Cervical Degenerative Disc DisorderNCT03123549

Investigation of the Two Level Simplify® Cervical Artificial Disc

A study testing Simplify Disc in people with Cervical Degenerative Disc Disorder, run by NuVasive at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cervical Degenerative Disc Disorder
What is being tested?: Simplify Disc
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 18 sitesUnited States
Study dates: 1 Apr 2017to 24 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;
Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management;
Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s);
Must be at least 18 years of age and be skeletally mature at the time of surgery;
Has a preoperative Neck Disability Index (NDI) ≥ 30;

Show all 9Show fewer

Has a preoperative neck pain score > 8 based on the preoperative Neck and Arm Pain Questionnaire;
If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
Is willing to comply with the study plan and sign the Patient Informed Consent Form.

Who cannot join

Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
Sagittal plane translation > 3.5 mm, or
Sagittal plane angulation > 20°;
Has more than two cervical levels requiring surgical treatment;
Has a fused level (or artificial disc replacement) adjacent to the levels to be treated;

Show all 30Show fewer

Has severe pathology of the facet joints of the involved vertebral bodies;
Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels;
Axial neck pain only (no radicular or myelopathy symptoms);
Has been previously diagnosed with osteopenia or osteomalacia;
Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility):
Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds;
Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture;
Male over the age of 70;
Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
If the level of bone mineral density is a T score of -1.5 or lower (i.e., -1.6, 1.7, etc.), then the patient is excluded from the study
Has presence of spinal metastases;
Has overt or active bacterial infection, either local or systemic;
Has insulin-dependent diabetes;
Has chronic or acute renal failure or prior history of renal disease;
Known PEEK, ceramic, titanium allergy;
Is mentally incompetent (if questionable, obtain psychiatric consult);
Is a prisoner;
Is pregnant;
Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;
Is involved with current or pending litigation regarding a spinal condition;
Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs);
Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Texas Spine Consultants
Addison, Texas, 75001
Indiana Spine Group
Carmel, Indiana, 46032
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
NorthShore University Health System
Evanston, Illinois, 60201
Parkview Research Center
Fort Wayne, Indiana, 46845
Connecticut Orthopaedic Specialists
Hamden, Connecticut, 06518
Buffalo Spine Surgery
Lockport, New York, 14094
Orthopaedic Education and Research Institute of Southern California
Orange, California, 92868
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42003
Texas Back Institute
Plano, Texas, 75093
Virginia Spine Institute
Reston, Virginia, 20191
William Beaumont Hospital
Royal Oak, Michigan, 48073
The Spine Institute for Spine Restoration
Santa Monica, California, 90403
Kennedy-White orthopedic Center
Sarasota, Florida, 34232
Spine institute of Louisiana
Shreveport, Louisiana, 71101
Oregon Neurosurgery
Springfield, Oregon, 97477
Spine Education and Research Foundation
Thornton, Colorado, 80229
The Disc Replacement Center
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc

This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.

Read the detailed description

The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Simplify® Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces that are unresponsive to conservative management.

Conditions: Cervical Degenerative Disc Disorder
Being tested: Simplify Disc

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Simplify DiscDevice
Simplify Disc at two levels of the cervical spine

Study groups in NCT03123549
Study group	Role	What they receive
Simplify Disc	Experimental	Simplify Disc at two levels of the cervical spine Receives: Device: Simplify Disc
Historical Control	No intervention	This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm of a previously completed two level cervical disc trial.

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Clinical Success (CCS) Rate of the Simplify® Disc
Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no additional surgical procedure at the index level within 24 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 24 months.
NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.
Measured: 24 Months

Secondary outcomes (15)

Neurological Status
Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, and myelopathic gait to make an adjudication determination.
Measured: Baseline, 24mos
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)
Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.
Measured: Baseline, 3mos
Neck Pain Intensity Questionnaire
Changes of at least 2 points on a 10-point scale will be regarded as clinically significant (0=no pain; 10=worst pain)
Measured: Baseline, 24mos.
Arm Pain Intensity Questionnaire
Changes of at least 2 points on a 10-point scale will be regarded as clinically significant (0=no pain; 10=worst pain)
Measured: Baseline, 24mos.
Patient Questionnaires- Treatment Satisfaction Survey
Question 1 - "I am satisfied with the results of my surgery" was compared between groups at Month 24. Answer options ranged from definitely true to definitely false.
Measured: Baseline, 24mos.
SF-36v2 Health Survey Physical Component Score (PCS) Maintenance or Improvement
The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.
Measured: Baseline, 24mos
SF-36 Mental Component Score (MCS) Maintenance or Improvement
The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as MCS(Postop) - MCS(Preop) ≥0.
Measured: Baseline, 24mos.
Dysphagia Handicap Index (DHI)
Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100.
Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24mos.
Physician's Perception of Results
Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to their perception of the results. Available responses include excellent, good, fair, and poor. Maintenance or improvement was defined as either maintenance of the assigned preoperative grade or any shift to a more favorable grade postoperatively (e.g. poor to fair, fair to good).
Measured: Baseline, 24mos.
Change in Average Disc Height (Superior Index Level)
Average disc height (superior index level) at 24 months was compared to the baseline measurement and the change was calculated. Measurements were scored by an independent core lab. Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Data was not collected on disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24mos.
Change in Average Disc Height (Inferior Index Level)
Average disc height (inferior index level) at 24 months was compared to the baseline measurement and the change was calculated. Measurements were scored by an independent core lab. Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Data was not collected on disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24M
Superior Adjacent Level Disc Degeneration (ALDD)
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space), indeterminate, or unable to assess.
Data was not collected on ALDD in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24mos.
Inferior Adjacent Level Disc Degeneration (ALDD)
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space), indeterminate, or unable to assess.
Data was not collected on ALDD in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24mos.
Facet Degeneration (Superior Index Level)
Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Degeneration was graded as none (normal facet joint space), mild (narrowing of the facet joint space and / or small osteophytes and / or mild hypertrophy of the articular process), moderate (narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and / or mild subarticular bone erosions), severe (Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts), indeterminate, or unable to assess.
Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.
Measured: Baseline, 24mos.
Facet Degeneration (Inferior Index Level)
Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Degeneration was graded as none (normal facet joint space), mild (narrowing of the facet joint space and / or small osteophytes and / or mild hypertrophy of the articular process), moderate (narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and / or mild subarticular bone erosions), severe (Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts), indeterminate, or unable to assess.
Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.
Measured: Baseline, 24mos.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201724 Mar 2022

