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  • Knee osteotomy combined with meniscal allograft transplantation versus knee osteotomy alone in patients with unicompartmental knee osteoarthritis: a prospective double-blind randomised controlled trial protocol

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Surgery
Protocol
Knee osteotomy combined with meniscal allograft transplantation versus knee osteotomy alone in patients with unicompartmental knee osteoarthritis: a prospective double-blind randomised controlled trial protocol
  1. Lorenzo Zanasi1,
  2. Angelo Boffa1,
  3. Luca De Marziani1,
  4. Gina Lisignoli2,
  5. Claudio Belvedere3,
  6. Marco Miceli4,
  7. Stefano Zaffagnini1,
  8. Giuseppe Filardo5,
  9. Alessandro Di Martino1,6
  1. 1Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
  2. 2Laboratorio di Immunoreumatologia e Rigenerazione Tissutale, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
  3. 3Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
  4. 4Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
  5. 5Faculty of Biomedical Sciences, Università della Svizzera italiana, Lugano, Ticino, Switzerland
  6. 6Applied and Translational Research (ATR) Center, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
  1. Correspondence to Dr Angelo Boffa; angelo.boffa{at}ior.it

Abstract

Introduction Knee osteotomy combined with meniscal allograft transplantation (MAT) showed promising results to treat unicompartmental knee osteoarthritis (OA) secondary to meniscal deficiency and knee malalignment. However, there is still no high-level evidence to demonstrate whether the combination of these two treatments is superior to osteotomy alone.

Methods and analysis 52 patients with unicompartmental knee OA Kellgren-Lawrence grade ≤3 secondary to meniscal deficiency and knee malalignment (aged 20–60 years) are randomised to undergo knee osteotomy associated with MAT or knee osteotomy alone in a 1:1 ratio. The primary outcome is the International Knee Documentation Committee (IKDC) subjective score at 12 months. The secondary outcomes are the IKDC subjective score at 1, 3 and 6 months, the Western Ontario and McMaster Universities Osteoarthritis Index score, the Knee Injury and Osteoarthritis Outcome Score, the Visual Analogue Scale, the EuroQol Visual Analogue Scale, the Tegner Activity Level Scale, objective parameters (transpatellar circumference, suprapatellar circumference and range of motion), patient expectation on treatment efficacy and patient satisfaction at 1, 3, 6 and 12 months. Radiographs are performed at baseline and at 1-, 6- and 12-month follow-ups and magnetic resonance evaluations at baseline and at 12 months. Biomechanical assessment is performed through gait analysis before surgery and at 12 months, investigating motion data, biomechanical parameters and muscle activation through electromyography. In addition, to detect early joint environment changes and potential MAT effects in protecting the articular surface providing a better knee homeostasis, biological markers of cartilage turnover and inflammation obtained from synovial fluid, serum and urine are evaluated at baseline and at 24 hours, 1-, 3-, 6- and 12-month follow-ups.

Ethics and dissemination The study protocol has been approved by Emilia Romagna’s Ethics Committee (CE-AVEC), Bologna, Italy. Written informed consent is obtained from all participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Protocol version March 2023.

Trial registration number NCT05840887.

  • Knee
  • Randomised Controlled Trial
  • Patient Reported Outcome Measures
  • Gait Analysis
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2024-087552

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    Footnotes

    • Contributors ADM is the principal investigator of this study and acted as guarantor. LZ and AB wrote the manuscript; LZ, AB, LDM, SZ and ADM will conduct the trial. MM is responsible for imaging evaluation. GL is responsible for biological analyses. CB is responsible for biomechanical analyses. ADM, SZ and GF applied for funding and supervise the trial. All authors read and approved the final protocol.

    • Funding This study is funded by the Italian Ministry of Health in the Project ‘Ricerca Finalizzata’ (RF-2021-12374767) ‘BIOlogical and BIOmechanical changes after Meniscus Allograft Transplantation in osteoarthritic patients treated with knee osteotomy – BIOMAT’.

    • Competing interests SZ has received institutional support from FidiaFarmaceutici S.p.A., Cartiheal, IGEA Clinical Biophysics, BIOMET and Kensey Nash; grant support from I+ SRL; and royalties from Springer outside the submitted work. The principal investigator and the other authors declare no financial or competing interest.

    • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.