Intervertebral Disc DegenerationNCT02586116

Comparison of nanOss Cervical IBF System to C-Plus PEEK IBF Device With Autograft

A study testing nanOss and C-Plus in people with Intervertebral Disc Degeneration, run by RTI Surgical at 1 site in Belgium.

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 21 years and older
Conditions the study is for: Intervertebral Disc Degeneration
What is being tested?: nanOss and C-Plus
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteBelgium
Study dates: Oct 2015to Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is at least 21 years of age and skeletally mature.
Must have cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one level in the cervical spine between C3 to T1.
Must have completed a minimum of six weeks of unsuccessful conservative, non- operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (AP/LAT/FLX/EXT X-rays \& a recent MRI)
Is willing and able to comply with all clinical investigation visits and procedures including screening treatment procedures, post-operative management, the follow-up schedule and completion of forms or questionnaires.
Is able to understand and sign the informed consent document

Who cannot join

Requires fusion at more than one level
Has had prior fusion at the level to be treated.
Has a metabolic or systemic bone disorder.
Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease)
Has a systemic or local infection (active or latent)
Has acute or chronic infections in the surgical area (i.e., soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis)

Show all 15Show fewer

chronic use of steroids, other than episodic use or inhaled corticosteroids
has any significant general illness (i.e. tested positive for HIV, Hepatitis B or Hepatitis C, has active metastatic cancer of any type, uncontrolled diabetes Type I, dialysis dependent renal failure, symptomatic liver disease)
has a mental or physical condition that would limit the ability to comply with study requirements or would preclude accurate evaluation.
Is immunocompromised or being treated with immunosuppressive agents (including chemotherapy or radiation treatment).
has documented allergies to hydroxyapatite or porcine collagen, PEEK, titanium, titanium alloy or tantalum.
currently pregnant, or interested in becoming pregnant during the clinical investigation follow-up
is a smoker
is a prisoner
is currently involved in another drug or device clinical investigation that may confound the clinical investigation data.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ziekenhuis Oost Limburg
Genk, 3600

Other trials in Belgium

About this study

Official title: Post Market Comparison of nanOss Cervical Interbody Fusion System to C-Plus Interbody Fusion Device With Autograft

This is a post-market, prospective, randomized clinical investigation to evaluate the performance of the nanOss Cervical Interbody Fusion (IBF) device with nanOss Bioactive Bone Void Filler for the treatment of cervical disc disease. A secondary objective is to compare the performance of the nanOss Cervical IBF Device and nanOss Bioactive Bone Void Filler with the performance of the C-Plus PEEK IBF Device with autograft. This study will enroll 40 patients at one (1) site. After subjects have signed an informed consent, they will be randomly assigned to either the nanOss Cervical IBF device arm or the C-Plus PEEK IBF Device. Patients will complete the preoperative visit and examinations. Patients will be evaluated at discharge, six (6) weeks, three (3) months, six (6) months, and twelve (12) months. Patients will be evaluated at twenty-four (24) months post-operatively if they have not demonstrated fusion at the 12 month time point.

Read the detailed description

The nanOss Cervical Interbody Fusion Device is CE-marked for single level intervertebral body fusion from C3 to T1 for the treatment of cervical disc disease. The nanOss IBF device is designed to be used as one device per level, with graft material and supplemental fixation.

nanOss BABone Void Filler is a resorbable porous calcium phosphate bone void filler for use as a bone graft substitute or bone void filler. It is CE marked for use as a bone void filler in the spine, and it is to be re-hydrated with Bone Marrow Aspirate (BMA) alone, or a mixture of the patient's BMA and autograft.

The C-Plus PEEK IBF Device is indicated for use in skeletally mature adults at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease. The device is to be used in patients who have had six weeks of non-operative treatment. Autogenous bone graft is placed within the central cavity of the C-Plus PEEK IBF Device.

