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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

  • Salvatore BisicchiaEmail author
  • Gabriele Bernardi
  • Susanna M. Pagnotta
  • Cosimo Tudisco
KNEE
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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.

Keywords

Stromal-vascular fraction Adipose-derived mesenchymal stem cell Chondral lesion Knee 

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

Notes

Author 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.

Funding

No funding was used.

Compliance with ethical standards

Conflict of interest

The authors have no potential conflict of interest.

Ethical approval

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

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Copyright information

© European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2019

Authors and Affiliations

  1. 1.Applied Biotechnologies and Translational MedicineUniversity of Rome Tor VergataRomeItaly
  2. 2.Department of Orthopaedic Surgery, Sports Traumatology UnitUniversity of Rome Tor VergataRomeItaly

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