Long-term Reoperations After Lumbar Spinal Stenosis Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Micro-decompression alone
Procedure/SurgeryIn surgical treatment of Degenerative Spondylolisthesis patients are operated on with a midline-preserving decompression without fusion
Decompression and instrumented fusion
Procedure/SurgeryIn surgical treatment of Degenerative Spondylolisthesis patients are operated on with a decompression followed by an instrumental fusion with or without an additional cage
Treatment groups
794 Participants
are divided into 1 treatment groupGroup A: Patients treated for Degenerative Spondylolisthesis2 interventions
Trial outcomes
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.
Time frame
From date of index operation (2007-2015) until end of follow up August 31st 2023Secondary outcomes
1
Hazard ratio(s) and survival functions for reoperation and reoperations rates by treatment group.
Hazard ratio(s) and survival functions for reoperation and reoperations rates, reported at 2, 5 and 10 years follow-up. 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.
Time frame
From date of index operation (2007-2015) until end of follow up August 31st 20232
Rate of reoperations within 90 days after index surgery (n %) by treatment group.
This is reported separately since early reoperations (within 90 days) are categorized as complications in the NORspine (n %)
Time frame
From date of index operation (2007-2015) until 90 days after index surgery3
Other complications (n %) by treatment group
Complications (n %) related to index operation reported in NORspine. Surgeon and patient reported. e.g dural tear, postoperative haematoma, surgical site infection, thromboembolism (DVT, LE), pneumonia
Time frame
Reported at baseline and 3 months after the index operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of North Norway
Lead sponsor
The Royal Norwegian Ministry of Health
Collaborator
Haukeland University Hospital
Collaborator
Source ClinicalTrials.gov