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1. Accuracy of 3D printed spine models for pre-surgical planning of complex adolescent idiopathic scoliosis (AIS) in spinal surgeries: a case series

Author

Abir Dutta, Menaka Singh, Kathryn Kumar, Aida Ribera Navarro, Rodney Santiago, Ruchi Pathak Kaul, Sanganagouda Patil, and Deepak M Kalaskar

Subjects
Adolescent idiopathic scoliosis, 3D Printing, 3D Reconstruction, Surgical planning, Additive manufacturing, Medical technology, R855-855.5
Abstract

Adolescent idiopathic scoliosis (AIS) is a noticeable spinal deformity in both adult and adolescent population. In majority of the cases, the gold standard of treatment is surgical intervention. Technological advancements in medical imaging and 3D printing have revolutionised the surgical planning and intraoperative decision making for surgeons in spinal surgery. However, its applicability for planning complex spinal surgeries is poorly documented with human subjects. The objective of this study is to evaluate the accuracy of 3D printed models for complex spinal deformities based on Cobb angles between 40° to 95°.This is a retrospective cohort study where, five CT scans of the patients with AIS were segmented and 3D printed for evaluating the accuracy. Consideration was given to the Inter-patient and acquisition apparatus variability of the CT-scan dataset to understand the effect on trueness and accuracy of the developed CAD models. The developed anatomical models were re-scanned for analysing quantitative surface deviation to assess the accuracy of 3D printed spinal models. Results show that the average of the root mean square error (RMSE) between the 3DP models and virtual models developed using CT scan of mean surface deviations for the five 3d printed models was found to be 0.5±0.07 mm. Based on the RMSE, it can be concluded that 3D printing based workflow is accurate enough to be used for presurgical planning for complex adolescent spinal deformities. Image acquisition and post processing parameters, type of 3D printing technology plays key role in acquiring required accuracy for surgical applications.

Published
2023
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2. Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial

Author

Andrew Metcalfe, Helen Parsons, Nicholas Parsons, Jaclyn Brown, Josephine Fox, Elke Gemperlé Mannion, Aminul Haque, Charles Hutchinson, Rebecca Kearney, Iftekhar Khan, Tom Lawrence, James Mason, Nigel Stallard, Martin Underwood, Stephen Drew, Azra Arif, Susanne Arnold, Gev Bhabra, Sunayna Bora, Howard Bush, Jo Fox, Ceri Jones, Thomas Lawrence, Kerri McGowan, Chetan Modi, Bushra Rahman, Usama Rahman, Maria Ramirez, Marta Spocinska, Joanna Teuke, Varjithan Thayalan, Sumayyah Ul-Rahman, Aparna Viswanath, Iain Packham, Elizabeth Barnett, Rian Witham, Mark Crowther, Richard Murphy, Katherine Coates, Josephine Morley, Stephen Barnfield, Sukhdeep Gill, Alistair Jones, Ruth Halliday, Sarah Dunn, James Fagg, Peter Dacombe, Rajesh Nanda, Deborah Wilson, Lesley Boulton, Raymond Liow, Richard Jeavons, Andrea Meddes, Niel Kang, Leila Dehghani, Aileen Nacorda, Anuj Punnoose, Nicholas Ferran, Gbadebo Adewetan, Temi Adedoyin, Arun Pall, Matthew Sala, Tariq Zaman, Richard Hartley, Charif a-Sayyad, Luke Vamplew, Elizabeth Howe, Norbert Bokor, Steve Corbett, Robert Moverley, Elise Cox, Oliver Donaldson, Michael Jones, Diane Wood, Jess Perry, Alison Lewis, Linda Howard, Kate Beesley, Luke Harries, Ahmed Elmorsy, Katherine Wilcocks, Kate Shean, Sarah Diment, Helen Pidgeon, Victoria King, Soren Sjolin, Angharad Williams, Joanne Kellett, Lora Young, Michael Dunne, Tom Lockwood, Mark Curtis, Nashat Siddiqui, India Mckenley, Sarah Morrison, Charlotte Morrison, Tracey O'Brien, Isabel Bradley, Kenneth Lambatan, Cormac Kelly, Charlotte Perkins, Teresa Jones, Tessa Rowlands, Dawn Collins, Claire Nicholas, Claire Birch, Julie Lloyd -Evans, Pouya Akhbari, Jefin Jose Edakalathu, Campbell Hand, Andy Cole, Debbie Prince, Kerry Thorpe, Louise Rooke, Maria Baggot, Matt Morris, Dima Ivanova, David Baker, Tim Matthews, Jessica Falatoori, Heather Jarvis, Debbie Jones, Matthew Williams, Richard Evans, Huw Pullen, Gemma Hodkinson, Nicola Vannet, Alison Davey, Emma Poyser, Angela Hall, Hemang Mehta, Devi Prakash Tokola, Clare Connor, Caroline Jordan, Owain Ennis, Zohra Omar, Tracy Lewis, Angharad Lisa Owen, Andrew Morgan, Ravi Ponnada, Waheeb Al-Azzani, Carolyn Williams, Liam Knox, Harvinder Singh, Tracy Lee, Kathryn Robinson, Dileep Kumar, Alison Armstrong, Addie Majed, Mark Falworth, David Butt, Deborah Higgs, Will Rudge, Ben Hughes, Esther Hanison, Deirdre Brooking, Amit Patel, Andrew Symonds, Jenifer Gibson, Rodney Santiago, David Barlow, Joanne Lennon, Christopher Smith, Jane Hall, Emily Griffin, Rebecca Lear, William Thomas, David Rose, Janet Edkins, Helen Samuel, Hagen Jahnich, John Geoghegan, Ben Gooding, Siobhan Hudson, Jess Nightingale, Madhavan Papanna, Tom Briggs, Rebecca Pugh, Amy Neal, Lisa Warrem, Veronica Maxwell, Robert Chadwick, Thomas Jaki, Loretta Davies, Stephen Gwilym, Rod Taylor, Geoffrey Abel, John Graham, Christopher Littlewood, Angus Wallace, and Anthony Howard

Subjects
Male, Arthroscopy, Shoulder, Treatment Outcome, Shoulder Pain, Humans, Female, General Medicine, Muscle, Skeletal, RD, Rotator Cuff Injuries
Abstract

New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Published
2022
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