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Completed

NCT Number: NCT02926391

UNiD 3D VBR Register

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.

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Key information

Conditions

Spinal Cord Compression Bone Disease, Infectious Bone Diseases Bone Diseases, Infectious Bone Neoplasms Central Nervous System Diseases Infections Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Ossification of Posterior Longitudinal Ligament Ossification, Heterotopic Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Diseases Spinal Neoplasms Spondylosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Tours

Tours, France

About this study

Anterior cervical corpectomy with fusion (ACCF) has been demonstrated as a good alternative to anterior cervical discectomy and fusion (ACDF) to treat cervical spondylotic myelopathy (CSM). However, the use of vertebral body replacement (VBR) cages is technically demanding, especially to adjust the size of the cage to the defect without compromising the endplate integrity increasing the risk of subsidence. Beside recent studies advocating the interest of the shape, size and design of an implant to achieve fusion and stability in cervical spinal diseases indications, 3D printing offering rapid and patient-specific manufacturing has emerged over the past years. Several materials and technologies can be used and clinical and radiological data are still sparse.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Symptomatic degenerative spinal disease
  • Pseudarthrosis
  • Patients > 18 years
  • Patients who signed an Informed Consent Form

Exclusion criteria

  • 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

Treatment and study plan

UNiD 3D VBR

Device

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

Other names: Patient-specific corpectomy implants, Custom-made corpectomy implants

Primary outcomes

  1. Quantification and description of implant-related adverse events

    Time frame: 12 months

    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

Secondary outcomes

  1. Fusion status

    Time frame: 6, 12, 24 months

    Radiological assessment of bony fusion

  2. Length of surgery

    Time frame: During surgery

    Surgeon questionnaire will be used to quantify surgery's length

  3. Surgical metrics

    Time frame: During surgery

    Surgeon questionnaire will be used to describe the surgery

  4. Quality of life

    Time frame: preoperatively and 6,12, and 24 months postoperation

    mJOA: Modified Japanese Orthopaedic Association Score

  5. Quality of life

    Time frame: preoperatively and 6,12, and 24 months postoperation

    EMS: European Myelopathy Score

  6. Pain

    Time frame: preoperatively and 6,12, and 24 months postoperation

    Visual Analog Score

  7. Disability

    Time frame: preoperatively and 6,12, and 24 months postoperation

    Neck disability index

  8. Variation of radiological vertebral heights

    Time frame: 6,12, 24 months

    Xrays assessment of segmental height operated

  9. Variation of radiological vertebral angulation

    Time frame: 6,12, 24 months postoperativley

    Xrays assessment of C2C7 angle and corpectomy angles

Sponsors and collaborators

Lead sponsor

Medicrea International

Industry

Registry information

Official study title

Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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