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NCT03072927ClinicalTrials.gov

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

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En resumen

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of…

Observacional8000 participantes buscados2388 centros1 país

Categorías

Musculoesquelético100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2017-03-07; recorded start 2017-03-10
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Whether the study is blinded is not stated in the registry recordNo masking information is recorded
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Stryker Instruments)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Masking not stated in the record

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 2343 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEGA

A very large study: 8,000 participants (target), run at 2,388 sites.

How this score is built
  • Enrolment37/40

    8,000 participants (target)

  • Site count25/25

    2,343 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 118 months

  • Sponsor scale1/10

    Stryker Instruments has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

Afecciones

  • Lumbar Spinal Stenosis

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo
Método de muestreoPROBABILITY_SAMPLE

Población del estudio

Study participants will include Medicare beneficiaries for whom claims have been submitted to the Medicare Claims database and who have been enrolled in Medicare fee-for-service or Medicare Advantage for one year prior to their index procedure and two years post index procedure.

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Medicare beneficiaries receiving MILD or interspinous process decompression * Diagnosis of LSS with NC Exclusion Criteria: * Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioObservacional
FaseNo indicado en el registro
AsignaciónNo indicado en el registro
Modelo de intervenciónNo indicado en el registro
Propósito principalNo indicado en el registro
EnmascaramientoNo indicado en el registro
Inscripción8000 participantes buscados

Patrocinador y colaboradores

  • Stryker Instruments Patrocinador

Grupos e intervenciones

  • MILD

    All Medicare patients treated with MILD as reported via CPT® Code 0275T or successor codes (62330/62331).

  • Interspinous Process Decompression

    All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.

Intervenciones

  • Dispositivo Interspinous Process Decompression

    Interspinous Process Decompression

  • Dispositivo MILD

    MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.

Variables de resultado

  1. Variable de resultado principal

    Rate of participants with harms associated with the index procedure

    Rate of participants with harms associated with the index procedure including, but not limited to, revisions, displacement, mechanical complications, and death. Complications will be counted if they are recorded during the index hospitalization, or any rehospitalization within 30 days of discharge.

    Plazo 24 months

  2. Variable de resultado principal

    Rate of surgical, minimally invasive intervention.

    Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.

    Plazo 24 months

Fechas

Fecha de inicio10 de marzo de 2017 (real)
Finalización principal1 de diciembre de 2026 (estimada)
Finalización1 de diciembre de 2026 (estimada)
Primera publicación7 de marzo de 2017 (real)
Última actualización4 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezenero de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

2383 centros están en reclutamiento

United States

CentroCiudadEstado o regiónEstado
Abilene Spine and Joint Surgery CenterAbileneTexasEn reclutamiento
Hendrick Med Ctr SouthAbileneTexasEn reclutamiento
Abilene Ctr For Ortho and MultiAbileneTexasEn reclutamiento
Abington Memorial HospitalAbingtonPennsylvaniaEn reclutamiento
Center for Spine Interventions ASC, LLC (ASC3)AcworthGeorgiaEn reclutamiento
Apex Surgery CenterAdaOklahomaEn reclutamiento
Ambulatory Surgical Institute of DallasAddisonTexasEn reclutamiento
Star Valley Med CtrAftonWyomingEn reclutamiento
Vidant Roanoke Chowan Hospital- Pain ManagementAhoskieNorth CarolinaEn reclutamiento
Aiken Regional Medical CenterAikenSouth CarolinaEn reclutamiento
Parkwest Surgical CtrAkronOhioEn reclutamiento
Waverly Surgery CenterAlbanyOregonEn reclutamiento
Everett Road Surgery CenterAlbanyNew YorkEn reclutamiento
OrthoNYAlbanyNew YorkEn reclutamiento
VA Medical CenterAlbuquerqueNew MexicoEn reclutamiento
University of New Mexico HospitalAlbuquerqueNew MexicoEn reclutamiento
Outpatient Surg and Imaging SvcsAlbuquerqueNew MexicoEn reclutamiento
Modern Pain & Spine PCAlbuquerqueNew MexicoEn reclutamiento
Center for Pain Management Ambulatory Surgery, LLCAlexandriaMinnesotaEn reclutamiento
Pacific Ambulatory Surgery CenterAlhambraCaliforniaEn reclutamiento
Western PA Surg Ctr Beaver CountyAliquippaPennsylvaniaEn reclutamiento
Northaven Surg CtrAllenTexasEn reclutamiento
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaEn reclutamiento
Surgery Center of AllentownAllentownPennsylvaniaEn reclutamiento
Carepath Injury Ctr of PennsylvaniaAllentownPennsylvaniaEn reclutamiento
Cedar Crest Surg CtrAllentownPennsylvaniaEn reclutamiento
Aultman Alliance Community HospitalAllianceOhioEn reclutamiento
Bacon County HospitalAlmaGeorgiaEn reclutamiento
Pain Physicians of AtlantaAlpharettaGeorgiaEn reclutamiento
Advanced AscAltamonte SpringsFloridaEn reclutamiento
Alton Memorial HospitalAltonIllinoisEn reclutamiento
OSF Saint Anthony Medical CenterAltonIllinoisEn reclutamiento
Allegheny Surgery CenterAltoonaPennsylvaniaEn reclutamiento
Oakleaf Surgl HospAltoonaWisconsinEn reclutamiento
Ctr For the Surgl ArtsAltoonaPennsylvaniaEn reclutamiento
Acute & Chronic Pain and Spine Center Ambulatory Surgery CenterAmarilloTexasEn reclutamiento
Surgery Center of AmarilloAmarilloTexasEn reclutamiento
Ames Surgery CenterAmesIowaEn reclutamiento
Amherst Surgery CenterAmherstNew YorkEn reclutamiento
Island Health HospitalAnacortesWashingtonEn reclutamiento
Unicare Surgery CenterAnaheimCaliforniaEn reclutamiento
AA Spine & Pain ClinicAnchorageAlaskaEn reclutamiento
Memorial Hermann Surgery Center BrazoriaAngletonTexasEn reclutamiento
Ann Arbor Surgl CtrAnn ArborMichiganEn reclutamiento
East Ann Arbor Amb Surg and MedAnn ArborMichiganEn reclutamiento
Univ of Michigan Univ HospAnn ArborMichiganEn reclutamiento
Medstar Surg Ctr At AnnapolisAnnapolisMarylandEn reclutamiento
Riva Road Surgery CenterAnnapolisMarylandEn reclutamiento
Clearway Pain SolutionsAnnapolisMarylandEn reclutamiento
AdventHealth OrlandoApopkaFloridaEn reclutamiento

En el registro figuran 2338 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 4 de septiembre de 2026

    Centro añadido

    18 sites added (2388 total)

    23702388

  2. 1 de septiembre de 2026

    Centro añadido

    1 site added (2370 total)

    23692370

  3. 18 de agosto de 2026

    Centro añadido

    1 site added (2369 total)

    23682369

  4. 10 de agosto de 2026

    Centro añadido

    25 sites added (2368 total)

    23432368

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT03072927