Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Stabilitetsstudien (STABILITY)

2. november 2026 oppdatert av: Spinal Simplicity LLC

Stabilitetsstudien: Funksjonelle bevegelsesutfall hos pasienter behandlet med en interspinous fusjonsenhet for degenerative tilstander i lumbalryggen

This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Up to 150 subjects will be enrolled and treated at up to 20 study sites. Qualified subjects will be enrolled and treated with the Minuteman G5 Device. Subjects will be seen at 1-, 3-, 6- and 12-months following study treatment.

Key outcome assessments will include gait and balance testing performed using BioMech Lab sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. Patient reported outcome measures will also be collected to evaluate pain, quality of life and satisfaction. During the primary assessment at 12-months post-treatment subject will be offered a computerized topography (CT) scan to evaluate spinal fusion.

After completion of the Month 12 visit all subjects will be asked to complete annual visits through 5 years, which include collection of PROMs, safety review, and can be completed in person or remote.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Georgia
      • Newnan, Georgia, Forente stater, 30265
        • Rekruttering
        • Vista Clinical Research
        • Hovedetterforsker:
          • Sandeep Vaid, MD
        • Ta kontakt med:
          • Debra Helton
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46250
        • Rekruttering
        • Comprehensive Pain & Spine Specialists
        • Hovedetterforsker:
          • Andrew Trobridge, MD
        • Ta kontakt med:
          • Esther Owusu
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Har ikke rekruttert ennå
        • University of Kansas Medical Center
        • Ta kontakt med:
          • Manuel Clark
        • Hovedetterforsker:
          • Usman Latif, MD, MBA
        • Underetterforsker:
          • Dawood Sayed, MD
    • Louisiana
      • Slidell, Louisiana, Forente stater, 70458
        • Rekruttering
        • Paradigm Health System
        • Ta kontakt med:
        • Hovedetterforsker:
          • Neilson Tran, MD
    • Minnesota
      • Edina, Minnesota, Forente stater, 55435
        • Rekruttering
        • Nura Precision Pain Management
        • Ta kontakt med:
          • Ken Farmer
        • Hovedetterforsker:
          • R. Scott Stayner, MD
    • Oregon
      • Eugene, Oregon, Forente stater, 97404
        • Rekruttering
        • Pacific Sports & Spine
        • Hovedetterforsker:
          • Gregory Moore, MD
        • Ta kontakt med:
          • Katie Fabian
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25301
        • Rekruttering
        • Spine & Nerve Center of the Virginias
        • Hovedetterforsker:
          • Timothy Deer, MD
        • Ta kontakt med:
          • Amy Young, RN-RC
        • Underetterforsker:
          • Christopher Kim, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

A subject must MEET ALL of the following inclusion criteria:

  1. Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication
  2. Be willing and capable of giving written consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided
  3. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
  4. Be 18 years of age or older at the time of enrollment
  5. Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
  6. Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
  7. Be willing and able to comply with study-related requirements, procedures and visits
  8. Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
  9. Must disclose any unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the Investigator. Including being involved in an injury claim under current litigation or has a pending or approved worker's compensation claim. Subjects will not be excluded due to secondary gain, but it should be disclosed at Enrollment.

Exclusion Criteria

A subject must NOT MEET ANY of the following exclusion criteria:

  1. Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.
  2. Patient physically unable to perform the Gait and/or Balance tests.
  3. Current systemic infection or local infection increasing the risk of surgery
  4. History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
  5. Grade II-V spondylolisthesis
  6. Significant scoliosis with Cobb angle >10 degrees
  7. Unremitting back pain in a spinal flexion position
  8. Active systemic disease that may affect the welfare of the subject in the opinion of the Investigator
  9. Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) as determined by the investigator.
  10. Vertebral osteoporosis or history of vertebral fracture
  11. Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, subject must be willing to use a reliable form of birth control through the 3-month visit.
  12. Malformation or dysplasia of spinous process
  13. Severe osteoporosis with T score <-2.5 SD

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Surgical Group

patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine
Enhet: Minuteman G5 Device

The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain (Overall, Back and Leg) using NRS/numeric rating scale
Tidsramme: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

Overall pain, as well as back pain when standing/walking and leg pain when standing will be assessed using a numeric rating scale (NRS). The NRS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
Oswestry Disability Index (ODI)
Tidsramme: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
PROMIS 29 2.0
Tidsramme: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

PROMIS-29 c2.0 is a set of standardized questions that measures 29 items across 7 domains of physical and mental health. PROMIS-29 profile assesses pain intensity using a single 0-10 numeric rating scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. And seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Each domain is scored on T-Score Scale ranging between 22.9- 81.6 with a mean of 50 and a standard deviation of 10.
Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
Assessment of Motion using BioMech Lab testing equipment
Tidsramme: Baseline and 1-, 3- and 12-months post implantation.

A Primary Objective of this study is to collect real-world functional outcomes assessment of motion following treatment with the market-released Spinal Simplicity Minuteman G5 Device using BioMech Lab equipment to record gait and balance. The BioMech Lab motion analytics system will assess gait and balance via sensors placed before physical testing.
Baseline and 1-, 3- and 12-months post implantation.
Zurich Classification Questionnaire (ZCQ)
Tidsramme: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.

The ZCQ Symptom Severity, Physical Function and Subject Satisfaction allows subjects to rate their symptoms, function or satisfaction on a scale based on their experience over the past week.

Symptom Severity domain evaluates the intensity of symptoms such as pain and numbness. It comprises seven items, each rated on a scale from 1 to 5. Overall symptom score ranges from 7-49; with higher scores indicating more severe symptoms.

Physical Function domain assesses the impact of symptoms on daily activities. It includes five items, scored on a 1 to 4 scale. Overall symptom score ranges from 5-20; where higher scores denote greater functional impairment.

Subject Satisfaction domain measures patient satisfaction with treatment outcomes. It consists of six items, each rated from 1 to 4, with higher scores reflecting greater dissatisfaction. Overall Satisfaction ranges from 6-24: where higher scores denote greater dissatisfaction.
Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan
Tidsramme: Collected at 12 months post implantation.

The secondary objective is to assess spinal fusion at 12 months post-operative using a Fusion Assessment Scale provided by Spinal Simplicity based on review of Lumbar CT Scan.
Collected at 12 months post implantation.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Spinal Simplicity LLC

Etterforskere

  • Studiestol: Tom Hedman, PhD, Spinal Simplicity

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. mai 2024

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

26. mars 2024

Først innsendt som oppfylte QC-kriteriene

3. april 2024

Først lagt ut (Faktiske)

9. april 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PDPROJ-4-TP-001-23

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Patients will be deidentified with unique study ID. Any study will be anonymized.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere