Post-marketing surveillance of interbody cages used for anterior cervical discectomy with fusion (ACDF) treatment Surgery
Conditions
Interventions
The goal of anterior cervical interbody cages used in anterior cervical discectomy with fusion (ACDF) surgical procedures is to obtain a solid union between two or more vertebrae. The solid fusion usu
surgery (V2)
imm post op/discharge (V3)
4-6 weeks post-op (V4)
12 months post- op (V5)
24 months post-op (V6).
Total duration of observation: around 25 months depending on the date of the inclusion.
Sponsors
Spineart (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are scheduled for surgery: 1.1. At least one and up to 2 SCARLET® AC-T consecutive cages between C3 and C7 levels, OR 1.2. At least one and up to 3 TRYPTIK® CA/CC cages between C3 and C7 levels, OR 1.3. At least one and up to 3 TRYPTIK® MC cages between C3 and C7 levels 2. Patient willing and able to comply with follow-up schedule and fill out questionnaires Preoperative inclusion criteria (for Enrollment): Patients with the surgery completed with at least one of the devices mentioned above Patients with written voluntary informed consent signed
Exclusion criteria
Exclusion criteria: 1. Patients under 18 years of age 2. Patients in whom cervical/radicular pain could be attributable to a diagnosis other than a degenerative disease, spondylosis, or Tryptik® CA/CC trauma, as well 3. Patients with a contraindication listed in the IFU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate at the treated level and at the patient level post-operatively measured qualitatively on CT scans at 12 months post-operative and 24 months if the previous CT scan did not show a solid fusion at the treated level(s). In the case of pseudoarthrosis, bone scintigraphy may be performed at 12 or 24 months to confirm the fusion status, per the sites’ standard of care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Performance of the SCARLET® AC-T, Tryptik® CA/CC, and Tryptik® MC cages will be measured using the following: 1.1 The subsidence incidence at the treated levels on lateral cervical X-ray images at V4 (4-6 weeks PO), V5 (12M PO) and V6 (24M PO) 1.2 Adjacent segment disease (ASD) rate during the post-operative FU and the ASD requiring surgery rate 2. The clinical benefits of SCARLET® AC-T, Tryptik® CA/CC, and Tryptik® MC cages will be measured using the following: 2.1 A clinical and neurological assessment at the preoperative visit (V1), V3 (imm PO) and V4 (4-16 weeks), V5 (12M PO) and V6 (24M PO) 2.2 Patient Reported Outcomes (PRO): 2.2.1. Pain measured using the Visual Analog Scale (VAS arm and neck) self-reported questionnaire at the preoperative visit (V1), V4 (4-16 weeks PO), V5 (12M PO) and V6 (24M PO) 2.2.2. Functional capacity measured using the Neck Disability Index (NDI) self-reported questionnaire at the preoperative visit (V1), V4 (4-16 weeks PO), V5 (12M PO) and V6 (24M PO) 2.2.3. Patient satisfaction measured using a Patient Reported Outcome (PRO) questionnaire scaling from very satisfied to very unsatisfied at V5 (12M PO) and V6 (24M PO) 3. Safety of SCARLET® AC-T, Tryptik® CA/CC, and Tryptik® MC will be measured using the following: 3.1. The incidence and time to resolution of all ADEs (Adverse Device Effects), SADEs (Serious Adverse Device Effects), and USADEs (Unanticipated Serious Adverse Device Effects) including all surgical revisions measured using patient medical records throughout the study to the last Post-op follow-up 3.2. The rate of device deficiencies measured using patient medical records that might have led to a SADE 4. Performance and safety of SCARLET® AC-T, Tryptik® CA/CC, and Tryptik® MC’s instrumentation supporting the surgery measured using data reported in the Case Report Form at one timepoint. The surgeon needs to report four types of performance and safety issues when performing the surgery (preparation of implementation s | — |
Countries
France
Contacts
Public ContactDervilla Bermingham
Outcome results
None listed