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NCT03072927ClinicalTrials.gov

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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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…

Osservazionale8000 partecipanti ricercati2388 centri1 paese

Categorie

Apparato muscoloscheletrico100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Lumbar Spinal Stenosis

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo
Metodo di campionamentoPROBABILITY_SAMPLE

Popolazione dello studio

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.

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioOsservazionale
FaseNon indicato nella scheda del registro
AssegnazioneNon indicato nella scheda del registro
Modello di interventoNon indicato nella scheda del registro
Finalità principaleNon indicato nella scheda del registro
MascheramentoNon indicato nella scheda del registro
Arruolamento8000 partecipanti ricercati

Sponsor e collaboratori

  • Stryker Instruments Sponsor

Bracci e interventi

  • 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.

Interventi

  • 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.

Esiti misurati

  1. Esito primario

    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.

    Orizzonte temporale 24 months

  2. Esito primario

    Rate of surgical, minimally invasive intervention.

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

    Orizzonte temporale 24 months

Date

Data di inizio10 marzo 2017 (effettiva)
Conclusione primaria1 dicembre 2026 (stimata)
Conclusione1 dicembre 2026 (stimata)
Prima pubblicazione7 marzo 2017 (effettiva)
Ultimo aggiornamento4 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltagennaio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

2383 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
Abilene Spine and Joint Surgery CenterAbileneTexasIn reclutamento
Hendrick Med Ctr SouthAbileneTexasIn reclutamento
Abilene Ctr For Ortho and MultiAbileneTexasIn reclutamento
Abington Memorial HospitalAbingtonPennsylvaniaIn reclutamento
Center for Spine Interventions ASC, LLC (ASC3)AcworthGeorgiaIn reclutamento
Apex Surgery CenterAdaOklahomaIn reclutamento
Ambulatory Surgical Institute of DallasAddisonTexasIn reclutamento
Star Valley Med CtrAftonWyomingIn reclutamento
Vidant Roanoke Chowan Hospital- Pain ManagementAhoskieNorth CarolinaIn reclutamento
Aiken Regional Medical CenterAikenSouth CarolinaIn reclutamento
Parkwest Surgical CtrAkronOhioIn reclutamento
Waverly Surgery CenterAlbanyOregonIn reclutamento
Everett Road Surgery CenterAlbanyNew YorkIn reclutamento
OrthoNYAlbanyNew YorkIn reclutamento
VA Medical CenterAlbuquerqueNew MexicoIn reclutamento
University of New Mexico HospitalAlbuquerqueNew MexicoIn reclutamento
Outpatient Surg and Imaging SvcsAlbuquerqueNew MexicoIn reclutamento
Modern Pain & Spine PCAlbuquerqueNew MexicoIn reclutamento
Center for Pain Management Ambulatory Surgery, LLCAlexandriaMinnesotaIn reclutamento
Pacific Ambulatory Surgery CenterAlhambraCaliforniaIn reclutamento
Western PA Surg Ctr Beaver CountyAliquippaPennsylvaniaIn reclutamento
Northaven Surg CtrAllenTexasIn reclutamento
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaIn reclutamento
Surgery Center of AllentownAllentownPennsylvaniaIn reclutamento
Carepath Injury Ctr of PennsylvaniaAllentownPennsylvaniaIn reclutamento
Cedar Crest Surg CtrAllentownPennsylvaniaIn reclutamento
Aultman Alliance Community HospitalAllianceOhioIn reclutamento
Bacon County HospitalAlmaGeorgiaIn reclutamento
Pain Physicians of AtlantaAlpharettaGeorgiaIn reclutamento
Advanced AscAltamonte SpringsFloridaIn reclutamento
Alton Memorial HospitalAltonIllinoisIn reclutamento
OSF Saint Anthony Medical CenterAltonIllinoisIn reclutamento
Allegheny Surgery CenterAltoonaPennsylvaniaIn reclutamento
Oakleaf Surgl HospAltoonaWisconsinIn reclutamento
Ctr For the Surgl ArtsAltoonaPennsylvaniaIn reclutamento
Acute & Chronic Pain and Spine Center Ambulatory Surgery CenterAmarilloTexasIn reclutamento
Surgery Center of AmarilloAmarilloTexasIn reclutamento
Ames Surgery CenterAmesIowaIn reclutamento
Amherst Surgery CenterAmherstNew YorkIn reclutamento
Island Health HospitalAnacortesWashingtonIn reclutamento
Unicare Surgery CenterAnaheimCaliforniaIn reclutamento
AA Spine & Pain ClinicAnchorageAlaskaIn reclutamento
Memorial Hermann Surgery Center BrazoriaAngletonTexasIn reclutamento
Ann Arbor Surgl CtrAnn ArborMichiganIn reclutamento
East Ann Arbor Amb Surg and MedAnn ArborMichiganIn reclutamento
Univ of Michigan Univ HospAnn ArborMichiganIn reclutamento
Medstar Surg Ctr At AnnapolisAnnapolisMarylandIn reclutamento
Riva Road Surgery CenterAnnapolisMarylandIn reclutamento
Clearway Pain SolutionsAnnapolisMarylandIn reclutamento
AdventHealth OrlandoApopkaFloridaIn reclutamento

Nella scheda del registro sono indicati altri 2338 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 4 settembre 2026

    Centro aggiunto

    18 sites added (2388 total)

    23702388

  2. 1 settembre 2026

    Centro aggiunto

    1 site added (2370 total)

    23692370

  3. 18 agosto 2026

    Centro aggiunto

    1 site added (2369 total)

    23682369

  4. 10 agosto 2026

    Centro aggiunto

    25 sites added (2368 total)

    23432368

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

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