NCT05504499

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Mar 2021Jan 2028

Study Start

First participant enrolled

March 19, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

6.8 years

First QC Date

August 11, 2022

Last Update Submit

August 16, 2022

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing

    The primary composite endpoint is individual patient success from baseline at 3- and 12-months of follow-up, which will be assessed as follows: 1. \> 20mm pain reduction in VAS Back while standing or walking 2. \> 20mm pain reduction in VAS Leg while standing or walking 3. Zurich Claudication Questionnaire improvement of 0.5 or greater in 2 or 3 domains) 4. ODI improvement of ≥ 10pts 5. No reoperations or revisions at the index level (s)

    12 months

Secondary Outcomes (6)

  • • To demonstrate real-world evidence of a significant improvement in the Pain Impact Score using ZIP™ as measured by the PROMIS-29 relative to baseline at 3 and 12 months.

    12 months

  • • To identify patterns related to the influence of pharmacologic agents on response to therapy (and vice versa).

    12 months

  • To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.

    12 months

  • Imaging analysis

    12 months

  • Complication Rate

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL

A Prospective, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain

Device: Interspinous Fusion

Interventions

Interspinous FusionDEVICE

The intended study population are adults 18 years or older with symptomatic lumbar degenerative disc disease resulting in back pain with lower extremity symptoms and neurogenic claudication that improves with spinal flexion who are candidates for use of the Zip™ MIS Interspinous Fusion device when undergoing spinal fixation procedures.

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must provide written informed consent prior to any clinical study-related procedure.
  • Subject is at least 18 years or older at the time of enrollment, skeletal mature.
  • Subject has 1-2 symptomatic lumbar degenerative disease at adjacent level, T12-S1, with or without grade I spondylolisthesis (confirmed by history and radiographic studies).
  • MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level
  • Subject has undergone at least 3 months of non-operative treatment.
  • Subject presents with ZCQ physical function ≥ 2.0 at baseline.
  • Subject reports relief from lumbar flexion and/or sitting.
  • Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.

You may not qualify if:

  • Subject is unable to provide written informed consent.
  • Subject has had previous lumbar spine surgery at the intended treatment level (e.g., laminectomy or fusion).
  • Subject has a grade II or greater spondylolisthesis on flexion and extension radiographs with 3mm instability.
  • Subject has confirmed or suspected osteoporosis or osteopenia.
  • Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
  • Subject is pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Evolve Restorative Center

Santa Rosa, California, 95403, United States

ACTIVE NOT RECRUITING

The Raso Pain Center

Jupiter, Florida, 33477, United States

RECRUITING

Koga Neurosurgery

Slidell, Louisiana, 70458, United States

RECRUITING

National Spine and Pain Centers

Oxon Hill, Maryland, 20745, United States

RECRUITING

Comprehensive & Interventional Pain Management

Henderson, Nevada, 89509, United States

RECRUITING

Nevada Advanced Pain Specialists

Reno, Nevada, 20745, United States

RECRUITING

Reno Tahoe Pain Associates

Reno, Nevada, 89509, United States

RECRUITING

The Pain Management Center

Voorhees Township, New Jersey, 08043, United States

RECRUITING

Premier Pain Treatment Institute

Loveland, Ohio, 45140, United States

RECRUITING

Center for Interventional Pain and Spine

Chadds Ford, Pennsylvania, 17601, United States

RECRUITING

Related Publications (1)

  • Falowski SM, Raso LJ, Mangal V, Narizi A, Patterson DG, Danko MD, Justiz R, Vogel RS, Koga S, Josephson Y, Pope JE. A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study. Pain Ther. 2023 Feb;12(1):187-199. doi: 10.1007/s40122-022-00447-0. Epub 2022 Oct 20.

    PMID: 36264409DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Shelley Trimm, BS

CONTACT

7075085527strimm@pacificresearchinstitute.care

Kam Murrell

CONTACT

267.818.9024kmurrell@pacificresearchinstitute.care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This clinical investigation is a prospective, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on patients undergoing interspinous interlaminar fusion with bone graft performed on an ambulatory basis by interventional pain physicians, orthopedic, and neurosurgeons, as normally performed in the real-world setting.
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 17, 2022

Study Start

March 19, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

US(10)