Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
05 08 2021
05 08 2021
Historique:
entrez:
4
8
2021
pubmed:
5
8
2021
medline:
21
8
2021
Statut:
ppublish
Résumé
In patients with lumbar spinal stenosis and degenerative spondylolisthesis, it is uncertain whether decompression surgery alone is noninferior to decompression with instrumented fusion. We conducted an open-label, multicenter, noninferiority trial involving patients with symptomatic lumbar stenosis that had not responded to conservative management and who had single-level spondylolisthesis of 3 mm or more. Patients were randomly assigned in a 1:1 ratio to undergo decompression surgery (decompression-alone group) or decompression surgery with instrumented fusion (fusion group). The primary outcome was a reduction of at least 30% in the score on the Oswestry Disability Index (ODI; range, 0 to 100, with higher scores indicating more impairment) during the 2 years after surgery, with a noninferiority margin of -15 percentage points. Secondary outcomes included the mean change in the ODI score as well as scores on the Zurich Claudication Questionnaire, leg and back pain, the duration of surgery and length of hospital stay, and reoperation within 2 years. The mean age of patients was approximately 66 years. Approximately 75% of the patients had leg pain for more than a year, and more than 80% had back pain for more than a year. The mean change from baseline to 2 years in the ODI score was -20.6 in the decompression-alone group and -21.3 in the fusion group (mean difference, 0.7; 95% confidence interval [CI], -2.8 to 4.3). In the modified intention-to-treat analysis, 95 of 133 patients (71.4%) in the decompression-alone group and 94 of 129 patients (72.9%) in the fusion group had a reduction of at least 30% in the ODI score (difference, -1.4 percentage points; 95% CI, -12.2 to 9.4), showing the noninferiority of decompression alone. In the per-protocol analysis, 80 of 106 patients (75.5%) and 83 of 110 patients (75.5%), respectively, had a reduction of at least 30% in the ODI score (difference, 0.0 percentage points; 95% CI, -11.4 to 11.4), showing noninferiority. The results for the secondary outcomes were generally in the same direction as those for the primary outcome. Successful fusion was achieved with certainty in 86 of 100 patients (86.0%) who had imaging available at 2 years. Reoperation was performed in 15 of 120 patients (12.5%) in the decompression-alone group and in 11 of 121 patients (9.1%) in the fusion group. In this trial involving patients who underwent surgery for degenerative lumbar spondylolisthesis, most of whom had symptoms for more than a year, decompression alone was noninferior to decompression with instrumented fusion over a period of 2 years. Reoperation occurred somewhat more often in the decompression-alone group than in the fusion group. (NORDSTEN-DS ClinicalTrials.gov number, NCT02051374.).
Sections du résumé
BACKGROUND
In patients with lumbar spinal stenosis and degenerative spondylolisthesis, it is uncertain whether decompression surgery alone is noninferior to decompression with instrumented fusion.
METHODS
We conducted an open-label, multicenter, noninferiority trial involving patients with symptomatic lumbar stenosis that had not responded to conservative management and who had single-level spondylolisthesis of 3 mm or more. Patients were randomly assigned in a 1:1 ratio to undergo decompression surgery (decompression-alone group) or decompression surgery with instrumented fusion (fusion group). The primary outcome was a reduction of at least 30% in the score on the Oswestry Disability Index (ODI; range, 0 to 100, with higher scores indicating more impairment) during the 2 years after surgery, with a noninferiority margin of -15 percentage points. Secondary outcomes included the mean change in the ODI score as well as scores on the Zurich Claudication Questionnaire, leg and back pain, the duration of surgery and length of hospital stay, and reoperation within 2 years.
RESULTS
The mean age of patients was approximately 66 years. Approximately 75% of the patients had leg pain for more than a year, and more than 80% had back pain for more than a year. The mean change from baseline to 2 years in the ODI score was -20.6 in the decompression-alone group and -21.3 in the fusion group (mean difference, 0.7; 95% confidence interval [CI], -2.8 to 4.3). In the modified intention-to-treat analysis, 95 of 133 patients (71.4%) in the decompression-alone group and 94 of 129 patients (72.9%) in the fusion group had a reduction of at least 30% in the ODI score (difference, -1.4 percentage points; 95% CI, -12.2 to 9.4), showing the noninferiority of decompression alone. In the per-protocol analysis, 80 of 106 patients (75.5%) and 83 of 110 patients (75.5%), respectively, had a reduction of at least 30% in the ODI score (difference, 0.0 percentage points; 95% CI, -11.4 to 11.4), showing noninferiority. The results for the secondary outcomes were generally in the same direction as those for the primary outcome. Successful fusion was achieved with certainty in 86 of 100 patients (86.0%) who had imaging available at 2 years. Reoperation was performed in 15 of 120 patients (12.5%) in the decompression-alone group and in 11 of 121 patients (9.1%) in the fusion group.
