Skip to main content
Clinical Trials/NCT04547959
NCT04547959CompletedNot Applicable

Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®

Medicrea International11 sites in 2 countries82 target enrollmentStarted: November 20, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
11
Primary Endpoint
Fusion of the cervical interbody cage used

Study Overview

Brief Summary

This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium.

The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.

This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient operated with C-CURVE TITANIUM (MEDICREA) for one or several levels (3 maximum)
  • Cage implanted with the bone graft "OSMOSYS" (MEDICREA) or an auto bone graft from patients
  • Patient ≥ 18 years
  • Patient affiliated to health care insurance (social security in France)
  • Patient who signed an informed consent form
  • Patient able and willing to complete a self-administered questionnaire
  • Patient able to understand protocol and the planning visit and willing to perform all of them
  • Patient with a pathology indicated in the instruction for use of the implant

Exclusion Criteria

  • Patient with no preoperative data available (X-rays, questionnaires)
  • Hybrid installation or cervical additional fixation
  • Patient contraindicated for X-ray(s) and/or CT-Scan(s)
  • Patient with contraindications indicated in the instruction for use of the implant
  • Patient judged as non-compliant by the investigator, not unable to come back for the follow-up visits (for example: patient living more than 100 km away).
  • Patient who declined to participate to the study or unable to give his consent Vulnerable population as explained in the protocol

Outcomes

Primary Outcomes

Fusion of the cervical interbody cage used

Time Frame: 24 months

Measures the bone fusion thanks to the CTscan

Secondary Outcomes

  • Quality of life with modified SF-12(Preoperative, and 6, 12 and 24 months postoperative)
  • Satisfaction patient(6, 12 and 24 months)
  • Fusion of the cervical interbody cage used(6 and 12 months postoperative)
  • NDI(Neck Disability Index)(Preoperative, and 6, 12 and 24 months postoperative)
  • Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only(Preoperative, and 6, 12 and 24 months postoperative)
  • Complications(peroperative and 6, 12 and 24 months postoperative)
  • VAS (Pain)(Preoperative, and 6, 12 and 24 months postoperative)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

Loading locations...

Similar Trials