First posted21 Apr 2017
Study start1 Apr 2017
Primary completion12 Nov 2020
Study completion24 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cervical Degenerative Disc DisorderStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03123549
Sponsor's protocol ID: G150206
Status last verified: Dec 2025
First submitted: 29 Mar 2017
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Assessing Microbiome in Primary Anterior Cervical Fusion Patients
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RecruitingObservational study
PMCF Study Fortilink-SC
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Enrolling by invitation
Physiotherapy and Osteopathic Treatment for Pain in the Cervical and Lumbar Spine and Temporomandibular Joints
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Recruiting
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All Cervical Degenerative Disc Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc
ClinicalTrials.gov ID: NCT03123549
Acronym / sponsor ID: G150206
Conditions: Cervical Degenerative Disc Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: NuVasiveIndustry (pharma, biotech, devices)
Study start: 1 Apr 2017 (actual)
Primary completion: 12 Nov 2020 (actual)
Study completion: 24 Mar 2022 (actual)
First posted: 21 Apr 2017 (actual)
Results: Posted 6 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Simplify Disc	Experimental	Device: Simplify DiscSimplify Disc at two levels of the cervical spine
Historical Control	No intervention	–This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm of a previously completed two level cervical disc trial.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;
Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management;
Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s);
Must be at least 18 years of age and be skeletally mature at the time of surgery;

Key exclusion criteria (30 listed)

Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
Has more than two cervical levels requiring surgical treatment;
Has a fused level (or artificial disc replacement) adjacent to the levels to be treated;
Has severe pathology of the facet joints of the involved vertebral bodies;

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
Simplify DiscSimplify Disc at two levels of the cervical spine	Device	Simplify Disc

Primary outcome

Composite Clinical Success (CCS) Rate of the Simplify® Disc
Time frame: 24 Months
Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no additional surgical procedure at the index level within 24 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 24 months. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.

15 secondary outcomes

Neurological Status
Time frame: Baseline, 24mos
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)
Time frame: Baseline, 3mos
Neck Pain Intensity Questionnaire
Time frame: Baseline, 24mos.
Arm Pain Intensity Questionnaire
Time frame: Baseline, 24mos.
Patient Questionnaires- Treatment Satisfaction Survey
Time frame: Baseline, 24mos.
SF-36v2 Health Survey Physical Component Score (PCS) Maintenance or Improvement
Time frame: Baseline, 24mos
SF-36 Mental Component Score (MCS) Maintenance or Improvement
Time frame: Baseline, 24mos.
Dysphagia Handicap Index (DHI)
Time frame: Baseline, 24mos.
Physician's Perception of Results
Time frame: Baseline, 24mos.
Change in Average Disc Height (Superior Index Level)
Time frame: Baseline, 24mos.
Change in Average Disc Height (Inferior Index Level)
Time frame: Baseline, 24M
Superior Adjacent Level Disc Degeneration (ALDD)
Time frame: Baseline, 24mos.
Inferior Adjacent Level Disc Degeneration (ALDD)
Time frame: Baseline, 24mos.
Facet Degeneration (Superior Index Level)
Time frame: Baseline, 24mos.
Facet Degeneration (Inferior Index Level)
Time frame: Baseline, 24mos.

Results and safety

Results posted to the registry on 6 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simplify Disc	182	168
Historical Control - Anterior Cervical Discectomy and Fusion (ACDF)	170	127

Primary outcome: Composite Clinical Success (CCS) Rate of the Simplify® Disc

Time frame: 24 Months. Count of participants. Unit: Participants

Measure	Simplify Disc n = 173	Historical Control n = 145
Value	153	105

Simplify Disc vs Historical Control: p = 0.017, t-test, 1 sided

Population analysed: While 168 Simplify Disc subjects and 127 historical control subjects were considered completers for subject accounting purposes, 173 (Simplify Disc) and 145 (ACDF) subjects were evaluable for composite clinical success. This is due to the fact that some subjects were known failures prior to the 24-month visit.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simplify Disc	32 of 182 (17.6%)	96 of 182 (52.7%)	2 of 182
Historical Control - Anterior Cervical Discectomy and Fusion (ACDF)	62 of 170 (36.5%)	145 of 170 (85.3%)	1 of 170

Limitations and caveats (from the sponsor): ACDF data is presented as a historical control fusion group from a previously completed IDE trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Simplify Medical Website for the Simplify Disc TrialLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Cervical Degenerative Disc Disorder

Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
Enrolling by invitation
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Recruiting
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Degenerative Disc Disease

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. This study is not recruiting at the moment.

Kyle Malone study director

NuVasive

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Simplify Disc in people with Cervical Degenerative Disc Disorder, run by NuVasive at 18 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 30 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

Yes. Results are posted in the registry (first posted 6 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Clinical Success (CCS) Rate of the Simplify® Disc (time frame: 24 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 NCT03123549.

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 8 Jan 2026.