Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR)

NCT02967575 | Unknown

• 1 other identifier: CIP 16/01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic outcome information on patients suffering from intractable symptomatic cervical disc disease requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the Triadyme-C polycrystalline diamond compact cervical disc replacement.

Conditions

Intervertebral Disc Disorder Cervical

Keywords

cervical total disc replacement (cTDR)

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  Clinical outcome is measured by the Neck Disability Index (NDI) as published by Vernon et. al.. The primary endpoint of the study will be the mean total NDI at the 2 year postoperative assessment.

  2 years postoperative

Secondary Outcomes (6)

• Visual Analogue Scale (VAS) on neck pain

  2 years postoperative

• Visual Analogue Scale (VAS) on arm pain

  2 years postoperative

• Rate of device failure

  2 years postoperative

• Rate of subsequent surgical interventions

  2 years postoperative

• Range of motion at index level

  2 years postoperative

Other Outcomes (6)

• Adverse Events

  2 years postoperative

• Change in postoperative disc height at index level

  2 years postoperative

• Heterotopic ossification (HO) at index level

  2 years postoperative

Study Arms (1)

1- or 2-level cTDR

patients suffering from intractable symptomatic cervical disc disease (SCDD) requiring 1- or 2-level reconstruction of the disc from C3-C7

Device: cTDR

Interventions

cTDR DEVICE

The surgical procedure for the Triadyme-C total disc replacement corresponds to the standard surgical technique for cTDR: * Implantation through a standard anterior cervical approach * Midline identification * Routine discectomy with endplate preparation and decompression * Implant sizing and trial implantation * Keel preparation * Implant preparation and loading of the appropriate Triadyme-C implant * Triadyme-C insertion, positioned as close to the midline as possible

Also known as: cervical Total Disc Replacement

1- or 2-level cTDR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic of selected spine centers

You may qualify if:

• or 2-level cTDR surgery between C3 and C7
• Age ≥ 18 years
• Skeletally mature patient
• Patient suffers from intractable symptomatic cervical disc disease (SCDD) with neck or arm (radicular) pain and/or a functional/neurological deficit
• At least one of the following conditions must be present and confirmed by radiographic (CT, MRI, x-ray, etc.) studies: herniated nucleus pulposus, spondylosis (indicated by the presence of osteophytes), or loss of disc height.
• At least six weeks of non-operative treatment for SCDD has been tried and failed prior to implantation
• Psychosocially, mentally, and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
• Patient signed Informed Consent

You may not qualify if:

• Active systemic infection or infection localized to the site of implantation
• Allergy or sensitivity to the implant materials
• Osteoporosis, defined as a Dual-energy X-ray Absorptiometry (DXA) bone mineral density T-score equal to or less than -2.5
• Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments)
• Severe spondylosis characterized by bridging osteophytes or an absence of motion (less than 2 degrees)
• Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g. ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma)
• Significant kyphotic deformity or significant reversal of lordosis
• Previous cervical spinal surgery, other than discectomy at the levels to be operated on
• Use of any spinal implant other than Triadyme-C
• Adiposity, severe obesity (BMI \> 40 kg/m2)
• Patient who takes immunosuppressive or long-term steroid use
• Fever
• Systemic or metabolic illnesses (i.e. disease of bone-metabolism, insulin-dependent diabetes ...)
• Patient who is suffering from rheumatoid or other inflammatory joint disease
• Patient with any known active malignancy within the last 2 years

Sponsors & Collaborators

• Dymicron: lead

Study Sites (4)

Orth.med

Kümmersbruck, Bavaria, 92245, Germany

Location

STENUM Ortho GmbH

Ganderkesee, Lower Saxony, 27777, Germany

Location

Klinikum der Universität Rostock Abteilung für Neurochirurgie

Rostock, Mecklenburg-Vorpommern, 18055, Germany

Location

Charité Universitätsmedizin Berlin Klinik für Unfall- und Wiederherstellungschirurgie

Berlin, 12203, Germany

Location

Study Officials

• Jan Spiller, MD

  Stenum Ortho GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)