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Journals & Clinical Evidence

Journals & clinical evidence: Orthopaedics & Pain

Curated research to understand technology benefits, comparisons, and limitations, prioritizing studies that identify devices or brands in our portfolio.

3 publications · Orthopaedics & Pain

Procedure evidence2017 · Brouwer PA et al.

PLDD vs microdiscectomy: two-year evaluation

Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

Multicentre randomised trial · Surgical candidates with contained disc herniation

Findings: A PLDD strategy with surgery when needed had non-inferior two-year outcomes compared with a microdiscectomy strategy. 48% of the PLDD group avoided surgery.

Points to consider: Reintervention was higher after PLDD: 52% versus 21%. Results apply to selected patients with herniation occupying less than one-third of the spinal canal.

Device & relevance: PLDD procedure research; a match to current biolitec device models has not been verified.

DOI: 10.1177/1591019917699981

General clinical evidence2020 · Garza JR et al.

SVF in knee osteoarthritis: placebo-controlled trial

Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial
The American journal of sports medicine

Double-blind randomised trial · 39 patients · Two SVF doses vs placebo

Findings: WOMAC symptom scores improved more in the SVF groups than with placebo through 12 months.

Points to consider: Small sample; MRI showed no change in cartilage thickness. Read alongside the larger MILES trial, which used different methods and comparators.

Device & relevance: The processing method in this study has not been matched to SONICSTEM; it is not direct evidence for the Cellabsys device.

DOI: 10.1177/0363546519899923

General clinical evidence2023 · Mautner et al.

MILES: cell therapy vs corticosteroids for the knee

Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial
Nature Medicine

Multicentre randomised trial · 480 participants · Grade II–IV knee osteoarthritis

Findings: At one year, SVF, bone marrow aspirate concentrate, and umbilical cord tissue-derived cells were not superior to corticosteroids for the primary pain outcome.

Points to consider: No significant change in MRI osteoarthritis scores was found. These findings cannot be generalized to all cell preparations or processing methods.

Device & relevance: General cell therapy evidence; not a SONICSTEM clinical trial.

DOI: 10.1038/s41591-023-02632-w