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NCT03072927ClinicalTrials.gov

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

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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…

Beobachtend8.000 Teilnehmende gesucht2.388 Studienzentren1 Land

Kategorien

Bewegungsapparat100%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

  • Lumbar Spinal Stenosis

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein
StichprobenverfahrenPROBABILITY_SAMPLE

Studienpopulation

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.

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypBeobachtend
PhaseIm Registereintrag nicht angegeben
ZuteilungIm Registereintrag nicht angegeben
InterventionsmodellIm Registereintrag nicht angegeben
Primäres ZielIm Registereintrag nicht angegeben
VerblindungIm Registereintrag nicht angegeben
Teilnahme8.000 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Stryker Instruments Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Medizinprodukt Interspinous Process Decompression

    Interspinous Process Decompression

  • Medizinprodukt 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.

Endpunkte

  1. Primärer Endpunkt

    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.

    Zeitrahmen 24 months

  2. Primärer Endpunkt

    Rate of surgical, minimally invasive intervention.

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

    Zeitrahmen 24 months

Daten

Startdatum10. März 2017 (tatsächlich)
Primärer Abschluss1. Dezember 2026 (geschätzt)
Abschluss1. Dezember 2026 (geschätzt)
Erstveröffentlichung7. März 2017 (tatsächlich)
Zuletzt aktualisiert4. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtJanuar 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

2.383 Studienzentren rekrutieren

United States

EinrichtungStadtBundesland oder RegionStatus
Abilene Spine and Joint Surgery CenterAbileneTexasRekrutiert
Hendrick Med Ctr SouthAbileneTexasRekrutiert
Abilene Ctr For Ortho and MultiAbileneTexasRekrutiert
Abington Memorial HospitalAbingtonPennsylvaniaRekrutiert
Center for Spine Interventions ASC, LLC (ASC3)AcworthGeorgiaRekrutiert
Apex Surgery CenterAdaOklahomaRekrutiert
Ambulatory Surgical Institute of DallasAddisonTexasRekrutiert
Star Valley Med CtrAftonWyomingRekrutiert
Vidant Roanoke Chowan Hospital- Pain ManagementAhoskieNorth CarolinaRekrutiert
Aiken Regional Medical CenterAikenSouth CarolinaRekrutiert
Parkwest Surgical CtrAkronOhioRekrutiert
Waverly Surgery CenterAlbanyOregonRekrutiert
Everett Road Surgery CenterAlbanyNew YorkRekrutiert
OrthoNYAlbanyNew YorkRekrutiert
VA Medical CenterAlbuquerqueNew MexicoRekrutiert
University of New Mexico HospitalAlbuquerqueNew MexicoRekrutiert
Outpatient Surg and Imaging SvcsAlbuquerqueNew MexicoRekrutiert
Modern Pain & Spine PCAlbuquerqueNew MexicoRekrutiert
Center for Pain Management Ambulatory Surgery, LLCAlexandriaMinnesotaRekrutiert
Pacific Ambulatory Surgery CenterAlhambraCaliforniaRekrutiert
Western PA Surg Ctr Beaver CountyAliquippaPennsylvaniaRekrutiert
Northaven Surg CtrAllenTexasRekrutiert
Lehigh Valley Hospital - Cedar CrestAllentownPennsylvaniaRekrutiert
Surgery Center of AllentownAllentownPennsylvaniaRekrutiert
Carepath Injury Ctr of PennsylvaniaAllentownPennsylvaniaRekrutiert
Cedar Crest Surg CtrAllentownPennsylvaniaRekrutiert
Aultman Alliance Community HospitalAllianceOhioRekrutiert
Bacon County HospitalAlmaGeorgiaRekrutiert
Pain Physicians of AtlantaAlpharettaGeorgiaRekrutiert
Advanced AscAltamonte SpringsFloridaRekrutiert
Alton Memorial HospitalAltonIllinoisRekrutiert
OSF Saint Anthony Medical CenterAltonIllinoisRekrutiert
Allegheny Surgery CenterAltoonaPennsylvaniaRekrutiert
Oakleaf Surgl HospAltoonaWisconsinRekrutiert
Ctr For the Surgl ArtsAltoonaPennsylvaniaRekrutiert
Acute & Chronic Pain and Spine Center Ambulatory Surgery CenterAmarilloTexasRekrutiert
Surgery Center of AmarilloAmarilloTexasRekrutiert
Ames Surgery CenterAmesIowaRekrutiert
Amherst Surgery CenterAmherstNew YorkRekrutiert
Island Health HospitalAnacortesWashingtonRekrutiert
Unicare Surgery CenterAnaheimCaliforniaRekrutiert
AA Spine & Pain ClinicAnchorageAlaskaRekrutiert
Memorial Hermann Surgery Center BrazoriaAngletonTexasRekrutiert
Ann Arbor Surgl CtrAnn ArborMichiganRekrutiert
East Ann Arbor Amb Surg and MedAnn ArborMichiganRekrutiert
Univ of Michigan Univ HospAnn ArborMichiganRekrutiert
Medstar Surg Ctr At AnnapolisAnnapolisMarylandRekrutiert
Riva Road Surgery CenterAnnapolisMarylandRekrutiert
Clearway Pain SolutionsAnnapolisMarylandRekrutiert
AdventHealth OrlandoApopkaFloridaRekrutiert

2.338 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 4. September 2026

    Studienzentrum hinzugefügt

    18 sites added (2388 total)

    23702388

  2. 1. September 2026

    Studienzentrum hinzugefügt

    1 site added (2370 total)

    23692370

  3. 18. August 2026

    Studienzentrum hinzugefügt

    1 site added (2369 total)

    23682369

  4. 10. August 2026

    Studienzentrum hinzugefügt

    25 sites added (2368 total)

    23432368

Register: ClinicalTrials.gov · NCT########

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