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Rejestr SLIP II: Laminektomia rdzeniowa a zespolenie śruby przeznasadowej za pomocą przyrządów (SLIPII)

6 listopada 2026 zaktualizowane przez: Lahey Clinic

Rejestr SLIP II: Laminektomia kręgosłupa do laminektomii z zespoleniem instrumentalnym śruby przeznasadowej w przypadku zwężenia odcinka lędźwiowego z kręgozmykiem I stopnia

The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires.

In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. >80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.'

In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation.

This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

Aim: To conduct a randomized control trial comparing patient outcomes and satisfaction with or without expert panel review before making a final decision about surgery for grade I degenerative lumbar spondylolisthesis. A prospective, multi-center registry aimed at addressing important issues pertaining to outcomes from treatment for degenerative spondylolisthesis and spinal stenosis will also be generated.

Background: Surgery may be offered to patients with symptomatic lumbar stenosis with degenerative lumbar spondylolisthesis who fail nonoperative treatment measures including physical therapy and epidural steroid injections. For patients with lumbar stenosis without spondylolisthesis, a decompression alone is typical, while those patients who do have degenerative spondylolisthesis and who also have significant mechanical back pain may be offered lumbar decompression with or without fusion. These guidelines were written based upon the SPORT study, which provided the highest quality of evidence available at the time. Additional studies have show that costly interventions such as lumbar fusion may ultimately be cost-effective if they provide durable clinical benefit. Two recent publications in The New England Journal of Medicine present new evidence with conflicting results on superficial review. The Spinal Laminectomy versus Instrumented Pedicle Screw (SLIP) trial provides level I evidence for the efficacy of fusion to improve clinical outcomes and lower reoperation rates compared to a standard laminectomy and medial facetectomy over a four year time frame in patients with neurogenic claudication associated with stable single level spondylolisthesis. Conversely, the Swedish study provides level II evidence that the addition of a variety of fusion techniques does not have significant benefit in the first two years following operation compared to a variety of decompression techniques in a heterogeneous population of patients with stenosis associated with spondylolisthesis. The patient populations treated, surgical techniques used, and outcome measures assessed differed between the two studies and when taken together, underline the need to new comparative effectiveness data for patients with this problem.

Additionally, one key challenge surgeons face is whether or not to recommend a spinal fusion. Spinal fusion is expensive, assoicated with greater costs and complications, but it appears to be necessary in at least 30% of patients.3 Preliminary data suggests that when when greater than 80% of an expert panel votes for one treatment opition, either a fusion or decompression alone, and when a patient's actual treatment aligns with the expert panel recommention, the patient-reported outcomes are greater than when the surgical approach is not aligned with the expert panel.10 This data highlights an interest in developing articifical intelligence (AI) that may be able to aid in both identification and predictive tasks. Any progress in this realm would be enormously powerful from a clinical standpoint and would likely result in more efficient use of surgical appraoches and in turn, healthcare spending.

All images that are captured in the registry will be used to train convolutional neural networks (CNN). These are mathematical operations which extract patterns from image data and generalize it across many images fed into the dataset. They primarily use calculations to extract patterns which are stored as a model which will be a collection of numbers. The images stored in this registry will be used to develop algorithms to assess cases in which an expert panel is more likely to suggest one treatment over the other as well as develop an algorithm that would prospectively classify patients as either 'stable' or 'unstable.'

Plan: Before making a decision regarding which specific operation should be performed in each case, each patient will be randomized to receive an expert panel review or to not receive an expert panel review. For patients who receive an expert panel review, the patients' de-identified lumbar MRI (sagittal and key axial images), 36-inch standing plain radiographs (if available), and flexion and extension radiographs will be uploaded into a web-based platform and reviewed with plans to share the reviews with patients and their treating physicians in real time. For patients who are randomized to no expert panel review, they will discuss with their surgeon the best surgical option for them and proceed as they would in standard of care. Patients with symptomatic lumbar spinal stenosis and single level degenerative grade I spondylolisthesis will be treated either with decompression or decompression with fusion. Symptomatic spinal stenosis will be defined as radicular and/or back pain either induced by or aggravated by activity and relieved by rest in a patient with either moderately severe or severe lumbar spinal stenosis. Patient-reported outcomes will be captured at baseline, at 3 and 6 months, and annually out to five years.

The imaging data will be used to create artificial intelligence (AI) algorithms that will help assess when an expert panel is more likely to suggest one treatment over the other as well as develop an algorithm that would prospectively classify patients as either 'stable' or 'unstable.' Ultimately long term follow-up will help confirm whether a case was correctly assessed as stable or unstable. A patient would be confirmed as unstable, if they underwent decompression alone and then required a re-operation to stabilize the spine at the level of spondylolisthesis within 5 years of the initial operation. In a similar way, a patient would be confirmed as stable, if no re-operation were necessary over the 5-year study follow-up period.

Select sites will participate in an assessment of the utilization of step count as an outcome. Average step count will be captured pre-operatively as well as at 3- and 6-months and annually out to 5 years. The mean step count at each time point will be compared to the mean change scores for ODI and EQ-5D. Additionally, average step counts overtime will be analyzed for those patients who undergo a re-operation.

