Lumbar Spinal StenosisRefineNCT05504499
REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
A study testing Interspinous Fusion in people with Lumbar Spinal Stenosis, run by Pacific Research Institute at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Interspinous Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Mar 2021to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects enrolled in this study must meet ALL of the following inclusion criteria:
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Subjects enrolled in this study must NOT meet any of the following exclusion criteria:
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 9 recruiting
- Recruiting
Center for Interventional Pain and Spine
Chadds Ford, Pennsylvania, 17601
Ashley Scherer, 844-365-7246, ashleys@centerisp.com
Ashley K, 844.365.7246, ashleyk@centerisp.com
- Recruiting
Comprehensive & Interventional Pain Management
Henderson, Nevada, 89509
Shepard Urban, 702-990-4530, shepardurbahnpac@cipmnv.com
Rainer Vogel, MD
- Recruiting
The Raso Pain Center
Jupiter, Florida, 33477
Jodie Laprade, 561-264-2929, teamrasojodie@aol.com
Louis Raso, MD
- Recruiting
Premier Pain Treatment Institute
Loveland, Ohio, 45140
Kathy White, 513-454-7246, kwhite@premierpaintreatment.com
Michael Danko, MD
- Recruiting
National Spine and Pain Centers
Oxon Hill, Maryland, 20745
Diamond Wilson, 301-485-7400, DWilson@treatingpain.com
Vipul Mangal, MD
- Recruiting
Nevada Advanced Pain Specialists
Reno, Nevada, 20745
Rachel Yetter, 775-284-8650, rachael@nvadvancedpain.com
Denis Patterson, DO
- Recruiting
Reno Tahoe Pain Associates
Reno, Nevada, 89509
Maria Peregrina, 775-236-8596, peregrina@rtpain.net
Ali Nairizi, MD
- Active, not recruiting
Evolve Restorative Center
Santa Rosa, California, 95403
- Recruiting
Koga Neurosurgery
Slidell, Louisiana, 70458
Rachel Englert, RN, 985-269-7676, rachel@koga.clinic
Sebastian Koga, MD
- Recruiting
The Pain Management Center
Voorhees Township, New Jersey, 08043
Onoshoze Bossey, 609-382-0392, Onoshoze.Bossey@prospirapc.com
Youseff Josephson, MD
About this study
Official title: REFINE Study: 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
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.
Read the detailed description
INTRODUCTION
This study will evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in single-level fusion in patients with chronic low back pain that present with degenerative disc disease (DDD) with concurrent neurogenic claudication.
Devices included in study are the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material. The device is a bilateral locking plate system which attaches to the spinous processes of the posterior noncervical spine (T1-S1) from an interlaminar approach. The implants have superior and inferior spinous process articulations and a central bone graft chamber.
The Aurora Spine ZIP™ is used to treat DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The studied indication is lumbar degenerative disease resulting in back pain with lower extremity symptoms and neurogenic claudication.
Degenerative disc disease is a common condition of the aging spine, and may contribute to a variety of painful symptoms, including radiculopathy, neurogenic claudication, and back pain. There are a number of mechanical sequelae that result from these degenerative processes of the intervertebral disc, which may manifest in the anterior, middle, and posterior columns of the spine. Symptoms of degenerative disc disease have traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural steroid injections) and invasive (surgical decompression and/or fusion) options(1,2). Interspinous spacers (ISS) have been proven to be effective for neurogenic claudication with 5 year outcome data and robust clinical experience (3). More invasive treatment options for lumbar spinal stenosis include decompressive laminectomies and a variety of approaches to lumbar fusion.
Direct comparison of two year results of ISS and decompressive laminectomies found ISS offers a less invasive treatment that reduces the potential for comorbidities, necessity for future operations, and is less disruptive to the spinal anatomy providing greater options for future surgical interventions with equivalent clinical outcomes (4). The landmark multicenter SPORT trial compared decompressive laminectomy to conservative non-operative care in patients with spinal stenosis with neurogenic claudication and found that the surgical group had significantly greater improvement in pain and function at four-year follow-up (5).
A meta-analysis of lumbar fusions for degenerative diseases looked at patient reported outcomes from 65 studies including disability, pain scores, and patient satisfaction. Fusion has been shown to be evidenced for spondylolisthesis, and patients who were randomly assigned to fusion care were 4 times as likely to be satisfied, attained 34% greater pain relief and saw a 40% improvement of preoperative disability when compared to those who received non-operative care (2). Evidence for fusion for stenosis without spondylolisthesis is limited in this meta-analysis, however this did not distinguish among fusion approaches.
Fusion did provide greater relief than non-operative care in patients with chronic low back pain without clinically significant stenosis or spondylolisthesis (2). Five randomized control trials reported results with fusion between 16-18% improved in terms of back and leg pain as compared to non-operative care (2). Anterior interbody fusion (ABF) and posterolateral fusion with pedicle screws (PLF) in patients with discogenic low back pain resulted in a significant decrease in VAS pain scores, with greatest relief following ABF, compared to conservative treatment (6).
