comparative effectiveness and cost-effectiveness of non-surgical and surgical treatment modalities as well as criteria relating to the indications for and timing of total hip replacement (THR). After publishing the results of a randomized controlled trial and a cohort study on the efficacy of Intra-articular sodium hyaluronate (MW 1,500–2,000 kDa) on symptomatic hip OA, we performed this retrospective study in patients suffering from hip OA treated with ultrasound-guided intra-articular injections of HyalOne (Hyalubrix 60 Italian brand name) involving a group of THR expert orthopedic surgeons to appraise whether or not considered eligible for THR and the frequency and timing of THR. Six orthopedists, not routinely performing hip intra-articular injections, each independently assessed whether 176 patients suffering from hip OA and treated with ultrasound-guided intra-articular injections of sodium hyaluronate (MW 1,500–2,000 kDa) were candidates for THR according to the clinical data (age, body mass index, Pain Visual Analog Scale, Lequesne Algofunctional Index, global patient assessment, global physician assessment, nonsteroidal anti-inflammatory drug intake, and hip X-ray) collected at the first intra-articular sodium hyaluronate injection visit and provided as anonymous electronic data. At 24 months, 159 out of 76 (90 %) patients did not undergo to THR. At 48 months, 82 % (N = 144) of the study population treated with intra-articular hyaluronic acid avoided THR. In the group of 93 patients considered candidates for THR (that is, in which 4, 5, or 6 orthopedic surgeons agreed that the patient was a suitable candidate for THR), only 17 had undergone THR, with survival results of 82 % at 24 months. At 48 months, this percentage reduced to 66 % in this group. In the other groups of patients (in which respectively 3, 2, 1 or no surgeons were in agreement that the patient was a candidate for THR) arthroplasty is not recorded. Sodium hyaluronate (MW 1,500–2,000 kDa) given by ultrasound-guided injection seems to delay THR in the real context of actual overall management of symptomatic hip OA patients. Although further studies are necessary to confirm these data and to identify outcome predictors, hip viscosupplementation should be considered as conservative treatment to perform before proposing patients for THR.

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Abbreviations

ACR:

American College of Rheumatology

BMI:

body mass index

CI:

confidence interval

NSAID:

nonsteroidal anti-inflammatory drug

OA:

osteoarthritis

RCT:

randomized controlled trial

ROC:

Receiver Operating Characteristic

VAS:

Visual Analog Scale

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Acknowledgments

The authors are grateful to Nicola Giordan for his help in the preparation of this manuscript and to Ilaria Panni for her precious assistance. Data collection and analysis, reporting, and writing of this study were supported by a grant from Fidia Farmaceutici S.p.A. No equipment or other supplies were provided by Fidia Farmaceutici S.p.A.

Disclosures

None.

Author information

Authors and Affiliations

  1. Operative Unit of Rheumatology, San Pietro Fatebenefratelli Hospital-Research Center, Via Cassia 600, 00189, Rome, Italy

    Alberto Migliore, Umberto Massafra & Emanuele Bizzi

  2. Istituto Superiore di Sanità, Rome, Italy

    Antonino Bella

  3. First Orthopedics Department, CTO Hospital, Rome, Italy

    Massimariano Bisignani

  4. Operative Unit of Orthopedics, San Pietro Fatebenefratelli Hospital, Rome, Italy

    Michele Calderaro

  5. Operative Unit of Orthopedics and Traumatology, San Salvatore Hospital, Pesaro, Italy

    Daniele De Amicis

  6. Department of Orthopedics, S. Cuore Catholic University, Rome, Italy

    Giandomenico Logroscino

  7. Operative Unit of Orthopedics and Traumatology, Policlinico Casilino, Rome, Italy

    Fabio Mariottini

  8. Department of Musculoskeletal system sciences, University of Rome “La Sapienza”, Rome, Italy

    Oreste Moreschini

  9. Operative Unit for Autoimmune Diseases, “La Sapienza” University, Rome, Italy

    Bruno Laganà

  10. ISBEM Research Center, Brindisi, Italy

    Prisco Piscitelli

  11. Department of Radiology, San Pietro Fatebenefratelli Hospital, Rome, Italy

    Sandro Tormenta

Authors
  1. Alberto Migliore
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  2. Antonino Bella
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  3. Massimariano Bisignani
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  4. Michele Calderaro
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  6. Giandomenico Logroscino
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  7. Fabio Mariottini
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  9. Umberto Massafra
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  10. Emanuele Bizzi
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  11. Bruno Laganà
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  12. Prisco Piscitelli
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  13. Sandro Tormenta
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Corresponding author

Correspondence to Alberto Migliore.

Appendices

Appendix

What is already known about this subject

  • Osteoarthritis is a major cause of disability worldwide. Over the past years, interest has grown among the scientific community, pharmaceutical companies, and regulatory agencies in the development of drugs that might influence the natural history of structural changes in OA by preventing, retarding, or reversing cartilage breakdown and the often related THR.

  • THR may still have potential—even important—consequences: infections, thromboembolism, implant dislocation, and damaged nerves and vessels.

  • In addition, THR is further complicated by a certain mortality rate: reported rate in Italy is >2 % in the 3 months following surgery. In addition to the direct consequences of the surgical procedure, another relevant, influencing factor is the time and activities required to achieve complete functional recovery.

  • The published data suggest that viscosupplementation may be effective in the symptomatic treatment of Hip OA.

What this study adds

  • Thanks to this study among patients with hip OA pain, being treated with intra-articular injection of HA and evaluated by orthopedic surgeons, we can confirm that viscosupplementation with hyaluronic acid seems to be a valuable technique for the management of painful OA of the hip that may delay the need for surgical intervention.

  • The results show that the treatment with hyaluronic acid (MW 1,500–2,000 kDa) is the most favorable option, from a clinical and economic perspective and also considering the social impact, since it helps preserve the survival rate to THR, and it helps provide the foundation for significant cost-savings.

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Migliore, A., Bella, A., Bisignani, M. et al. Total hip replacement rate in a cohort of patients affected by symptomatic hip osteoarthritis following intra-articular sodium hyaluronate (MW 1,500–2,000 kDa) ORTOBRIX study. Clin Rheumatol 31, 1187–1196 (2012). https://doi.org/10.1007/s10067-012-1994-4

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  • DOI: https://doi.org/10.1007/s10067-012-1994-4

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