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NCT03072927ClinicalTrials.gov

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Observationnelle8 000 participants recherchés2 388 sites1 pays

Catégories

Musculosquelettique100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Lumbar Spinal Stenosis

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon
Méthode d'échantillonnagePROBABILITY_SAMPLE

Population de l'étude

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.

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeObservationnelle
PhaseNon précisé dans la fiche du registre
RépartitionNon précisé dans la fiche du registre
Modèle d'interventionNon précisé dans la fiche du registre
Objectif principalNon précisé dans la fiche du registre
InsuNon précisé dans la fiche du registre
Recrutement8 000 participants recherchés

Promoteur et collaborateurs

  • Stryker Instruments Promoteur

Groupes et interventions

  • 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.

Interventions

  • Dispositif Interspinous Process Decompression

    Interspinous Process Decompression

  • Dispositif 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.

Critères de jugement

  1. Critère de jugement 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.

    Délai 24 months

  2. Critère de jugement 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.

    Délai 24 months

Dates

Date de début10 mars 2017 (réelle)
Achèvement principal1 décembre 2026 (estimée)
Achèvement1 décembre 2026 (estimée)
Première publication7 mars 2017 (réelle)
Dernière mise à jour4 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjanvier 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

2 383 sites sont en recrutement

United States

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

2 338 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 4 septembre 2026

    Site ajouté

    18 sites added (2388 total)

    23702388

  2. 1 septembre 2026

    Site ajouté

    1 site added (2370 total)

    23692370

  3. 18 août 2026

    Site ajouté

    1 site added (2369 total)

    23682369

  4. 10 août 2026

    Site ajouté

    25 sites added (2368 total)

    23432368

Registre: ClinicalTrials.gov · NCT########

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