3 STUDY PURPOSE
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 single-level fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Interspinous Fusion
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Interspinous Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- > 20mm pain reduction in VAS Back while standing or walking
- > 20mm pain reduction in VAS Leg while standing or walking
- Zurich Claudication Questionnaire improvement of 0.5 or greater in 2 or 3 domains)
- ODI improvement of ≥ 10pts
- No reoperations or revisions at the index level (s)
Measured: 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.
- PROMIS-29 Subjects will be asked improvement based on Not at all, A little bit, Somewhat, Quite a bit, Very Much
- Pain Impact Score (calculated from PROMIS-29)
Measured: 12 months
• To identify patterns related to the influence of pharmacologic agents on response to therapy (and vice versa).
Change in use of pain medications related to initial lumbar pathology
Measured: 12 months
To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.
Subjects will be asked if their overall pain since study treatment was very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse
Measured: 12 months
Imaging analysis
Xray 12 months
Measured: 12 months
Complication Rate
No major implant or procedure-related complications
Measured: 12 months
Complication Rate
Spinous process fracture rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start19 Mar 2021
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504499
- Sponsor's protocol ID
- AUR-ZIP-01
- Acronym
- Refine
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36264409
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFINE Study: 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
- ClinicalTrials.gov ID
- NCT05504499
- Acronym / sponsor ID
- Refine / AUR-ZIP-01
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pacific Research InstituteResearch network
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION
This study will evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in single-level fusion in patients with chronic low back pain that present with degenerative disc disease (DDD) with concurrent neurogenic claudication.
Devices included in study are the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material. The device is a bilateral locking plate system which attaches to the spinous processes of the posterior noncervical spine (T1-S1) from an interlaminar approach. The implants have superior and inferior spinous process articulations and a central bone graft chamber.
The Aurora Spine ZIP™ is used to treat DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The studied indication is lumbar degenerative disease resulting in back pain with lower extremity symptoms and neurogenic claudication.
Degenerative disc disease is a common condition of the aging spine, and may contribute to a variety of painful symptoms, including radiculopathy, neurogenic claudication, and back pain. There are a number of mechanical sequelae that result from these degenerative processes of the intervertebral disc, which may manifest in the anterior, middle, and posterior columns of the spine. Symptoms of degenerative disc disease have traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural steroid injections) and invasive (surgical decompression and/or fusion) options(1,2). Interspinous spacers (ISS) have been proven to be effective for neurogenic claudication with 5 year outcome data and robust clinical experience (3). More invasive treatment options for lumbar spinal stenosis include decompressive laminectomies and a variety of approaches to lumbar fusion.
Direct comparison of two year results of ISS and decompressive laminectomies found ISS offers a less invasive treatment that reduces the potential for comorbidities, necessity for future operations, and is less disruptive to the spinal anatomy providing greater options for future surgical interventions with equivalent clinical outcomes (4). The landmark multicenter SPORT trial compared decompressive laminectomy to conservative non-operative care in patients with spinal stenosis with neurogenic claudication and found that the surgical group had significantly greater improvement in pain and function at four-year follow-up (5).
A meta-analysis of lumbar fusions for degenerative diseases looked at patient reported outcomes from 65 studies including disability, pain scores, and patient satisfaction. Fusion has been shown to be evidenced for spondylolisthesis, and patients who were randomly assigned to fusion care were 4 times as likely to be satisfied, attained 34% greater pain relief and saw a 40% improvement of preoperative disability when compared to those who received non-operative care (2). Evidence for fusion for stenosis without spondylolisthesis is limited in this meta-analysis, however this did not distinguish among fusion approaches.
Fusion did provide greater relief than non-operative care in patients with chronic low back pain without clinically significant stenosis or spondylolisthesis (2). Five randomized control trials reported results with fusion between 16-18% improved in terms of back and leg pain as compared to non-operative care (2). Anterior interbody fusion (ABF) and posterolateral fusion with pedicle screws (PLF) in patients with discogenic low back pain resulted in a significant decrease in VAS pain scores, with greatest relief following ABF, compared to conservative treatment (6).
3 STUDY PURPOSE
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 single-level fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Interspinous FusionA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects enrolled in this study must meet ALL of the following inclusion criteria:
Key exclusion criteria (8 listed)
- Subjects enrolled in this study must NOT meet any of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interspinous FusionThe 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. | Device | Single Arm |
Primary outcome
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
Time frame: 12 months
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)
6 secondary outcomes
• 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.
Time frame: 12 months
• To identify patterns related to the influence of pharmacologic agents on response to therapy (and vice versa).
Time frame: 12 months
To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.
Time frame: 12 months
Imaging analysis
Time frame: 12 months
Complication Rate
Time frame: 12 months
Complication Rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 36264409Falowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interspinous Fusion in people with Lumbar Spinal Stenosis, run by Pacific Research Institute at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelley Trimm, BS (7075085527, strimm@pacificresearchinstitute.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.