Cervical Disc Degenerative DisorderVCBM/ACDFNCT02182843
Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
A study testing Cellentra VCBM in people with Cervical Disc Degenerative Disorder, run by Zimmer Biomet at 6 sites in United States.
Trial summary
The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Disc Degenerative Disorder
- What is being tested?
- Cellentra VCBM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2014to Jan 2018
- 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
- The subject is scheduled to undergo a two or three level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using Cellentra™ VCBM, allograft spacers, and the MaxAn® Anterior Cervical Plate System.
- The subject is 18 years of age or older.
- The subject was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner.
- The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
- The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Who cannot join
- Subject has an active local or systemic infection.
- Subject is morbidly obese, defined as a BMI greater than 40.
- Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- Subject has inadequate tissue coverage over the operative site.
- Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis.
- Any previous cervical spinal surgery.
Show all 15Show fewer
- Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.) or immunocompromised.
- Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
- Subject who does not meet the specific indications for use of the Cellentra™ VCBM or MaxAn® Anterior Cervical Plate System.
- Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
- Subject is currently involved in another investigational drug or device study that could confound study data.
- Subject is a prisoner.
- Subject has a metal sensitivity/foreign body sensitivity.
- Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
- Subject has sensitivity or allergies to any of the processing agents. (See package insert for Cellentra™ VCBM).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ohio State University Wexner Medical Center
Columbus, Ohio, 43203
Fort Wayne Ortho
Fort Wayne, Indiana, 46804
Orthopaedic Institute of Western KY
Paducah, Kentucky, 42001
The Rothman Institute
Philadelphia, Pennsylvania, 19107
Barrow Neurological Associates
Phoenix, Arizona, 85013
Spine Team Texas
Southlake, Texas, 75032
About this study
The purpose of this study is to assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.
Read the detailed description
This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure.
- Conditions
- Cervical Disc Degenerative Disorder
- Being tested
- Cellentra VCBM
- Keywords
- Cellentra ACDF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellentra VCBMBiological
Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
| Study group | Role | What they receive |
|---|---|---|
| Cellentra VCBM | Experimental | Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects. Receives: Biological: Cellentra VCBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NDI From Baseline
Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.
Measured: 12 months after device implantation
Secondary outcomes (1)
Number of Participants With Radiographic Success at 24 Months
Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system:
- Grade I (definite) - Fused with remodeling and trabeculae
- Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies
- Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft
- Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse.
Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2018
- Study completionJan 2018
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.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc Degenerative DisorderStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Batts, Study director, Biomet Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182843
- Sponsor's protocol ID
- CS-092
- Acronym
- VCBM/ACDF
- Status last verified
- Feb 2019
- First submitted
- 2 Jul 2014
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gore DR, Sepic SB. Anterior cervical fusion for degenerated or protruded discs. A review of one hundred forty-six patients. Spine (Phila Pa 1976). 1984 Oct;9(7):667-71. doi: 10.1097/00007632-198410000-00002.
PubMed 6505833Palit M, Schofferman J, Goldthwaite N, Reynolds J, Kerner M, Keaney D, Lawrence-Miyasaki L. Anterior discectomy and fusion for the management of neck pain. Spine (Phila Pa 1976). 1999 Nov 1;24(21):2224-8. doi: 10.1097/00007632-199911010-00009.
PubMed 10562988McConnell JR, Freeman BJ, Debnath UK, Grevitt MP, Prince HG, Webb JK. A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion. Spine (Phila Pa 1976). 2003 Feb 15;28(4):317-23. doi: 10.1097/01.BRS.0000048503.51956.E1.
PubMed 12590203Samartzis D, Shen FH, Goldberg EJ, An HS. Is autograft the gold standard in achieving radiographic fusion in one-level anterior cervical discectomy and fusion with rigid anterior plate fixation? Spine (Phila Pa 1976). 2005 Aug 1;30(15):1756-61. doi: 10.1097/01.brs.0000172148.86756.ce.
PubMed 16094278Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
PubMed 7676341Soderlund CH, Pointillart V, Pedram M, Andrault G, Vital JM. Radiolucent cage for cervical vertebral reconstruction: a prospective study of 17 cases with 2-year minimum follow-up. Eur Spine J. 2004 Dec;13(8):685-90. doi: 10.1007/s00586-004-0747-8. Epub 2004 Jun 26.
PubMed 15662542Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
PubMed 17906571Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.
PubMed 20359958Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25.
PubMed 19632904Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.
PubMed 21699471Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
PubMed 24010901Lofgren H, Engquist M, Hoffmann P, Sigstedt B, Vavruch L. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up. Eur Spine J. 2010 Mar;19(3):464-73. doi: 10.1007/s00586-009-1161-z. Epub 2009 Sep 18.
PubMed 19763634Miller LE, Block JE. Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2045-50. doi: 10.1097/BRS.0b013e3181ff37eb.
