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

NCT02586116 | Completed

• 1 other identifier: NC03
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervertebral Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (9)

• Scores on the Neck Disability Index Questionnaire

  12 months

• Pain on the Visual Analog Scale

  12 months

• Adverse Events

  12 months

• Score on the EQ-5D Health Outcomes Survey

  12 months

• Disc Height in millimetres

  12 months

Study Arms (2)

nanOss

ACTIVE COMPARATOR

nanOss Cervical IBF System with nanOss BA Bone Void Filler

Device: nanOss

C-Plus

ACTIVE COMPARATOR

C-Plus PEEK IBF Device with autograft

Device: C-Plus

Interventions

nanOss DEVICE

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

Also known as: nanOss Cervical IBF Device

nanOss

C-Plus DEVICE

C-Plus PEEK IBF Device with autograft

Also known as: C-Plus PEEK IBF Device

C-Plus

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RTI Surgical: lead

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Related Publications (3)

• 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.

  PMID: 22305868 BACKGROUND

• 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.

  PMID: 19893716 BACKGROUND

• 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.

  PMID: 19769500 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dieter Peuskens, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 26, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)