Plain English Summary
Background and study aims
Trabecular Metal™ is extensively used in many orthopaedic implants manufactured by the company Zimmer Spine (in hip replacements and knee replacements among other devices). Zimmer also has a wide range of Trabecular Metal™ spinal interbody fusion cages for the cervical as well as the lumbar spine. Manufactured entirely from Trabecular Metal™ material, the TM Ardis interbody device is intended for fusion at one or two connecting levels in the spine. This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the TM Ardis implant.
Who can participate?
Patients suffering from degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis who have six months failed conservative treatment.
What does the study involve?
Over a period of two years participants will be followed on a regular basis (3,6, 12 and 24 months) to assess clinical outcomes and radiological parameters. Patients will be asked to answer some quality of life questionnaires as well as pain scales.
What are the possible benefits and risks of participating?
There will be no supplementary benefits than the one patients receive when having such a surgery.
Where is the study run from?
Six European centers will be involved in five countries (Spain, Germany, Sweden, Belgium, United Kingdom). For UK the hospital involved is Frimley Park NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
There will be 1 year for recruitment and two years follow up. It is anticipated that recruitment in UK will begin by March 2014.
Who is funding the study?
Zimmer Spine (France)
Who is the main contact?
Dr Mark Thomas, FRCS in Frimley NHS Hospital
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CME2013-01S
Study information
Scientific title
A prospective, multi-center, post-market surveillance study to assess the clinical efficacy and fusion rates of the Zimmer®TM Ardis Interbody Fusion System
Acronym
TMARDIS
Study hypothesis
The goal of this study is to demonstrate that implant is effective in reducing patient disability, which will be assessed with the Oswestry Disability Index (ODI) questionnaire.
Ethics approval
1. Regional Ethical Review Board in Gothenburg (Regionala etikprövningsnämnden i Göteborg), Sweden, 12/11/2013
2. Ethics Committee of the State Medical Association Brandenburg (Landesärztekammer Brandenburg), Germany, 07/08/2013
3. NHS Research Ethics Committees, UK - submission pending
Study design
Multi-center prospective open post-market surveillance study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis
Intervention
Lumbar surgery: Over a period of two years participants will be followed on a regular basis (3, 6, 12 and 24 months) to assess clinical outcomes and radiological parameters. Patients will be asked to answer to quality of life questionnaires as well as pain scales.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Improvement in patient's Oswestry Disability Index (ODI) score after TM Ardis cage insertion. A 15-point ODI improvement is expected to claim success of the criterion. Measure will be assessed preoperatively at 3, 6, 12 and 24 months.
Secondary outcome measures
The occurrence of implant-related complications defined as subsidence, breakage, migration and retrieval. Except radiological tests, the outcomes will be measured with questionnaires in native language preoperatively at 3, 6, 12 and 24 months. Radiological parameters calculation will be assessed by an external company.
Overall trial start date
03/03/2014
Overall trial end date
31/05/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 years or over
2. Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
3. ODI over or equal to 40/100
4. Back pain over or equal to 4/10
5. Mono segmental lumbosacral disease fulfilling the prior conditions: only one level between L2 and S1
6. Skeletally mature patients
7. Six months failed conservative treatment
8. Gave written consent to take part in the study by signing patient informed consent form
9. Physically and mentally able to comply with the protocol, including ability to read and complete required forms and adhere to the follow-up requirements of the protocol
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 in total
Participant exclusion criteria
1. Prior surgical procedure at the index level using the desired operative approach
2. Severe degenerative lesions at more than one level of the lumbosacral spine
3. Morbid obesity (BMI ≥ 40)
4. Active local infection in or near the operative region
5. Active systemic infection and/or disease
6. Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
7. Known or suspected sensitivity to the implant materials
8. Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
9. Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs
10. Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
11. Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
12. Pregnant
13. Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities
14. Current vertebral metastatic tumors
15. Symptomatic cardiac disease
16. Severe congenital or acquired vertebral deformities
Recruitment start date
03/03/2014
Recruitment end date
29/10/2015
Locations
Countries of recruitment
Belgium, Germany, Spain, Sweden, United Kingdom
Trial participating centre
Frimley Park NHS Foundation Trust
Frimley
GU167UJ
United Kingdom
Funders
Funder type
Industry
Funder name
Zimmer Spine (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary