Pedicle Osteotomy for Stenosis Trial

NASuspendedINTERVENTIONAL
Enrollment

344

Participants

Timeline

Start Date

October 26, 2017

Primary Completion Date

October 26, 2022

Study Completion Date

October 26, 2024

Conditions
Lumbar Spinal StenosisSpondylolisthesis, Grade 1Neurogenic 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."

Trial Locations (1)

19010

Rothman Institute, Bryn Mawr

Sponsors
All Listed Sponsors
lead

Innovative Surgical Designs

INDUSTRY

NCT03381677 - Pedicle Osteotomy for Stenosis Trial | Biotech Hunter | Biotech Hunter