NCT02926391

Brief Summary

Multicenter study allowing to include the first sixty patients implanted with a custom-made corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients implanted in thoracolumbar region. The main objective is to confirm feasibilty and safety of patient-specific implants for one or multi-level corpectomy and fusion. This study was approved in March 2016 allowing to include retrospectivley all patients since the first implantation in January 2015 and prospectively all patients after the approval.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

June 27, 2016

Last Update Submit

May 2, 2023

Conditions

Spinal Cord CompressionSpondylosisOssification of Posterior Longitudinal LigamentSpinal NeoplasmsBone Disease, Infectious

Outcome Measures

Primary Outcomes (1)

  • Quantification and description of implant-related adverse events

    To confirm the safety of the surgery with patient specfic implant (UNiD 3D VBR). To quantify and describe adverse events or revision surgeries occuring during follow-up

    12 months

Secondary Outcomes (9)

  • Fusion status

    6, 12, 24 months

  • Length of surgery

    During surgery

  • Surgical metrics

    During surgery

  • Quality of life

    preoperatively and 6,12, and 24 months postoperation

  • Quality of life

    preoperatively and 6,12, and 24 months postoperation

  • +4 more secondary outcomes

Study Arms (2)

Cervical

30 patients who need anterior cervical corpectomy and fusion with patient-specific implants (UNiD 3D VBR)

Device: UNiD 3D VBR

Thoraco-lumbar

30 patients who need anterior thoracolumbar corpectomy and fusion with patient-specific implants (UNiD 3D VBR)

Device: UNiD 3D VBR

Interventions

UNiD 3D VBRDEVICE

Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion

Also known as: Patient-specific corpectomy implants, Custom-made corpectomy implants
CervicalThoraco-lumbar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who need single or multilevel corpectomy and fusion and who received a patient specific implants UNiD 3D VBR

You may qualify if:

  • Patients who underwent a single or multilevel cervical or thoracolumbar coprectomy and implanted with a patient specific implant (UNiD 3D VBR) for the following indications:
  • Cervical region
  • Fracture / Trauma
  • Tumors
  • Cervical spondylotic myelopathy
  • Infection (Ex: Osteomyelitis)
  • Spinal instability
  • Symptomatic degenerative spinal disease
  • Inflammatory rheumatism.
  • Pseudarthrosis
  • Thoracolumbar region
  • Fracture / Trauma
  • Tumors
  • Infection (Ex: Osteomyelitis)
  • Spinal instability
  • +4 more criteria

You may not qualify if:

  • Patients who can't or doesn't want to sign an ICF
  • Patients unable to fill HRQOL questionnaires
  • Non-compliant paitents regarding follow-up or protocol
  • Pregnant patient or intended to be pregnant within the next 2 years
  • Sytemic or local infection
  • Allergy known or suspected to a componant
  • Patients presenting a contraindication as indicated in the instruction for use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

Spinal Cord CompressionSpondylosisOssification of Posterior Longitudinal LigamentSpinal NeoplasmsBone Diseases, Infectious

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord InjuriesWounds and InjuriesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesOssification, HeterotopicPathologic ProcessesPathological Conditions, Signs and SymptomsBone NeoplasmsNeoplasms by SiteNeoplasmsInfections

Study Officials

  • Jean-Edouard Loret, MD

    CHU Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

October 6, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)