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Completed

NCT Number: NCT04547959

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

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.

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Key information

Conditions

C-CURVE , Cervical Interbody Cage Cervical Disc Disease Cervical Discopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH WAPI, Tournai, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cervical interbody cage C-CURVE

Device

ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage

Primary outcomes

  1. Fusion of the cervical interbody cage used

    Time frame: 24 months

    Measures the bone fusion thanks to the CTscan

Secondary outcomes

  1. Fusion of the cervical interbody cage used

    Time frame: 6, 12 and 24 months

    Measures the bone fusion thanks to the Xrays

  2. Quality of life with modified SF-12

    Time frame: Preoperative, and 6, 12 and 24 months postoperative

    Score of the modified SF-12 (to 0 (better) to 100 (worst)

  3. Satisfaction patient

    Time frame: 6, 12 and 24 months

    Score of the PSI (scale: 1/2/3/4 ; 1: Better)

  4. VAS (Pain)

    Time frame: Preoperative, and 6, 12 and 24 months postoperative

    Score of the pain (to 0 (better) to 10 (worst)

  5. NDI(Neck Disability Index)

    Time frame: Preoperative, and 6, 12 and 24 months postoperative

    Score of the pain (to 0 (better) to 50 (worst)

  6. Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only

    Time frame: Preoperative, and 6, 12 and 24 months postoperative

    radiographic measurements

  7. Complications

    Time frame: peroperative and 6, 12 and 24 months postoperative

    All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported

  8. Fusion of the cervical interbody cage used

    Time frame: 6 and 12 months postoperative

    Measures the bone fusion thanks to the CTscan

Sponsors and collaborators

Lead sponsor

Medicrea International

Industry

Registry information

Official study title

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

Acronym: C-CURVE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2020
Registry last updated
Jan 13, 2025

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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