The NanoStrand Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-18

Study Completion Date

2021-01-30

Brief Summary

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A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).

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Detailed Description

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PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion

Conditions

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Disc Degeneration;Cervical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NanoMetalene/PEEK

Group Type OTHER

Anterior cervical discectomy and fusion

Intervention Type PROCEDURE

primary, 2-level, contiguous

NanoMetalene/Allograft

Group Type OTHER

Anterior cervical discectomy and fusion

Intervention Type PROCEDURE

primary, 2-level, contiguous

Interventions

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Anterior cervical discectomy and fusion

primary, 2-level, contiguous

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cervical degenerative disc disease
* Requires primary spinal fusion from C3-C7
* Minimum of 6 weeks of non-operative treatment
* Signed informed consent form

Exclusion Criteria

* Uncontrolled type I or II diabetes mellitus
* Morbid obesity
* Documented history of alcohol or drug abuse
* Fever or leukocytosis
* Current systemic infection
* Active malignancy and/or current chemotherapy
* Known history of osteoporosis
* Prior fusion or total disc replacement at the operative level or an adjacent level
* Infection of the operative site
* Use of implants from other systems
* Pregnancy
* Participation in another research study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No