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Pedicle Osteotomy for Stenosis Trial

NCT03381677 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2020-08-03

No results posted yet for this study

Summary

This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.

Conditions

  • Lumbar Spinal Stenosis
  • Spondylolisthesis, Grade 1
  • Neurogenic Claudication

Interventions

DEVICE

Pedicle Lengthening Osteotomy with Altum® Device

Decompressive surgery via Pedicle lengthening osteotomy using Altum Device. Altum is intended for pedicle lengthening to correct degenerative lumbar spinal stenosis in the presence of a grade 1 degenerative spondylolisthesis. The Altum bone saw is designed for creating an osteotomy at the base of each pedicle. The Altum implant is designed for distraction of the pedicle osteotomy and for lengthening of the pedicles. Altum is appropriate for skeletally mature adults with symptomatic stenosis at one or two levels between L2-L5.

DEVICE

Control

Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) using either a midline or paramedian incision with implantation of bilateral pedicle screws (4 screws) and rods (2 rods) and an interbody fusion cage (1 PEEK fusion cage, coated or uncoated): 1. DePuy Synthes Expedium® 5.5 System, Stryker Xia 5.5 System, Medtronic CD Horizon Solera 5.5 Systemor Innovative Surgical Designs True Spinal Fixation System; and 2. DePuy Synthes Concord TLIF cage, Stryker UniLIF TLIF cage, Medtronic Capstone TLIF cage or Meditech Talos TLIF cage.

Sponsors & Collaborators

  • Innovative Surgical Designs

    lead INDUSTRY

Principal Investigators

  • Jon Rinehart · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2022-10-26
Completion
2024-10-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381677 on ClinicalTrials.gov