CONCLUSIONS
In this trial involving patients who underwent surgery for degenerative lumbar spondylolisthesis, most of whom had symptoms for more than a year, decompression alone was noninferior to decompression with instrumented fusion over a period of 2 years. Reoperation occurred somewhat more often in the decompression-alone group than in the fusion group. (NORDSTEN-DS ClinicalTrials.gov number, NCT02051374.).
Identifiants
pubmed: 34347953
doi: 10.1056/NEJMoa2100990
doi:
Banques de données
ClinicalTrials.gov
['NCT02051374']
Types de publication
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
526-538Subventions
Organisme : Helse Vest
ID : Helse Vest 911884.
Investigateurs
Christian Hellum
(C)
Jørn Aaen
(J)
Masoud Anwar
(M)
Ivar Magne Austevoll
(IM)
Hasan Banitalebi
(H)
Helena Brisby
(H)
Jens Ivar Brox
(JI)
Eric Franssen
(E)
Oliver Grundnes
(O)
Erland Hermansen
(E)
Kari Indrekvam
(K)
Inger Ljostad
(I)
Frode Rekeland
(F)
Tore Solberg
(T)
Kjersti Storheim
(K)
Clemens Weber
(C)
Anniken Remseth
(A)
Bodil Røyset
(B)
Ivar M Austevoll
(IM)
Ingrid Fjellheim Bånerud
(IF)
Eira Kathleen Ebbs
(EK)
Maren Hjelle Guddal
(MH)
Marie Skovli Pettersen
(MS)
Ørjan Nesse Vigdal
(ØN)
Katarina Mølsæter
(K)
Therese Gundersen
(T)
Trine Myrvold
(T)
Ole Kristian Alhaug
(OK)
Sverre Mjønes
(S)
Abdullah Cetinkaia
(A)
Filip Dolatowski
(F)
Christina Handeland
(C)
Arild Ulvestad
(A)
Turid Rognsvåg
(T)
Janne Haugland
(J)
Eva Saltskår Jentoft
(ES)
Truls Rokne Hanestad
(T)
Eric Kgomotso
(E)
Magnus Valland
(M)
Ørjan Stensletten
(Ø)
Mohammed Ahmed
(M)
Andreas Seip
(A)
Rune Birketvedt
(R)
Samer Habiba
(S)
Kristine Helland
(K)
Linda Sæterdal
(L)
Maria Rieber-Mohn
(M)
Truls Hanestad
(T)
Sylvi Ann Sagstad
(SA)
Per Torgeir Nilsen
(PT)
Arnfinn Pedersen
(A)
Hege Westgård
(H)
Anders Tønsager
(A)
Håvard Furunes
(H)
Espen Mørk
(E)
Inger Opheim
(I)
Hege Bergum Nilsen
(HB)
Øyvind Sletten
(Ø)
Aina Strøm
(A)
Eirik Østvold Melandsø
(EØ)
Maria Van My Nguyen Giebers
(M)
Vinjar Hansen
(V)
Greger Lønne
(G)
Roar Rønning
(R)
Gisle Szacinski
(G)
Vidar Punsvik
(V)
Anita Karin Vassbakk
(AK)
Alf Hellevik
(A)
Espen Sjåberg
(E)
Ellen Aksnes
(E)
Roger Trana
(R)
Ole Rasmus Robak
(OR)
Morten Karlsen
(M)
Jon Magne Hoseth
(JM)
Ali Al-Ashtari
(A)
Geir Jomaas
(G)
Marte Magnusson
(M)
Mads Rolfsen
(M)
Trine Strøm
(T)
Hege C Trygg
(HC)
Knut Harboe
(K)
Elisabeth Rettedal
(E)
Kirstine Eikenes
(K)
Gabriel Lande
(G)
Hilde Olsen
(H)
Tomm Müller
(T)
Camilla Brattbakk
(C)
Hege Andresen
(H)
Øystein Nygaard
(Ø)
Pål Amesen
(P)
Yngve Sporstøl
(Y)
Ted P Lundgren
(TP)
Anne-Charlotte Fosse Haug
(AC)
Elisabeth Lilleholdt Muller
(EL)
Odd Arild Ågedal
(OA)
Kjartan Krogedal
(K)
Knut Jørgen Haug
(KJ)
Ingrid Edbo
(I)
Rune Hennig
(R)
Andreas Sørlie
(A)
Jørgen Isaksen
(J)
Jens Munch-Ellingsen
(J)
Kristine Evanger
(K)
Caroline W Thórisdóttir
(CW)
Vibeke Grønaas
(V)
Marilyn Botn
(M)
Silje M Nilssen
(SM)
Lasse Andreassen
(L)
Sunniva Andreassen
(S)
Sara Kristin Sørend
(SK)
Vidar Opland
(V)
Merete Finjarn
(M)
Ellen Langslet
(E)
Wender Figved
(W)
Lars Forberg
(L)
Erik Øygarden
(E)
Lauritz Dahl
(L)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
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