The SlimFuse Cervical Plate System components are titanium alloy plates and screws designed to temporarily provide resistance to flexion, extension, lateral bending and axial rotation with strength and stiffness in the cervical spine (C2-C7) in order to promote cervical fusion. The anterior approach should be used when implanting the SlimFuse Cervical Plate System.

The primary goal of this study is to evaluate the outcomes between nanOss Cervical IBF Device and C-Plus PEEK IBF Device. The primary endpoint will be objectively determined via x-rays and CT scan to assess fusion. Secondary endpoints will include subjective patient scores for neck and arm pain and quality of life along with analysis of the proportion of patients who experience a treatment failure.

Conditions: Intervertebral Disc Degeneration
Being tested: nanOss, C-Plus
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

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

nanOssDevice
Also called nanOss Cervical IBF Device
nanOss Cervical Interbody Fusion Device with nanOss BA bone void filler.
C-PlusDevice
Also called C-Plus PEEK IBF Device
C-Plus PEEK IBF Device with autograft

Study groups in NCT02586116
Study group	Role	What they receive
nanOss	Active comparator	nanOss Cervical IBF System with nanOss BA Bone Void Filler Receives: Device: nanOss
C-Plus	Active comparator	C-Plus PEEK IBF Device with autograft Receives: Device: C-Plus

What is being measured

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

Number of patients demonstrating fusion at 12 months post-operatively
Fusion is defined as the presence of bridging bone between adjacent endplates of the involved motion segment, AND ≤ 2º total angular motion from flexion to extension, AND < 1.25 mm translational motion.
Measured: 12 months

Secondary outcomes (9)

Scores on the Neck Disability Index Questionnaire
Measured: 12 months
Pain on the Visual Analog Scale
Measured: 12 months
Adverse Events
Serious device related adverse events.
Measured: 12 months
Score on the EQ-5D Health Outcomes Survey
Measured: 12 months
Disc Height in millimetres
Measured: 12 months
Device Migration in millimetres
Measured: 12 months
Device Subsidence in millimetres
Measured: 12 months
Score on the RAND 36 item questionnaire
Measured: 12 months
Proportion of patients with subsequent surgical intervention
Measured: 12 months

Timeline

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

Oct 2015Mar 2019

First posted26 Oct 2015 (estimated)
Study startOct 2015
Primary completionMar 2019
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intervertebral Disc DegenerationStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02586116
Sponsor's protocol ID: NC03
Status last verified: Jul 2020
First submitted: 16 Oct 2015
Last updated: 27 Jul 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Zhao Z, Jiang D, Ou Y, Tang K, Luo X, Quan Z. A hollow cylindrical nano-hydroxyapatite/polyamide composite strut for cervical reconstruction after cervical corpectomy. J Clin Neurosci. 2012 Apr;19(4):536-40. doi: 10.1016/j.jocn.2011.05.043. Epub 2012 Feb 3.
PubMed 22305868
Kim SC, Kang SW, Kim SH, Cho KH, Kim SH. Clinical and radiological outcomes of anterior cervical interbody fusion using hydroxyapatite spacer. J Korean Neurosurg Soc. 2009 Oct;46(4):300-4. doi: 10.3340/jkns.2009.46.4.300. Epub 2009 Oct 31.
PubMed 19893716
Ryken TC, Heary RF, Matz PG, Anderson PA, Groff MW, Holly LT, Kaiser MG, Mummaneni PV, Choudhri TF, Vresilovic EJ, Resnick DK; Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons. Techniques for cervical interbody grafting. J Neurosurg Spine. 2009 Aug;11(2):203-20. doi: 10.3171/2009.2.SPINE08723.
PubMed 19769500

