Long-term Reoperations After Lumbar Spinal Stenosis Surgery

NCT06407063 | Recruiting

• 1 other identifier: 2813
• Study Type: observational
• Target: 794
• Locations: 1 country
• Sites: 1

Brief Summary

Severe and persisting pain and disability due to a degenerative narrowing of the spinal canal, lumbar spinal stenosis, can be operated with a simple surgical decompression. Sometimes, there is also a slippage of vertebra, degenerative spondylolisthesis. In such cases, instrumental stabilization (e.g. screws and rods) has been recommended. Even though additional fusion is more complex and riskier, and evidence in high-quality Scandinavian studies shows that it is unnecessary, decompression plus fusion is still the treatment of choice in the USA and most European countries. This reluctance to change clinical practice is mainly due to concerns about long-term results, especially higher reoperation rates among patients operated with decompression only. This register-based non-inferiority study aims to assess long-term reoperations among those treated with and without additional fusion surgery.

Conditions

Degenerative Lumbar Spondylolisthesis

Keywords

Degenerative Spondylolisthesis; Treatment; Decompression alone; Instrumented fusion; Reoperations

Outcome Measures

Primary Outcomes (1)

• Estimated reoperations rate (n, %) at 10 years follow-up (Survival function (S(t), t=10 years) for first reoperation) by treatment group

  Survival function for a reoperation at 10 years. A new operation in the lumbosacral spine (excluding surgery for tumor and trauma) during follow up, occurring more than 90 days after index surgery is defined as reoperation.

  From date of index operation (2007-2015) until end of follow up August 31st 2023

Secondary Outcomes (3)

• Hazard ratio(s) and survival functions for reoperation and reoperations rates by treatment group.

  From date of index operation (2007-2015) until end of follow up August 31st 2023

• Rate of reoperations within 90 days after index surgery (n %) by treatment group.

  From date of index operation (2007-2015) until 90 days after index surgery

• Other complications (n %) by treatment group

  Reported at baseline and 3 months after the index operation

Study Arms (1)

Patients treated for Degenerative Spondylolisthesis

Patients operated for Degenerative Spondylolisthesis with Lumbar Spinal Stenosis

Procedure: Micro-decompression alone; Procedure: Decompression and instrumented fusion

Interventions

Micro-decompression alone PROCEDURE

In surgical treatment of Degenerative Spondylolisthesis patients are operated on with a midline-preserving decompression without fusion

Patients treated for Degenerative Spondylolisthesis

Decompression and instrumented fusion PROCEDURE

In surgical treatment of Degenerative Spondylolisthesis patients are operated on with a decompression followed by an instrumental fusion with or without an additional cage

Patients treated for Degenerative Spondylolisthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population is defined by the NORspine registry and contains all patients in the register in the priode September 19 2007 to Desember 21 2015 that fulfil the eligibility criteria. The NORspine register cases in a specialiced health care setting from the Norwegian providers of lumbar spine surgery.

You may qualify if:

• operated between September 2007 and December 2015 labeled in the registry with both 'Spinal stenosis' and 'Degenerative spondylolisthesis'
• operated on with decompression with or without an additional fusion

You may not qualify if:

• operated with an anterior approach
• had a former operation at index Level
• was labeled with a degenerative scoliosis
• was operated in more than 2 Levels
• was operated with non-instrumented fusion
• operated with a standard laminectomy with removing of the posterior midline structures or operated without magnifying devices was excluded from the micro-decompression group

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Royal Norwegian Ministry of Health: collaborator
• Haukeland University Hospital: collaborator

Study Sites (1)

University hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

Related Publications (6)

• Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.

  PMID: 2071615 BACKGROUND

• Bridwell KH, Sedgewick TA, O'Brien MF, Lenke LG, Baldus C. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. J Spinal Disord. 1993 Dec;6(6):461-72. doi: 10.1097/00002517-199306060-00001.

  PMID: 8130395 BACKGROUND

• Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.

  PMID: 27074066 BACKGROUND

• Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.

  PMID: 27074067 BACKGROUND

• Austevoll IM, Gjestad R, Solberg T, Storheim K, Brox JI, Hermansen E, Rekeland F, Indrekvam K, Hellum C. Comparative Effectiveness of Microdecompression Alone vs Decompression Plus Instrumented Fusion in Lumbar Degenerative Spondylolisthesis. JAMA Netw Open. 2020 Sep 1;3(9):e2015015. doi: 10.1001/jamanetworkopen.2020.15015.

  PMID: 32910195 BACKGROUND

• Austevoll IM, Hermansen E, Fagerland MW, Storheim K, Brox JI, Solberg T, Rekeland F, Franssen E, Weber C, Brisby H, Grundnes O, Algaard KRH, Boker T, Banitalebi H, Indrekvam K, Hellum C; NORDSTEN-DS Investigators. Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis. N Engl J Med. 2021 Aug 5;385(6):526-538. doi: 10.1056/NEJMoa2100990.

  PMID: 34347953 BACKGROUND

MeSH Terms

Interventions

Decompression

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena

Study Officials

• Tore Solberg, Prof

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eirik Mikkelsen, MD

CONTACT

eirik.mikkelsen@unn.no

Tore Solberg, Prof

CONTACT

+47 91364531; Tore.Solberg@unn.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: September 19, 2007
• Primary Completion: December 11, 2024
• Study Completion: April 30, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)