MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

NCT00956631

Lumbar Spinal Stenosis

COMPLETED PHASE4

MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

NCT01315145

Lumbar Spinal Stenosis

COMPLETED NA

Vertos Mild - Post Market Patient Outcomes

NCT01076244

Lumbar Spinal Stenosis

COMPLETED NA

The Vertos MILD™ Preliminary Patient Evaluation Study

NCT00749073

Lumbar Spinal Stenosis

COMPLETED NA

Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

NCT01129921

Lumbar Spine Stenosis Central Canal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spinal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lumbar decompression

Percutaneous lumbar decompression with mild® Device Kit.

Group Type OTHER

lumbar decompression

Intervention Type PROCEDURE

The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lumbar decompression

The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

The mild® Device Kit

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
* Prior failure of conservative therapy and Oswestry Disability Index (ODI) score \> 20%.
* Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically \> 2.5 mm), confirmed by pre-op MRI and/or CT.
* Central canal cross sectional area clearly reduced per MRI/CT report.
* If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
* Able to walk at least 10 feet unaided before being limited by pain.
* Available to complete 26 weeks of follow-up.
* A signed Informed Consent Form is obtained from the patient.
* Adults at least 18 years of age.

Exclusion Criteria

* Prior surgery at intended treatment level.
* Compound fracture with interspinal retropulsion contributing to spinal stenosis.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
* Disc protrusion or osteophyte formation severe enough to confound study outcome.
* Facet hypertrophy severe enough to confound study outcome.
* Bleeding disorders and/or current use of anti-coagulants.
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
* Epidural steroid administration within prior three weeks (of procedure).
* Inability of the patient to lie prone for any reason with anesthesia support (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).
* Metabolic wound healing pathologies deemed by Investigator to compromise study outcomes.
* Dementia and/or inability to give informed consent.
* Pregnant and/or breastfeeding.
* On Workman's Compensation or considering litigation associated with back pain.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No