None listed
Conditions
Brief summary
This study will follow 50 patients for 12 months who undergo Total Disc Replacement in their lumbar spine using the Stryker Flexicore intevertebral disc. The Stryker Flexicore intevertebral disc is a single unit, all metal device. Pre-operatively the patients will have a clinical examination, x-rays, blood test, and complete three patient questionnaires (VAS, SF-12 and Oswestry). The study follow up visits will be at 6 weeks, 3 months, 6 months and 12 months post-operatively. These visits involve standard follow up care x-rays and clinical examination, in addition there will be three questionairres (VAS, SF-12 and Oswestry) for the patient to complete, and a blood test at the 12 month visit. The study aims to compare the Chrome and Cobalt metal ions level in the patient's blood after 12 months as well as assess the patient's pain and activity level outcomes pot-op.
Interventions
Total Disc Replacement (TDR) is an alternative to Lumbar Fusion in the treatment of spinal degenerative disc disease. This study will follow a cohort of 50 patients for 12 months who undergo TDR using the Stryker Flexicore intevertebral disc. The Stryker Flexicore intevertebral disc is a single unit, all metal device comprised of superior and inferior baseplates articulating around a centrally located, stationary centre of rotation. Pre-operatively the patients will have a clinical examination,
Total Disc Replacement (TDR) is an alternative to Lumbar Fusion in the treatment of spinal degenerative disc disease. This study will follow a cohort of 50 patients for 12 months who undergo TDR using the Stryker Flexicore intevertebral disc. The Stryker Flexicore intevertebral disc is a single unit, all metal device comprised of superior and inferior baseplates articulating around a centrally located, stationary centre of rotation. Pre-operatively the patients will have a clinical examination, x-rays, blood test, and complete three patient questionnaires (VAS - Visual Analog Scale, SF-12 - Short-form 12 survery and Oswestry). The pre-operative study visit will take approximately 45 minutes - 1 hour to complete. The study follow up visits will be at 6 weeks, 3 months, 6 months and 12 months post-operatively. These visits involve standard follow up care x-rays and clinical examination, and three questionairres (VAS, SF-12 and Oswestry) for the patient to complete. At the 12 month visit there will also be a blood test . Each follow up visit will take approximately 45 minutes - 1 hour to complete.
Sponsors
Stryker South Pacific
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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
Outcome results
None listed