Clinical trial NCT02429908: Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
Official 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Degenerative Disc Disease
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability.

Detailed description: This study is a post-market clinical follow-up (PMCF) study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012. The data collected from this study will serve the purpose of confirming safety and performance of the TM Ardis implant. The goal of this study is to demonstrate that implant is effective in reducing patient disability, which will be assessed with the ODI questionnaire.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years
* Degenerative disc disease DDD with up to Grade 1 spondylolisthesis or retrolis-thesis at the involved level. DDD is defined as discogenic back pain with degener-ation of the disc confirmed by history and radiographic studies.
* ODI 40 out of 100
* Back pain 4 out of 10
* Mono segmental or two level lumbosacral disease
* Skeletally mature patients
* Six months failed conservative treatment.
* Gave written consent to take part in the study by signing the Ethics Committee's approved Patient Informed Consent Form.
* 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 pro-tocol.

Exclusion Criteria:

* Prior surgical procedure at the index level(s) using the desired operative approach.
* Severe degenerative lesions at more than two level of the lumbosacral spine.
* Morbid obesity (BMI greater than or equal to 40).
* Active local infection in or near the operative region.
* Active systemic infection and/or disease.
* Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation.
* Known or suspected sensitivity to the implant materials.
* Endocrine or metabolic disorders known to affect osteogenesis (e.g.Paget's disease, renal osteodystrophy, hypothyroidism)
* Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs.
* 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)
* Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
* Pregnant.
* Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities.
* Current vertebral metastatic tumors.
* Symptomatic cardiac disease.
* Severe congenital or acquired vertebral deformities.

Primary outcomes:
measure: Improvement in ODI score
timeFrame: 24 months
Secondary outcomes:
measure: Safety - Adverse Events
timeFrame: 24 months
measure: Fusion rate - X-ray
timeFrame: 3, 6, 12 and 24 month
measure: Patient Outcomes - Mean EQ-5D
timeFrame: 24 months
measure: Modic changes - MRI
timeFrame: 12 and 24 months
measure: Numerical Rating Scale (NRS) for back and leg
timeFrame: 3 , 6, 12, and 24 months
measure: Zung self-rating depression scale score
timeFrame: 3, 6, 12, & 24 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Department Neurosurgery
city: Vernon
country: Canada
facility: Vernon Jubile Hospital
state: British Columbia
city: Montreal
country: Canada
facility: McGill University
city: Toronto
country: Canada
facility: Sunnybrook Regional Hospital
city: Rennes
country: France
facility: C.H.U. RENNES - Pontchaillou
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Schwedt/Oder
country: Germany
facility: Asklepios Kliniken GmbH - Auguststrasse
city: Troisdorf
country: Germany
facility: St. Josef Hospital Troisdorf
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital Department of Orthopedics, Spine Divison
Study officials:
affiliation: Zimmer Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References: