Post-Market Surveillance Study of the TM Ardis Interbody Fusion System

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429908
• Other study ID #: CME2013-01S
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: September 14, 2018

Study information

• Verified date: March 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• TM-Ardis Interbody
The TM Ardis implant is a single device manufactured wholly from Trabecular Metal™ (porous tantalum) material, a highly porous, three-dimensional biomaterial designed for biologic fixation. is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2- S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis Department Neurosurgery	Aalst
Canada	McGill University	Montreal
Canada	Sunnybrook Regional Hospital	Toronto
Canada	Vernon Jubile Hospital	Vernon	British Columbia
France	C.H.U. RENNES - Pontchaillou	Rennes
Germany	Klinikum Dortmund gGmbH	Dortmund
Germany	Asklepios Kliniken GmbH - Auguststrasse	Schwedt/Oder
Germany	St. Josef Hospital Troisdorf	Troisdorf
Spain	Fundación Jiménez Díaz - Servicio de Cirugía Ortopédica y Traumatología -Avda. Reyes Católicos,	Madrid
Sweden	Sahlgrenska University Hospital Department of Orthopedics, Spine Divison	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in ODI score	mean change in score of the ODI from baseline to 24 months post surgery. A 15 point improvement in ODI score will be considered as a success.	24 months
Secondary	Safety - Adverse Events	All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/ incidence and time to re-operation/ incidence and time to re-vision	24 months
Secondary	Fusion rate - X-ray	will be assessed at 3, 6, 12 and 24 months with the following fusion criteria: No evidence of radiolucency surrounding more than 50% of device, translational motion <3 mm and angular motion <5°.	3, 6, 12 and 24 month
Secondary	Patient Outcomes - Mean EQ-5D		24 months
Secondary	Modic changes - MRI	Modic changes will be assessed by MRI	12 and 24 months
Secondary	Numerical Rating Scale (NRS) for back and leg	Patients will grade back and leg pain with a numeric scale 0 - 10	3 , 6, 12, and 24 months
Secondary	Zung self-rating depression scale score	Patients will complete a questionaire to assess depression.	3, 6, 12, & 24 months