Prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after single level Lumbar Disc Arthoplasty

Not Applicable

Completed

• Conditions: Degenerative Disc Disease of the Lumbar Spine; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12608000394347
• Lead Sponsor: Stryker South Pacific

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) A greater than 6 month history of degenerative disc disease prior to surgery
2) A greater than 6 month history of conservative treatment prior to surgery
3) Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
4) Patients who are capable of, and have given informed consent to their participation in the study.

Exclusion Criteria

1) Patients with previous destabilising spinal surgery or prior spinal fusion
2) Patients with advanced spinal facet arthrosis
3) Pregnancy
4) Patients with a metal allergy
5) Patients with Spondylolisthesis
6) Patients with osteoporosis
7) patients with renal impairment
8) patients that have any other kind of metallic implants
9) Patients taking health supplements with Chrome or Cobalt
10) Metabolic disorders that may affect Chromium and Cobalt metabolism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Analyse serum chrome and cobalt blood chemistry[Pre-op, 12 months post-op];2. Compare the pathology results (chrome and cobalt levels) to activity results (patient questionnaires VAS, Oswestry and SF-12)[Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)]

Secondary Outcome Measures

Name	Time	Method
Quality of life patient outcomes (using SF-12 v2 assesment patient questionnaire)[Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)];Radiological outcomes (using Lumbar spine x-rays, Antero-Posterior/Lateral/Flexion/Extension as assesment tool for bone quality and position of implant)[Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)];Patient pain scores (using VAS and Oswestry assesment patient questionnaires)[Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)]