Level C· Early human research exploring benefitsProspective StudyEurope PMCOpen access

Oral Presentations

Cannestra A., Schroerlucke S., Wang M., Good C., Lim J., Hsu V.

Prospective Study with a reported sample of 4 on Ligament Injury, Back Pain, Disc Degeneration, Spinal Cord Injury, published in Global Spine Journal (2018) — summary generated from the PubMed abstract.

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Level C· Early human research exploring benefitsEvidence level of this study

Early human evidence such as case series or small samples is exploring possible benefits.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Prospective Study
Journal
Global Spine Journal (2018)
Reported sample size
4
Source database
Europe PMC
PMCID
PMC6152593

Abstract (original English)

Introduction: As robotic-guidance and minimally invasive approaches become more prevalent in spine surgery, there is a growing interest in high-level scientific evidence of their clinical value. MIS ReFRESH is the first prospective, comparative, multi-center study designed to assess differences in surgical complication and revision rates, and exposure to intra-operative radiation, in adult degenerative conditions, operated in a minimally invasive (MIS) approach in 1-to-3 level fusions. Materials and Methods: Multicenter data (9 sites) were prospectively collected from 379 adult patients indicated for fusion surgery, including demographics, complications, need for revision surgery and use of intra-operative fluoroscopy (in seconds). A single site randomized patients between arms, while other sites enrolled exclusively to one arm. We compared of incidence of revision surgeries and clinical complications (surgical and medical) through a logistic regression model (Cox) as well as intra-operative fluoroscopy use. Results: Altogether, 9 sites enrolled 379 cases: 287 in the robot-guided arm (RG), and 92 in the fluoro-guided arm (FG). One site randomized patients, 15 to RG and 11 to FG. Mean age of RG patients was 59.1 years vs. 62.4 for FG (p = 0.032) and BMI was 31.4 vs. 28.0, respectively (p Conclusion: We report our findings from a prospective, multi-center, comparative study of MI

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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