Poster Presentation Sydney Spinal Symposium 2024

Personalised Spinal Surgery for Australians: Clinical Study and Systematic Review (#35)

William CH Parr 1 , Jack Hill 1 , Ralph Mobbs 2 , Kevin Seex 3 , Marc Coughlan 4 , Chloe Amaro 1 , Jessica Wind 1 , Charles Furtado 1 , Adam Schuman 1 , Mai Beathyate 1 , John Ward 1 , William Walsh 5
  1. 3DMorphic, Matraville, NSW, Australia
  2. Neurosurgery, Prince Of Wales Private, Randwick, NSW, Australia
  3. Neurosurgery, Macquarie Neurosurgery, Macquarie Park, NSW, Australia
  4. Neurosurgery, Gosford Private Hospital, Gosford, NSW, Australia
  5. Medicine, UNSW, Randwick, NSW, Australia

Introduction

Lewin et al (2021) reported ~23% reoperation rate within 2 years of spinal fusion surgery. There is a need to improve spinal fusion outcomes and reduce revision surgeries.

A recent US study using Patient Specific Implants (PSI) for complex adult spinal deformity demonstrated better immediate achievement of alignment goals compared to stock devices but did not report clinical results. There is a lack of clinical evidence from statistically significant patient cohorts treated with PSI.

We report clinical results for Australian patients treated with anterior column lumbar PSI. For comparative purposes, we performed a systematic review of peer-reviewed literature and an analysis of the Australian Spine Registry (ASR).

Methods

We performed a systematic review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. We then analysed the ASR Quality of Life (QoL) data to calculate QoL index (0-1) scores.

This study reports on a multi-centre, multi-surgeon, post-market study of patients with lumbar Degenerative Disc Disease (DDD) and associated pathologies, necessitating discectomy and fusion. Pre-operative and post-operative (6, 12 and 24-month) clinical data were collected.

Results

The literature search yielded 4272 results. Results were sub-divided into 4 groups based on cage/fusion technique.

For the investigational group, our planned accrual target was 40 patients. We report results for 65 patients, of which 42 have data with follow up > 12 months. So far, there have been no reported revisions, biocompatibility issues or mechanical failures of PSI devices. Mean VAS improved significantly (p<0.01) from 7.91 (1.59 SD) pre-operatively to 1.91 (1.90 SD) at 24-months post-operatively. Mean QoL index scores improved significantly (p<0.01) from pre-operative 0.301 (0.263 SD) to 0.785 (0.200 SD) at 24 months.

Conclusions

The results show that PSI are a safe and effective treatment of DDD. As fusion techniques have advanced over time, clinical outcomes have also improved. The results from this study suggest PSI represent a new progression in reducing pain and improving QoL for patients.