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Trial registered on ANZCTR


Registration number
ACTRN12608000394347
Ethics application status
Approved
Date submitted
23/07/2008
Date registered
4/08/2008
Date last updated
23/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after single level Lumbar Disc Arthoplasty
Scientific title
Prospective consecutive multi-centre 12 month follow up of 50 patients undergoing single level Lumbar Disc Arthroplasty, assessing the change in Chrome and Cobalt metal ions over time
Secondary ID [1] 659 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Disease of the Lumbar Spine 3451 0
Condition category
Condition code
Musculoskeletal 3609 3609 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3222 0
Treatment: Devices
Comparator / control treatment
The results of this study will be compared to current literature. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4503 0
1. Analyse serum chrome and cobalt blood chemistry
Timepoint [1] 4503 0
Pre-op, 12 months post-op
Primary outcome [2] 4559 0
2. Compare the pathology results (chrome and cobalt levels) to activity results (patient questionnaires VAS, Oswestry and SF-12)
Timepoint [2] 4559 0
Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)
Secondary outcome [1] 7613 0
Quality of life patient outcomes (using SF-12 v2 assesment patient questionnaire)
Timepoint [1] 7613 0
Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)
Secondary outcome [2] 7614 0
Radiological outcomes (using Lumbar spine x-rays, Antero-Posterior/Lateral/Flexion/Extension as assesment tool for bone quality and position of implant)
Timepoint [2] 7614 0
Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)
Secondary outcome [3] 7615 0
Patient pain scores (using VAS and Oswestry assesment patient questionnaires)
Timepoint [3] 7615 0
Pre-op, post-op (6 weeks, 3 months, 6 months, 12 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3632 0
Commercial sector/Industry
Name [1] 3632 0
Stryker South Pacific
Address [1] 3632 0
8 Herbert Street
St Leonards NSW 2065
Country [1] 3632 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker South Pacific
Address
8 Herbert Street
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 3266 0
None
Name [1] 3266 0
Address [1] 3266 0
Country [1] 3266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5687 0
Greenslopes Private Hospital
Ethics committee address [1] 5687 0
Newdegate St
Greenslopes Qld 4120
Ethics committee country [1] 5687 0
Australia
Date submitted for ethics approval [1] 5687 0
Approval date [1] 5687 0
10/07/2008
Ethics approval number [1] 5687 0
08/17
Ethics committee name [2] 5728 0
Greenslopes Private Hospital
Ethics committee address [2] 5728 0
Newdegate Street
Greenslopes Qld 4120
Ethics committee country [2] 5728 0
Australia
Date submitted for ethics approval [2] 5728 0
Approval date [2] 5728 0
08/07/2008
Ethics approval number [2] 5728 0
08/17

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28773 0
Address 28773 0
Country 28773 0
Phone 28773 0
Fax 28773 0
Email 28773 0
Contact person for public queries
Name 11930 0
Dr Tim Barker
Address 11930 0
Director of Clinical Research, Stryker Australia, 8 Herbert Street, ST LEONARDS NSW 2065
Country 11930 0
Australia
Phone 11930 0
61 2 9467 1073
Fax 11930 0
61 2 9467 1132
Email 11930 0
tim.barker@stryker.com
Contact person for scientific queries
Name 2858 0
Dr Bruce Hall
Address 2858 0
Medical Centre, Greenslopes Private Hosptial, Newdegate Street, Greenslopes, QLD 4120
Country 2858 0
Australia
Phone 2858 0
61 7 3421 6000
Fax 2858 0
Email 2858 0
brucehall@qns.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary