NanoFUSE® PL Gutter PMCF

Phase 4UnknownNCT03751943

NanoFUSE Biologics, LLC50 enrolled

Overview

This study is a Post Market Follow Up Study to compare the fusion rates between the NanoFUSE® Bioactive Matrix (75%) w/autograft (25%) and autogenous bone in posterolateral gutter spinal fusion.

NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis.) These defects may be surgically created osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine. This product provides a bone graft substitute that remodels into the recipient's skeletal system. Radiographic success will be the primary judgement of success. All patient's achieving fused or probably fused status will be judged as a success.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Disc Disease

Interventions

NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)DEVICE

NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Grade I or II (less than 50% slip f the cephalic vertebra compared to the caudal vertebra) degenerative spondylolisthesis at one or two contiguous levels between L1 and L5 * Lumbar spinal stenosis at the same levels of the degenerative spondylolisthesis producing radiculopathy or neurogenic claudication unresponsive to a minimum of 3 months of nonsurgical treatment, or such patients with worsening neurological condition * Patients who are medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix is consistent with product labeling * Patients who have consented for surgical treatment * Patients able to provide informed consent for the study and complete the questionnaires Exclusion Criteria: * Lytic spondylolisthesis * Non degenerative stenosis (example: tumor, trauma, epidural, lipomatosis) * Segmental kyphosis at the level of the spondylolisthesis * Rheumatoid arthritis * Active infection * On long term disability or workers compensation claim

Outcomes

Primary Outcomes

Radiographic Success

All patients achieving fused or probably fused status will be judged as successes at 12 months.

Time frame: 12 months

Secondary Outcomes

Overall patient success

Overall patient success will be based on all clinical and radiographic evaluation parameters and complications for the indication for use. Success criteria includes the following: * Presence of radiographic fusion as evidenced by identification of new bone mass * No hardware failure or screw blackout * Decreased level of pain (VAS) * Maintained or improved level of function (ODI) * Maintained or improved neurological status

Time frame: 12 months postoperatively

Central Contacts

Holly Cole

CONTACT

978-358-7307 hollycole@rqmis.com

John McGuire

CONTACT

978-358-7307 johnmcguire@rqmis.com

Data from ClinicalTrials.gov

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