PubMed 21304437Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007 Mar;6(3):198-209. doi: 10.3171/spi.2007.6.3.198.
PubMed 17355018
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)
- ClinicalTrials.gov ID
- NCT02182843
- Acronym / sponsor ID
- VCBM/ACDF / CS-092
- Conditions
- Cervical Disc Degenerative Disorder
- Keywords
- Cellentra ACDF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Posted 15 Mar 2019
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 assess the clinical and radiographic outcomes in patients who undergo ACDF procedures using Cellentra Viable Cell Bone Matrix (VCBM), cortical allograft spacers, and the MaxAn® Anterior Cervical Plate System. Cellentra VCBM will be compared to published data for autograft in NDI (Neck Disability Index) improvement and radiographic success of fusion.
Detailed description
This is a prospective single-arm multi-center study of Cellentra Viable Cell Bone Matrix (VCBM) and the MaxAn® Anterior Cervical Plate System when used in anterior cervical discectomy and fusion procedures. This study will enroll up to eighty (80) subjects across up to eight (8) clinical sites. Subjects will be recruited from a pool of patients presenting to investigators for an anterior cervical discectomy and fusion procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cellentra VCBM | Experimental | Biological: Cellentra VCBMCellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is scheduled to undergo a two or three level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using Cellentra™ VCBM, allograft spacers, and the MaxAn® Anterior Cervical Plate System.
- The subject is 18 years of age or older.
- The subject was unresponsive to conservative treatment for at least 6 weeks unless clinically indicated sooner.
- The subject has persistent neck, shoulder, or arm pain consistent with cervical degenerative disc disease confirmed by patient history and radiographic studies.
- The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Key exclusion criteria (15 listed)
- Subject has an active local or systemic infection.
- Subject is morbidly obese, defined as a BMI greater than 40.
- Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- Subject has inadequate tissue coverage over the operative site.
- Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis.
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 |
|---|---|---|
| Cellentra VCBMCellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects. | Biological | Cellentra VCBM |
Primary outcome
Change in NDI From Baseline
Time frame: 12 months after device implantation
Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.
1 secondary outcome
Number of Participants With Radiographic Success at 24 Months
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6505833Gore DR, Sepic SB. Anterior cervical fusion for degenerated or protruded discs. A review of one hundred forty-six patients. Spine (Phila Pa 1976). 1984 Oct;9(7):667-71. doi: 10.1097/00007632-198410000-00002.
- Background: PubMed 10562988Palit M, Schofferman J, Goldthwaite N, Reynolds J, Kerner M, Keaney D, Lawrence-Miyasaki L. Anterior discectomy and fusion for the management of neck pain. Spine (Phila Pa 1976). 1999 Nov 1;24(21):2224-8. doi: 10.1097/00007632-199911010-00009.
- Background: PubMed 12590203McConnell JR, Freeman BJ, Debnath UK, Grevitt MP, Prince HG, Webb JK. A prospective randomized comparison of coralline hydroxyapatite with autograft in cervical interbody fusion. Spine (Phila Pa 1976). 2003 Feb 15;28(4):317-23. doi: 10.1097/01.BRS.0000048503.51956.E1.
- Background: PubMed 16094278Samartzis D, Shen FH, Goldberg EJ, An HS. Is autograft the gold standard in achieving radiographic fusion in one-level anterior cervical discectomy and fusion with rigid anterior plate fixation? Spine (Phila Pa 1976). 2005 Aug 1;30(15):1756-61. doi: 10.1097/01.brs.0000172148.86756.ce.
- Background: PubMed 7676341Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.
- Background: PubMed 15662542Soderlund CH, Pointillart V, Pedram M, Andrault G, Vital JM. Radiolucent cage for cervical vertebral reconstruction: a prospective study of 17 cases with 2-year minimum follow-up. Eur Spine J. 2004 Dec;13(8):685-90. doi: 10.1007/s00586-004-0747-8. Epub 2004 Jun 26.
- Background: PubMed 17906571Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
- Background: PubMed 20359958Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010 Jun;10(6):469-74. doi: 10.1016/j.spinee.2010.02.007. Epub 2010 Apr 1.
- Background: PubMed 19632904Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25.
- Background: PubMed 21699471Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.
- Background: PubMed 24010901Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.
- Background: PubMed 19763634Lofgren H, Engquist M, Hoffmann P, Sigstedt B, Vavruch L. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up. Eur Spine J. 2010 Mar;19(3):464-73. doi: 10.1007/s00586-009-1161-z. Epub 2009 Sep 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joel Batts study director
Biomet Spine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellentra VCBM in people with Cervical Disc Degenerative Disorder, run by Zimmer Biomet at 6 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 5 inclusion and 15 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 15 Mar 2019). 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?
Change in NDI From Baseline (time frame: 12 months after device implantation). 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 NCT02182843, which also lists 14 linked publications.
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 15 Mar 2019.