Interim Analysis: An interim analysis is planned when 150 patients have reached eligibility at 6 month follow-up. Patients' change from baseline patient-reported outcome questionnaires will be assessed.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

662

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5T 2S8
        • University Health Network - Toronto Western Hospital
  • Stany Zjednoczone
    • Arizona
      • Scottsdale, Arizona, Stany Zjednoczone, 85251
        • Barrow Brain and Spine
    • California
      • San Francisco, California, Stany Zjednoczone, 94143
        • University of California, San Fransisco
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33125
        • University of Miami
    • Illinois
      • Urbana, Illinois, Stany Zjednoczone, 61801
        • Carle Neurosciences Institute
    • Indiana
      • Carmel, Indiana, Stany Zjednoczone, 46032
        • Goodman Campbell Brain & Spine
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40202
        • Norton Leatherman Spine Center
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, Stany Zjednoczone, 01803
        • Lahey Hospital & Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455
        • University of Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55902
        • Mayo Clinic
    • New York
      • New York, New York, Stany Zjednoczone, 10021
        • Hospital for Special Surgery
      • New York, New York, Stany Zjednoczone, 10027
        • Columbia University
    • Ohio
      • Cleveland, Ohio, Stany Zjednoczone, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • University of Pittsburgh
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84132
        • University of Utah Hospital
    • Wisconsin
      • Madison, Wisconsin, Stany Zjednoczone, 53792
        • University of Wisconsin

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Symptomatic lumbar spinal stenosis: defined as radicular and/or back pain either induced or aggravated by activity and relieved by rest.
  • Single-level grade I degenerative spondylolisthesis (3-14mm)

Exclusion Criteria:

  • Serious medical illness (ASA Class IV or higher)
  • Spondylolysis
  • Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Expert Panel Review

For patients who are randomized to receive an expert panel review, de-identified lumbar MRI (sagittal and key axial images), 36-inch standing plain radiographs (if available), and flexion and extension radiographs will be uploaded into a web-based platform and reviewed. These will be submitted for an Expert Panel Review.

Images will be reviewed through a Spine Expert's Network, consisting of physicians involved in this study who will each offer their opinion as to which of two surgical treatment groups (decompression alone or decompression with fusion) they would choose for the patient. The results of this review will be discussed between the patient and the patient's physician. Together, they will determine the best surgical approach.
Inny: Expert Panel Review

There is some preliminary evidence suggesting that having a group of spinal experts review x-rays prior to treatment might provide useful information to the patient and the patients' treating physician when trying to make a decision about what type of surgery to perform.
Brak interwencji: No Expert Panel Review

For patients not receiving the expert panel review, they will discuss with their surgeon the best surgical option and proceed as they would in standard of care.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
EuroQol-5 Dimensions (EQ-5D)
Ramy czasowe: 1 year, 2 years, 3 years, 4 years, 5 years

Quality of life will be assessed through EuroQol 5 Dimensions (EQ-5D) at all time points. Analysis will focus on mean change score as well as the percentage of patients who fail to improve EQ-5D score at each time point. Patients randomized to expert panel review will be compared to those without expert panel review.
1 year, 2 years, 3 years, 4 years, 5 years
NASS patient satisfaction scale
Ramy czasowe: 1 year, 2 years, 3 years, 4 years, 5 years

The percentage of patients who achieve NASS patient satisfaction score of 1 or 2 will be compared at each time point between those patients who were randomized to an expert panel review or not.
1 year, 2 years, 3 years, 4 years, 5 years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Oswestry Disability Index (ODI)
Ramy czasowe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

To determine at 1 and 2 years if an expert panel review of individual cases is associated with a greater percentage of patients who improve by more than 10 points. In addition, we will compare mean change in ODI score among patients randomized to expert panel review to those randomized to receive no review.
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Oswestry Disability Index (ODI)
Ramy czasowe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

To compare mean change in ODI score between patients treated with laminectomy alone versus laminectomy with instrumented lumbar fusion
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
EuroQol-5 Dimensions (EQ-5D)
Ramy czasowe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Quality of life will be assessed through EuroQol 5 Dimensions (EQ-5D) at all time points. The three-level scale denotes no problems, some problems, or extreme problems, across the five domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A visual analog scale is also used to evaluate overall health state. Comparisons among groups will compare difference in the change scores.
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Cost Data -- Hospital Claims & Health Resource Utilization
Ramy czasowe: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Costs will also be compared between groups during the duration of the study.
3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Complications
Ramy czasowe: 1 month

Complications at time of surgery to 30 days post-operative will be collected.
1 month
Return to Work
Ramy czasowe: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Working status will be asked at all time points to capture productivity.
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Flexion-Extension Radiographs
Ramy czasowe: Baseline, 1 year, 2 years

To determine stability after surgery as well as fusion.
Baseline, 1 year, 2 years
36-inch Standing Plain Radiographs
Ramy czasowe: Baseline, 1 year

To assess spine alignment.
Baseline, 1 year

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Lahey Clinic

Śledczy

  • Główny śledczy: Zoher Ghogawala, MD, Lahey Hospital & Medical Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 października 2017

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

12 czerwca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 czerwca 2018

Pierwszy wysłany (Rzeczywisty)

27 czerwca 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2017-047

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Deidentified data would be shared with other researchers after primary analysis has been published.

Ramy czasowe udostępniania IPD

After primary analysis has been published for up to 5 years.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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