Condition category
Musculoskeletal Diseases
Date applied
19/12/2013
Date assigned
27/01/2014
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mark Thomas

ORCID ID

Contact details

Frimley Park NHS Foundation Trust
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

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 below 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

02/03/2017

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

03/03/2015

Locations

Countries of recruitment

Belgium, Germany, Spain, Sweden, United Kingdom

Trial participating centre

Frimley Park NHS Foundation Trust
Frimley
GU167UJ
United Kingdom

Sponsor information

Organisation

Zimmer Spine (France)

Sponsor details

23 Parvis des Chartrons
Bordeaux Cedex
33080
France

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes