Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial

NCT01557829 | Completed DMC

• 2 other identifiers: Amedica 2011-9NL34808.100.10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Conditions

Disc Degeneration of Pfirrmann Grade III or Greater; Degenerative Spondylolisthesis; Isthmic Spondylolisthesis of Grade I or II

Keywords

spondylolisthesis; disc degeneration; lumbar interbody fusion; randomized controlled trial; ceramic interbody spacer

Outcome Measures

Primary Outcomes (1)

• Roland Morris Disability Questionnaire (RMDQ)

  The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared

  12 months post-op

Secondary Outcomes (2)

• Fusion status

  3 mo., 6 mo., 12 mo., 24 months

• Oswestry Disability Index (ODI)

  12 months post-op

Study Arms (2)

PEEK interbody cage

ACTIVE COMPARATOR

Posterior fusion with an interbody spacer (cage) made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is filled with local bone or bone harvested from the iliac crest.

Device: Posterior lumbar interbody fusion with a PEEK cage

Valeo OL ceramic cage

EXPERIMENTAL

Posterior fusion with the Valeo OL cage, a silicon nitride ceramic interbody spacer. The center area of the cage is filled with autograft local bone or bone harvested from the iliac crest.

Device: Posterior lumbar interbody fusion with a Valeo OL cage

Interventions

Posterior lumbar interbody fusion with a PEEK cage DEVICE

PEEK cage suitable for oblique placement in the lumbar spine

Also known as: Amedica Phantom Plus or Pioneer Bullet-Tip cage

PEEK interbody cage

Posterior lumbar interbody fusion with a Valeo OL cage DEVICE

Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.

Also known as: Valeo OL, silicon nitride ceramic

Valeo OL ceramic cage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients age 18-75 years
• Chronic low back pain unresponsive to at least six months of conservative care
• MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II

You may not qualify if:

• Osteoporosis
• Patients with prior failed fusion at the same level
• Degenerative scoliosis
• Degenerative spondylolisthesis greater than Grade II
• Pregnancy
• Psychiatric or mental disease
• Alcoholism (drinking more than 5 units per day)
• Active infection or prior infection at the surgical site
• Active cancer
• Insufficient language skills to complete questionnaires
• Participation in another study
• More than two symptomatic levels that need fusion

Sponsors & Collaborators

• Amedica Corporation: lead

Study Sites (2)

Medical Center Haaglanden

The Hague, 2501 CK, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

Related Publications (1)

• Kersten RF, van Gaalen SM, Arts MP, Roes KC, de Gast A, Corbin TP, Oner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord. 2014 Feb 25;15:57. doi: 10.1186/1471-2474-15-57.

  PMID: 24568365 DERIVED

MeSH Terms

Conditions

Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

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

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)