Nathan H Varady, Graham Cate, Ameen Barghi, Natalie Jobe, David Yakin, Ramon C Ylanan, Christopher A Arnold.
Varady NH, et al. Knee. 2020 Sep 23;27(5):1627-1634. | doi: 10.1016/j.knee.2020.08.018.
BACKGROUND: This study sought to assess early clinical outcomes for knee osteoarthritis (OA) patients undergoing bone marrow aspirate concentrate (BMAC) treatment using a novel closed-end, fenestrated trocar (FT) that does not require centrifugation.
METHODS: A prospective cohort of 17 knee OA patients undergoing BMAC treatment with the FT system from March 2018 to March 2019 was retrospectively evaluated. Approximately 10 mL of BMAC was harvested, no centrifugation was performed, and the BMAC was injected into the affected knee. Clinical outcomes were assessed at baseline, six weeks, and 12 weeks. This study has no affiliation with/vested-interest in the FT system.
RESULTS: There were significant improvements in nearly all outcomes from baseline to 12 weeks. Specific improvements included Knee Injury and OA Outcome Score (KOOS) activities-of-daily-living (61.1 ± 9.2 [mean ± 95% confidence interval] to 89.3 ± 6, p = 0.001), quality-of-life (32.7 ± 9.3 to 66.1 ± 17.9, p = 0.003), sports/recreation (36.9 ± 10.6 to 72.6 ± 26.3, p = 0.006), and pain (53.8 ± 9.3 to 83 ± 10.2, p = 0.001); Lysholm scores (55.5 ± 8.4 to 77.3 ± 10.5, p = 0.009); and visual analog pain scores (5.68 ± 1.14 to 2.07 ± 1.86, p = 0.003). Individually, at least 75% of patients exhibited improvement in all KOOS categories at six weeks and at least 85% at 12 weeks.
CONCLUSIONS: BMAC treatment with an FT system that does not require centrifugation resulted in significant improvements in early pain and function scores for knee OA. The symptomatic improvements in this study were similar to or greater than what has been reported using traditional needles. These data may provide clinicians with comfort in using an FT system and provide motivation for future randomized-controlled trials comparing aspiration techniques.
The Marrow Cellution™ System is designed to minimize and eliminate the restrictive limitations associated with “point of care” processing systems which employ inefficient traditional aspiration trocar technology and are regulated as drugs “Advanced Therapies Medicinal Products (ATMP)”. Marrow Cellution™ is a minimally invasive bone/cell enriched autograft access and retrieval system, which does not require additional manipulation or processing, it never leaves the sterile field and provides rich autograft without associated morbidity.
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