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

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

All Intervertebral Disc Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Comparison of nanOss Cervical Interbody Fusion System to C-Plus Interbody Fusion Device With Autograft
ClinicalTrials.gov ID: NCT02586116
Acronym / sponsor ID: NC03
Conditions: Intervertebral Disc Degeneration
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: RTI SurgicalIndustry (pharma, biotech, devices)
Study start: Oct 2015 (actual)
Primary completion: Mar 2019 (actual)
Study completion: Mar 2019 (actual)
First posted: 26 Oct 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
nanOss	Active comparator	Device: nanOssnanOss Cervical IBF System with nanOss BA Bone Void Filler
C-Plus	Active comparator	Device: C-PlusC-Plus PEEK IBF Device with autograft

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Is at least 21 years of age and skeletally mature.
Must have cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one level in the cervical spine between C3 to T1.
Must have completed a minimum of six weeks of unsuccessful conservative, non- operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment
Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (AP/LAT/FLX/EXT X-rays \& a recent MRI)
Is willing and able to comply with all clinical investigation visits and procedures including screening treatment procedures, post-operative management, the follow-up schedule and completion of forms or questionnaires.

Key exclusion criteria (15 listed)

Requires fusion at more than one level
Has had prior fusion at the level to be treated.
Has a metabolic or systemic bone disorder.
Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease)
Has a systemic or local infection (active or latent)

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
nanOssAlso: nanOss Cervical IBF DevicenanOss Cervical Interbody Fusion Device with nanOss BA bone void filler.	Device	nanOss
C-PlusAlso: C-Plus PEEK IBF DeviceC-Plus PEEK IBF Device with autograft	Device	C-Plus

Primary outcome

Number of patients demonstrating fusion at 12 months post-operatively
Time frame: 12 months
Fusion is defined as the presence of bridging bone between adjacent endplates of the involved motion segment, AND ≤ 2º total angular motion from flexion to extension, AND < 1.25 mm translational motion.

9 secondary outcomes

Scores on the Neck Disability Index Questionnaire
Time frame: 12 months
Pain on the Visual Analog Scale
Time frame: 12 months
Adverse Events
Time frame: 12 months
Score on the EQ-5D Health Outcomes Survey
Time frame: 12 months
Disc Height in millimetres
Time frame: 12 months
Device Migration in millimetres
Time frame: 12 months
Device Subsidence in millimetres
Time frame: 12 months
Score on the RAND 36 item questionnaire
Time frame: 12 months
Proportion of patients with subsequent surgical intervention
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
Background: PubMed 22305868Zhao Z, Jiang D, Ou Y, Tang K, Luo X, Quan Z. A hollow cylindrical nano-hydroxyapatite/polyamide composite strut for cervical reconstruction after cervical corpectomy. J Clin Neurosci. 2012 Apr;19(4):536-40. doi: 10.1016/j.jocn.2011.05.043. Epub 2012 Feb 3.
Background: PubMed 19893716Kim SC, Kang SW, Kim SH, Cho KH, Kim SH. Clinical and radiological outcomes of anterior cervical interbody fusion using hydroxyapatite spacer. J Korean Neurosurg Soc. 2009 Oct;46(4):300-4. doi: 10.3340/jkns.2009.46.4.300. Epub 2009 Oct 31.
Background: PubMed 19769500Ryken TC, Heary RF, Matz PG, Anderson PA, Groff MW, Holly LT, Kaiser MG, Mummaneni PV, Choudhri TF, Vresilovic EJ, Resnick DK; Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons. Techniques for cervical interbody grafting. J Neurosurg Spine. 2009 Aug;11(2):203-20. doi: 10.3171/2009.2.SPINE08723.
Individual participant dataSharing planned: No

Related trials for Intervertebral Disc Degeneration

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical 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.

Dieter Peuskens, MD principal investigator

Ziekenhuis Oost-Limburg

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

Questions about this trial

What is this clinical trial studying?

A study testing nanOss and C-Plus in people with Intervertebral Disc Degeneration, run by RTI Surgical at 1 site in Belgium.

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 6 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of patients demonstrating fusion at 12 months post-operatively (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 NCT02586116, which also lists 3 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 27 Jul 2020.