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Micro-fragmented stromal-vascular fraction plus microfractures provides better clinical results than microfractures alone in symptomatic focal chondral lesions of the knee

Knee Surgery, Sports Traumatology, Arthroscopy volume 28, pages 1876–1884 (2020)Cite this article

Abstract

Purpose

To evaluate clinical outcomes over a 1-year period in patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone.

Methods

Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee. At the end of surgery, in the experimental group, micro-fragmented stromal-vascular fraction was injected into the joint. Primary end point was WOMAC score at 12 months. Secondary end points were any adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption.

Results

All the patients were evaluated at 12-month follow-up. No adverse reactions were noted. Analgesic and anti-inflammatory consumption was similar in both groups. At 1-month follow-up, no differences were noted between groups when compared to pre-operative scores. At 3-month follow-up, patients in both groups improved from the baseline in all variables. Significantly lower VAS scores were found in the experimental group (4.2 ± 3.2 vs. 5.9 ± 1.7, p = 0.04). At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).

Conclusions

Injection of micro-fragmented stromal-vascular fraction is safe and, when associated with microfractures, is more effective in clinical terms than microfractures alone in patients affected by symptomatic focal chondral lesions of the knee. Results of the current study provide information that could help physicians to improve their counseling for patients concerning ADMSCs.

Level of evidence

Level 1—therapeutic study.

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Fig. 1
Fig. 2

Abbreviations

ADMSCs:

Adipose-derived mesenchymal stem cells

BMI:

Body mass index

CONSORT:

Consolidated Standards of Reporting Trials

EQ-5D:

EuroQol-5D

PRP:

Platelet-Rich Plasma

VAS:

Visual Analogue Scale

WOMAC:

Western Ontario & McMaster Universities Osteoarthritis Index

MCID:

Minimal Clinical Important Difference

MOCART:

Magnetic Resonance Observation of Cartilage Repair Tissue

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Authors and Affiliations

  1. Applied Biotechnologies and Translational Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy

    Salvatore Bisicchia

  2. Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy

    Salvatore Bisicchia, Gabriele Bernardi, Susanna M. Pagnotta & Cosimo Tudisco

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  1. Salvatore Bisicchia
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  2. Gabriele Bernardi
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  4. Cosimo Tudisco
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Contributions

SB has been involved in conception and design, analysis and interpretation of data, and drafting the manuscript. CT has been involved in conception and design, performed all the surgeries, and revised the manuscript critically for important intellectual content. GB and SMP have made substantial contributions to acquisition of data. All the authors have given final approval of the version to be published. They agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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Correspondence to Salvatore Bisicchia.

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Ethical approval was received from the University of Rome Tor Vergata Ethics Committee (Protocol LIPO 2 - approval number 8/16).

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Bisicchia, S., Bernardi, G., Pagnotta, S.M. et al. Micro-fragmented stromal-vascular fraction plus microfractures provides better clinical results than microfractures alone in symptomatic focal chondral lesions of the knee. Knee Surg Sports Traumatol Arthrosc 28, 1876–1884 (2020). https://doi.org/10.1007/s00167-019-05621-0

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  • DOI: https://doi.org/10.1007/s00167-019-05621-0

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