Spine Research With Roentgen Stereophotogrammetric Analysis

NCT00493558 | Completed Phase 4

• 1 other identifier: CDHA018
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather information on the effectiveness of a new spine implant for patients who require spinal fusion surgery. Based on this information, we hope to create a standard of good performance, or benchmark, against which future studies on this spine implant can be compared. By creating this benchmark we hope to improve care for patients who require spinal fusion surgery.

Conditions

Spondylolisthesis; Degenerative Lumbar Disc Disease; Spinal Stenosis

Keywords

Roentgen Stereophotogrammetric Analysis; Trabecular Metal Posterior Lumbar Interbody Cage; Posterior Lumbar Interbody Fusion Cage; Posterior Lumbar spine fusion surgery

Outcome Measures

Primary Outcomes (1)

• Spinal fusion and the rate of fusion and maintenance of spinal alignment will be assessed

  6 weeks, 3, 6, 12, and 24months.

Secondary Outcomes (1)

• Subjective outcome questionnaires will be used to characterize the patient sample used for the study to allow for comparisons to other treatments for this condition in the future.

  3, 6, 12, 24 months

Interventions

Trabecular Metal Intervertebral Cage with RSA beads DEVICE

Roentgen Stereophotogrammetric Analysis beads will be inserted at time of implant of the Trabecular Metal Intervertebral Cage.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be at least 20 years of age
• Clinical and radiologic history of spondylolisthesis (no greater than grade 1)
• Spinal stenosis for which conservative treatment has failed
• Degenerative disc disease, characterized by one or more of the following:
• instability (defined as angular motion \> 5° and/or translation \> 4mm, based on Flex/Ext radiographs)
• osteophyte formation
• decreased disc height
• thickening of ligamentous tissue
• disc degeneration or herniation
• facet joint degeneration

You may not qualify if:

• Fusion at more than one level
• Non-fusion surgery at the involved level
• Previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
• Patients with a highly-communicable disease, inflammatory or auto-immune based joint disease
• Those with a history of endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
• Patients with a documented titanium or tantalum alloy allergy or intolerance
• Patients currently receiving active treatment for cancer or treatment with steroids such as cortisone
• Patients with significant medical history that, in the Investigator's opinion, would not make them a good study candidate

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Capital District Health Authority, QEII Health Sciences Centre,& Dalhousie University

Halifax, Nova Scotia, B3H-3A7, Canada

Location

MeSH Terms

Conditions

Spondylolisthesis; Spinal Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Wm Oxner, M.D.

  Capital District Health Authority, QEII Health Science Centre, & Dalhousie University, Halifax. Nova Scotia,Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

CA (1)