NCT03072927ClinicalTrials.gov
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
In brief
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…
Observational8,000 participants sought2,388 sites1 country
Categories
Registered in 1 registry
- ClinicalTrials.govNCT03072927Open this record at ClinicalTrials.govSynced 2 weeks ago
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Trial information is shown as published by the registry, in its original language.
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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.
- Present: Registered before enrolment beganFirst posted 2017-03-07; recorded start 2017-03-10
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: 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.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Stryker Instruments)
- Not stated: 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.
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.
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
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
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.
Summary
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.
Conditions
- Lumbar Spinal Stenosis
Eligibility
| Sex | All |
|---|---|
| Ages | 18 Years – No maximum |
| Healthy volunteers | No |
| Sampling method | PROBABILITY_SAMPLE |
Study population
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.
Eligibility as written in the registry
Eligibility in plain statements
This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.
Study design
| Study type | Observational |
|---|---|
| Phase | Not stated in the registry record |
| Allocation | Not stated in the registry record |
| Intervention model | Not stated in the registry record |
| Primary purpose | Not stated in the registry record |
| Masking | Not stated in the registry record |
| Enrolment | 8,000 participants sought |
Sponsor and collaborators
- Stryker Instruments Sponsor
Arms and 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
- Device Interspinous Process Decompression
Interspinous Process Decompression
- Device 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.
Outcome measures
Primary outcome
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.
Time frame 24 months
Primary outcome
Rate of surgical, minimally invasive intervention.
Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.
Time frame 24 months
Dates
| Start date | March 10, 2017 (actual) |
|---|---|
| Primary completion | December 1, 2026 (estimated) |
| Completion | December 1, 2026 (estimated) |
| First posted | March 7, 2017 (actual) |
| Last updated | September 4, 2026 |
| Results posted | Not stated in the registry record |
| Status last verified | January 2026 |
Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.
Locations
2,383 sites are recruiting
United States
| Facility | City | State or region | Status |
|---|---|---|---|
| Abilene Spine and Joint Surgery Center | Abilene | Texas | Recruiting |
| Hendrick Med Ctr South | Abilene | Texas | Recruiting |
| Abilene Ctr For Ortho and Multi | Abilene | Texas | Recruiting |
| Abington Memorial Hospital | Abington | Pennsylvania | Recruiting |
| Center for Spine Interventions ASC, LLC (ASC3) | Acworth | Georgia | Recruiting |
| Apex Surgery Center | Ada | Oklahoma | Recruiting |
| Ambulatory Surgical Institute of Dallas | Addison | Texas | Recruiting |
| Star Valley Med Ctr | Afton | Wyoming | Recruiting |
| Vidant Roanoke Chowan Hospital- Pain Management | Ahoskie | North Carolina | Recruiting |
| Aiken Regional Medical Center | Aiken | South Carolina | Recruiting |
| Parkwest Surgical Ctr | Akron | Ohio | Recruiting |
| Waverly Surgery Center | Albany | Oregon | Recruiting |
| Everett Road Surgery Center | Albany | New York | Recruiting |
| OrthoNY | Albany | New York | Recruiting |
| VA Medical Center | Albuquerque | New Mexico | Recruiting |
| University of New Mexico Hospital | Albuquerque | New Mexico | Recruiting |
| Outpatient Surg and Imaging Svcs | Albuquerque | New Mexico | Recruiting |
| Modern Pain & Spine PC | Albuquerque | New Mexico | Recruiting |
| Center for Pain Management Ambulatory Surgery, LLC | Alexandria | Minnesota | Recruiting |
| Pacific Ambulatory Surgery Center | Alhambra | California | Recruiting |
| Western PA Surg Ctr Beaver County | Aliquippa | Pennsylvania | Recruiting |
| Northaven Surg Ctr | Allen | Texas | Recruiting |
| Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | Recruiting |
| Surgery Center of Allentown | Allentown | Pennsylvania | Recruiting |
| Carepath Injury Ctr of Pennsylvania | Allentown | Pennsylvania | Recruiting |
| Cedar Crest Surg Ctr | Allentown | Pennsylvania | Recruiting |
| Aultman Alliance Community Hospital | Alliance | Ohio | Recruiting |
| Bacon County Hospital | Alma | Georgia | Recruiting |
| Pain Physicians of Atlanta | Alpharetta | Georgia | Recruiting |
| Advanced Asc | Altamonte Springs | Florida | Recruiting |
| Alton Memorial Hospital | Alton | Illinois | Recruiting |
| OSF Saint Anthony Medical Center | Alton | Illinois | Recruiting |
| Allegheny Surgery Center | Altoona | Pennsylvania | Recruiting |
| Oakleaf Surgl Hosp | Altoona | Wisconsin | Recruiting |
| Ctr For the Surgl Arts | Altoona | Pennsylvania | Recruiting |
| Acute & Chronic Pain and Spine Center Ambulatory Surgery Center | Amarillo | Texas | Recruiting |
| Surgery Center of Amarillo | Amarillo | Texas | Recruiting |
| Ames Surgery Center | Ames | Iowa | Recruiting |
| Amherst Surgery Center | Amherst | New York | Recruiting |
| Island Health Hospital | Anacortes | Washington | Recruiting |
| Unicare Surgery Center | Anaheim | California | Recruiting |
| AA Spine & Pain Clinic | Anchorage | Alaska | Recruiting |
| Memorial Hermann Surgery Center Brazoria | Angleton | Texas | Recruiting |
| Ann Arbor Surgl Ctr | Ann Arbor | Michigan | Recruiting |
| East Ann Arbor Amb Surg and Med | Ann Arbor | Michigan | Recruiting |
| Univ of Michigan Univ Hosp | Ann Arbor | Michigan | Recruiting |
| Medstar Surg Ctr At Annapolis | Annapolis | Maryland | Recruiting |
| Riva Road Surgery Center | Annapolis | Maryland | Recruiting |
| Clearway Pain Solutions | Annapolis | Maryland | Recruiting |
| AdventHealth Orlando | Apopka | Florida | Recruiting |
2,338 further sites are listed in the registry record.
Study documents
No documents are linked in this registry record.
Changes over time
- September 4, 2026
Site added
18 sites added (2388 total)
23702388
- September 1, 2026
Site added
1 site added (2370 total)
23692370
- August 18, 2026
Site added
1 site added (2369 total)
23682369
- August 10, 2026
Site added
25 sites added (2368 total)
23432368