Abstract
OBJECTIVE: To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation.
DESIGN: Multicentre randomised controlled trial with non-inferiority design.
SETTING: Four hospitals in the Netherlands.
PARTICIPANTS: 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial.
INTERVENTIONS: PTED (n=179) compared with open microdiscectomy (n=309).
MAIN OUTCOME MEASURES: The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses.
RESULTS: At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis.
CONCLUSIONS: PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica.
TRIAL REGISTRATION: NCT02602093ClinicalTrials.gov NCT02602093.
Original language | English |
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Article number | e065846 |
Pages (from-to) | e065846 |
Journal | BMJ (Clinical research ed.) |
Volume | 376 |
DOIs | |
Publication status | Published - 21 Feb 2022 |
Bibliographical note
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Funding
We gratefully acknowledge the support of the Dutch Health Insurance Board; ZonMw, the Netherlands Organisation for Health Research and Development; the participating patients; the patients’ organisation de Wervelkolom (nvvr); Pieter J Schutte (Alrijne Hospital) and Arnold Vreeling (Rijnstate Hospital) as study surgeons; and the research nurses Esther Willemsen, Steffi van Beek, Chantal Ritskes, Monique Stuit (Park MC), Paula van Limpt (Elisabeth-TweeSteden Hospital), Moniek Vroemen, Annemiek Hol (Rijnstate Hospital), and Marjon Nuijten (LUMC, Alrijne Hospital). Contributors: PG, SR, MdB, MvT, JvS, WP, and BH conceived the study, designed the trial, and obtained grant funding. PG and AS initiated the trial under the supervision of SR and BH. PG, SR, and BH managed the trial. PG acquired the data with the help of the research nurses. AS was also partially involved in acquiring the data. BH trained the learning curve surgeons. BH, JvS, and PD were three of the trial surgeons. PG did the statistical analysis under the supervision of MdB. PG wrote the first draft of the manuscript. All authors were responsible for the interpretation of the data and for reviewing and approving the final submitted manuscript. BH is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Funding: This study was funded by ZonMw, the Netherlands Organisation for Health Research and Development (project number 837004013). ZonMw did not participate in the study design; in the conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, and approval of the manuscript.
Funders | Funder number |
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Alrijne Hospital | 837004013 |
Dutch Health Insurance Board | |
Marjon Nuijten | |
ZonMw | |
Leids Universitair Medisch Centrum |
Keywords
- Adolescent
- Adult
- Aged
- Diskectomy/methods
- Endoscopy
- Female
- Humans
- Leg
- Lumbar Vertebrae
- Male
- Microsurgery/methods
- Middle Aged
- Pain/diagnosis
- Pain Measurement/statistics & numerical data
- Quality of Life
- Sciatica/complications
- Self Report/statistics & numerical data
- Treatment Outcome
- Young Adult