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Two-year clinical outcomes of autologous microfragmented adipose tissue in elderly patients with knee osteoarthritis: a multi-centric, international study

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Abstract

Purpose

The aim of this study is to evaluate the outcomes of autologous microfragmented adipose tissue (MFAT) injection in elderly patients with knee osteoarthritis (OA). We hypothesized that MFAT knee infiltration for the treatment of knee OA would yield good clinical results out to two years follow-up.

Methods

Multi-centric, international, open-label study conducted by orthopedic surgery, and/or regenerative medicine facilities utilizing patient registries. Subjects recruited for eligibility. The primary outcome measure was Knee Injury and Osteoarthritis Outcome Score (KOOS). Outcomes and patient factors were compared to baseline, at six, 12, and 24 months. Statistical models were used to assess KOOS subscores and probability of exceeding the Minimally Clinically Important Difference (MCID) or Patient Acceptable Symptom State (PASS), and to assess the effect of the treatment variables on KOOS - Pain.

Results

Seventy-five patients, 120 primary treatments, mean age 69.6 years, (95%CI 68.3–70.9), BMI 28.4 (95%CI 27.3–29.6), with KL grade 2 to 4 knee OA treated with a single MFAT injection. KL grades 2 (15.1%), 3 (56.3%), and 4 (28.6%), with 20.8% of knees having previously undergone surgery. Patients with KL grade 2 disease had the best results in KOOS - Pain (P = 0.001), at six, 12, and 24 months. Including advanced KL grade 3 and 4 osteoarthritis patients, significant functional and quality of life success was seen in 106/120 treatments (88.3%, 66 patients) at all follow-up time points. Fourteen treatments (11.7%, 9 patients) failed prior to the study endpoint.

Conclusion

This study shows that a single-dose MFAT injection leads to clinical, functional, and quality of life improvement at two years in elderly patients, in KL grades 2 to 4 of knee osteoarthritis. These findings provide evidence that this treatment modality could be a safe and effective option to other commonly available treatments in carefully selected patients.

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Availability of data and material statement

Underlying data from this manuscript may be requested by qualified researchers upon request. Investigators may request access to deidentified patient data and redacted study documents which may include raw datasets, analysis-ready data sets, blank data forms. Prior to the use of data, proposals need to be approved by an independent review panel at www.clinicalstudyrequest.com and a signed data-sharing agreement will need to be executed. Some documents are available in Italian, and others in English.

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Acknowledgments

The authors would like to acknowledge Corey Scholes, EBM Analytics, and Nico Nagelkerke for their contribution to the statistical analysis of this work. The authors would also like to acknowledge Pam Jackson, PhD, for editorial contributions.

Funding

Self-funded.

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Authors and Affiliations

Authors

Contributions

All authors analyzed and/or interpreted data. All authors collaborated in the drafting and critical revision of the manuscript. All authors approved the final version of the manuscript and vouch for the accuracy of the analysis and the fidelity of the study to the protocol.

Corresponding author

Correspondence to William D. Murrell.

Ethics declarations

Consent to participate

All patients were approved for treatment by written informed consent.

Consent for publication

Written informed consent was obtained from all patients.

Competing interests

C.R.: Consultant, Lipogems, Inc.; Medical Director and shareholder, Personalized Stem Cells, Inc.; Co-Founder and shareholder, DataBiologics, Inc.

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Level of Evidence: Level 4

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Gobbi, A., Dallo, I., Rogers, C. et al. Two-year clinical outcomes of autologous microfragmented adipose tissue in elderly patients with knee osteoarthritis: a multi-centric, international study. International Orthopaedics (SICOT) 45, 1179–1188 (2021). https://doi.org/10.1007/s00264-021-04947-0

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