Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

March 31, 2024

Study Completion Date

March 31, 2024

Conditions
Lumbar Spinal StenosisSpondylolisthesisDegenerative Disc Disease
Interventions
DEVICE

Minuteman Fusion Implant

The Minuteman™ interspinous interlaminar fusion device consists of a central threaded portion that has a two-part wing plate hinged near its proximal end, with spikes on the extended distal end of the wing plate, and a multi-spiked end cap plate that is located at the distal end of the device and is retained and tightened in place with a locking hex nut. Compression between the spiked wing plate and the spiked end cap plate serves to fix the spinous processes in place and to facilitate fusion, together with bone graft fusion material placed within the device. The threaded external body has been designed to provide ease of distraction and insertion via a minimally invasive surgical procedure.

PROCEDURE

surgical decompression

Surgical decompression refers to the following operations Laminectomy, Foraminotomy, Discectomy or any other surgical procedure that the clinician feels is relevant for the decompression of lumbar spinal stenosis

Trial Locations (4)

TA1 5DA

Taunton & Somerset NHS Foundation Trust of Musgrove Park Hospital, Taunton

IP4 5PD

The Ipswich Hospital NHS Trust, Ipswich

LS14 6UH

Pain and Interventional Neuromodulation Research Group, Pain Management Dept, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds

DY1 2HQ

The Dudley Group NHS Foundation Trust, Russell Hall Hospital, Birmingham

All Listed Sponsors
collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

lead

Spinal Simplicity LLC

INDUSTRY

NCT01455805 - Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis | Biotech Hunter | Biotech Hunter