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

Not Applicable

Completed

• Conditions: Intervertebral Disc Degeneration
• Interventions: Device: nanOss; Device: C-Plus

• Registration Number: NCT02586116
• Lead Sponsor: RTI Surgical

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-26
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. Is at least 21 years of age and skeletally mature.
2. 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.
3. 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
4. Has pre-operative objective evidence of primary diagnosis confirmed by appropriate imaging studies (AP/LAT/FLX/EXT X-rays & a recent MRI)
5. 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.
6. Is able to understand and sign the informed consent document

Exclusion Criteria

1. Requires fusion at more than one level
2. Has had prior fusion at the level to be treated.
3. Has a metabolic or systemic bone disorder.
4. Has a disease that significantly inhibits bone healing (i.e., severe osteoporosis, osteomalacia, Paget's disease)
5. Has a systemic or local infection (active or latent)
6. Has acute or chronic infections in the surgical area (i.e., soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis)
7. chronic use of steroids, other than episodic use or inhaled corticosteroids
8. 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)
9. has a mental or physical condition that would limit the ability to comply with study requirements or would preclude accurate evaluation.
10. Is immunocompromised or being treated with immunosuppressive agents (including chemotherapy or radiation treatment).
11. has documented allergies to hydroxyapatite or porcine collagen, PEEK, titanium, titanium alloy or tantalum.
12. currently pregnant, or interested in becoming pregnant during the clinical investigation follow-up
13. is a smoker
14. is a prisoner
15. is currently involved in another drug or device clinical investigation that may confound the clinical investigation data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nanOss	nanOss	nanOss Cervical IBF System with nanOss BA Bone Void Filler
C-Plus	C-Plus	C-Plus PEEK IBF Device with autograft

Primary Outcome Measures

Name	Time	Method
Number of patients demonstrating fusion at 12 months post-operatively	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium