Clinical outcome and fusion rates after surgery with TM Ardis interbody fusion system
| ISRCTN | ISRCTN89404187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89404187 |
| ClinicalTrials.gov number | NCT02429908 |
| Secondary identifying numbers | CME2013-01S |
- Submission date
- 19/12/2013
- Registration date
- 27/01/2014
- Last edited
- 14/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Frimley Park NHS Foundation Trust
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom
Study information
| Study design | Multi-center prospective open post-market surveillance study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | TMARDIS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 03/03/2014 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 in total |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/03/2014 |
| Date of final enrolment | 29/10/2015 |
Locations
Countries of recruitment
- Belgium
- England
- Germany
- Spain
- Sweden
- United Kingdom
Study participating centre
GU167UJ
United Kingdom
Sponsor information
Industry
23 Parvis des Chartrons
Bordeaux Cedex
33080
France
"ROR" |
https://ror.org/029j6tp05 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/04/2021: The following changes were made:
1. The NCT number has been added.
2. The trial phase has been added from the ClinicalTrials.gov record.
10/04/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/03/2015 to 29/10/2015.
2. The overall trial end date was changed from 02/03/2017 to 31/05/2018.
