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

Primary Purpose

Intervertebral Disc Degeneration

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

nanOss

C-Plus

About this trial

This is an interventional treatment trial for Intervertebral Disc Degeneration

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
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.

Sites / Locations

Ziekenhuis Oost Limburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

nanOss

C-Plus

Arm Description

nanOss Cervical IBF System with nanOss BA Bone Void Filler

C-Plus PEEK IBF Device with autograft

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Scores on the Neck Disability Index Questionnaire

Pain on the Visual Analog Scale

Adverse Events

Serious device related adverse events.

Score on the EQ-5D Health Outcomes Survey

Disc Height in millimetres

Device Migration in millimetres

Device Subsidence in millimetres

Score on the RAND 36 item questionnaire

Proportion of patients with subsequent surgical intervention

Full Information

NCT ID

NCT02586116

First Posted

October 16, 2015

Last Updated

July 23, 2020

Sponsor

RTI Surgical

1. Study Identification

Unique Protocol Identification Number

NCT02586116

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

March 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RTI Surgical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intervertebral Disc Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nanOss

Arm Type

Active Comparator

Arm Description

nanOss Cervical IBF System with nanOss BA Bone Void Filler

Arm Title

C-Plus

Arm Type

Active Comparator

Arm Description

C-Plus PEEK IBF Device with autograft

Intervention Type

Device

Intervention Name(s)

nanOss

Other Intervention Name(s)

nanOss Cervical IBF Device

Intervention Description

nanOss Cervical Interbody Fusion Device with nanOss BA bone void filler.

Intervention Type

Device

Intervention Name(s)

C-Plus

Other Intervention Name(s)

C-Plus PEEK IBF Device

Intervention Description

C-Plus PEEK IBF Device with autograft

Primary Outcome Measure Information:

Title

Number of patients demonstrating fusion at 12 months post-operatively

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Scores on the Neck Disability Index Questionnaire

Time Frame

12 months

Title

Pain on the Visual Analog Scale

Time Frame

12 months

Title

Adverse Events

Description

Serious device related adverse events.

Time Frame

12 months

Title

Score on the EQ-5D Health Outcomes Survey

Time Frame

12 months

Title

Disc Height in millimetres

Time Frame

12 months

Title

Device Migration in millimetres

Time Frame

12 months

Title

Device Subsidence in millimetres

Time Frame

12 months

Title

Score on the RAND 36 item questionnaire

Time Frame

12 months

Title

Proportion of patients with subsequent surgical intervention

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dieter Peuskens, MD

Organizational Affiliation

Ziekenhuis Oost-Limburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ziekenhuis Oost Limburg

City

Genk

ZIP/Postal Code

3600

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22305868

Citation

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.

Results Reference

background

PubMed Identifier

19893716

Citation

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. Erratum In: J Korean Neurosurg Soc. 2009 Nov;46(5):511.

Results Reference

background

PubMed Identifier

19769500

Citation

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.

Results Reference

background

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

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