PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.

NCT05489822 | Recruiting FDA Device

• 1 other identifier: TDII_2014-003_2.1_103
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.

Conditions

Degenerative Disc Disease (DDD); Instabilities; Trauma; Deformity

Keywords

NDI

Outcome Measures

Primary Outcomes (1)

• Change of Neck Disability Index (NDI) preoperative (pre-op) compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)

  The primary endpoint for this PMCF (Post-Market Clinical Follow-Up) study will be the PROM (Patient-reported Outcome Measurement) instrument Neck Disability Index (NDI). This questionnaire is scientifically accepted. \[1\] The aim is to show an improvement of the NDI in comparison pre-op to post-op (12 months follow-up (± 1 month)). The reference for the primary endpoint NDI is a 2008 publication by Hovard Vernon, "The Neck Disability Index: State-of-the-Art, 1991-2008." \[1\] This comparative overview is referenced several times in other publications and represents the SoTA.

  pre-op compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)

Secondary Outcomes (12)

• Documentation of Complications

  intra-op

• Documentation of Complications

  Hospital discharge

• Documentation of Complications

  3 month (± 1 month)

• Documentation of Complications

  12 months follow-up (± 1 month)

• Examination of clinical performance

  pre-op

Interventions

VERTICALE® Cervical System DEVICE

All measures and devices mentioned in the study protocol correspond to routine clinical practice with the exception of the following questionnaires: NDI (Neck Disability Index) NRS (Numerical Rating Scale) neck pain (cervical spine) and NRS arm pain mJOA (modified Japanese Orthopaedic Association) Score

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

Patients (minimum 18 years old) who undergo surgery with the VERTICALE® Cervical System due to one or a combination of the above mentioned indications and give their written consent to participate.

You may qualify if:

• Ability to read, understand and speak the local language fluently to ensure understanding of Informed consent and protocol specific investigations
• The surgical indication must be one or a combination of the following
• Degenerative disc disease (DDD)
• Instabilities
• Trauma
• Deformities
• Mono-, bi- and multisegmental restoration (occipital T3)
• Age: ≥ 18 years

You may not qualify if:

• Relative and absolute contraindications according to IFU (Instruction for Use):
• Under certain circumstances, implantation is prohibited or associated with substantial risks, even though there may be an indication for it.
• These include in particular:
• Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium).
• Active systemic infection or an infection localized to the site of the proposed implantation
• Any case in which the chosen implants would be too large or too small to achieve a successful result.
• Any patient for whom the use of the implant would conflict with anatomical structures.
• Missing bony structures, which would render solid anchoring of the implant impossible (e.g., in the case of fractures, tumors, or osteoporosis). In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.

Sponsors & Collaborators

• Silony Medical GmbH: lead

Study Sites (1)

University of Illinois Hospital and Health Sciences System - UI Health

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (2)

• Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.

  PMID: 18803999 BACKGROUND

• Kato S, Oshima Y, Oka H, Chikuda H, Takeshita Y, Miyoshi K, Kawamura N, Masuda K, Kunogi J, Okazaki R, Azuma S, Hara N, Tanaka S, Takeshita K. Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study. PLoS One. 2015 Apr 2;10(4):e0123022. doi: 10.1371/journal.pone.0123022. eCollection 2015.

  PMID: 25837285 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Wounds and Injuries; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ankit I. Mehta, MD

  University of Illinois Hospital and Health Sciences System - UI Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankit I. Mehta, MD

CONTACT

(847) 826-6280; ankitm@uic.edu

Ralf Klabunde

CONTACT

+49 711 7825 0; rklabunde@silony-medical.com

Study Design

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

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 5, 2022
• Study Start: January 13, 2023
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)