The NanoStrand Clinical Study

SeaSpine

Status: Suspended

Conditions: Disc Degeneration;Cervical

Treatments: Procedure: Anterior cervical discectomy and fusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT03871400

SS-NM-1801

Details and patient eligibility

About

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).

Full description

PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

NanoMetalene/PEEK

Other group

Treatment:

Procedure: Anterior cervical discectomy and fusion

NanoMetalene/Allograft

Other group

Treatment:

Procedure: Anterior cervical discectomy and fusion