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

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
cervical interbody cage C-CURVE
Sponsored by
Medicrea International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for C-CURVE , Cervical Interbody Cage focused on measuring cervical disc disease, cervical disc degeneration, C-CURVE , cervical interbody cage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH WAPI
  • Clinique Belharra
  • Clinique du Parc
  • Groupe Hospitalier La Rochelle-Re-Aunis
  • Centre de consultations spécialisées de la Sauvegarde
  • Centre Orthopédique Santy
  • Clinique Clairval
  • Clinique de l'Union
  • Clinique Charcot
  • CHRU Bretonneau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-CURVE Titane

Arm Description

According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used

Outcomes

Primary Outcome Measures

Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the CTscan

Secondary Outcome Measures

Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the Xrays
Quality of life with modified SF-12
Score of the modified SF-12 (to 0 (better) to 100 (worst)
Satisfaction patient
Score of the PSI (scale: 1/2/3/4 ; 1: Better)
VAS (Pain)
Score of the pain (to 0 (better) to 10 (worst)
NDI(Neck Disability Index)
Score of the pain (to 0 (better) to 50 (worst)
Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only
radiographic measurements
Complications
All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported
Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the CTscan

Full Information

First Posted
September 7, 2020
Last Updated
August 23, 2023
Sponsor
Medicrea International
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1. Study Identification

Unique Protocol Identification Number
NCT04547959
Brief Title
Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®
Acronym
C-CURVE
Official Title
Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicrea International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C-CURVE , Cervical Interbody Cage, Cervical Disc Disease, Cervical Discopathy
Keywords
cervical disc disease, cervical disc degeneration, C-CURVE , cervical interbody cage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, non-comparative and interventional post market clinical follow-up
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C-CURVE Titane
Arm Type
Experimental
Arm Description
According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used
Intervention Type
Device
Intervention Name(s)
cervical interbody cage C-CURVE
Intervention Description
ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage
Primary Outcome Measure Information:
Title
Fusion of the cervical interbody cage used
Description
Measures the bone fusion thanks to the CTscan
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Fusion of the cervical interbody cage used
Description
Measures the bone fusion thanks to the Xrays
Time Frame
6, 12 and 24 months
Title
Quality of life with modified SF-12
Description
Score of the modified SF-12 (to 0 (better) to 100 (worst)
Time Frame
Preoperative, and 6, 12 and 24 months postoperative
Title
Satisfaction patient
Description
Score of the PSI (scale: 1/2/3/4 ; 1: Better)
Time Frame
6, 12 and 24 months
Title
VAS (Pain)
Description
Score of the pain (to 0 (better) to 10 (worst)
Time Frame
Preoperative, and 6, 12 and 24 months postoperative
Title
NDI(Neck Disability Index)
Description
Score of the pain (to 0 (better) to 50 (worst)
Time Frame
Preoperative, and 6, 12 and 24 months postoperative
Title
Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only
Description
radiographic measurements
Time Frame
Preoperative, and 6, 12 and 24 months postoperative
Title
Complications
Description
All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported
Time Frame
peroperative and 6, 12 and 24 months postoperative
Title
Fusion of the cervical interbody cage used
Description
Measures the bone fusion thanks to the CTscan
Time Frame
6 and 12 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CH WAPI
City
Tournai
Country
Belgium
Facility Name
Clinique Belharra
City
Bayonne
Country
France
Facility Name
Clinique du Parc
City
Castelnau-le-Lez
Country
France
Facility Name
Groupe Hospitalier La Rochelle-Re-Aunis
City
La Rochelle
Country
France
Facility Name
Centre de consultations spécialisées de la Sauvegarde
City
Lyon
Country
France
Facility Name
Centre Orthopédique Santy
City
Lyon
Country
France
Facility Name
Clinique Clairval
City
Marseille
Country
France
Facility Name
Clinique de l'Union
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Clinique Charcot
City
Sainte-Foy-lès-Lyon
Country
France
Facility Name
CHRU Bretonneau
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27200226
Citation
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Results Reference
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PubMed Identifier
23015339
Citation
Azab W, Abdel-Razek M, Ali A, Abdelrahman A, Salaheldin W, Nasim K, Attia H, Soliman D. Outcome evaluation of a zero-profile implant for anterior cervical diskectomy with fusion. Turk Neurosurg. 2012;22(5):611-7. doi: 10.5137/1019-5149.JTN.5646-11.2.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
28458586
Citation
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Results Reference
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PubMed Identifier
27642818
Citation
Chen Y, Liu Y, Chen H, Cao P, Yuan W. Comparison of Curvature Between the Zero-P Spacer and Traditional Cage and Plate After 3-Level Anterior Cervical Discectomy and Fusion: Mid-term Results. Clin Spine Surg. 2017 Oct;30(8):E1111-E1116. doi: 10.1097/BSD.0000000000000440.
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PubMed Identifier
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Citation
De Leo-Vargas RA, Munoz-Romero I, Mondragon-Soto MG, Martinez-Anda JJ. Locking Stand-Alone Cage Constructs for the Treatment of Cervical Spine Degenerative Disease. Asian Spine J. 2019 Apr 10;13(4):630-637. doi: 10.31616/asj.2018.0234. Print 2019 Aug.
Results Reference
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PubMed Identifier
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Citation
Lee YS, Kim YB, Park SW. Does a zero-profile anchored cage offer additional stabilization as anterior cervical plate? Spine (Phila Pa 1976). 2015 May 15;40(10):E563-70. doi: 10.1097/BRS.0000000000000864.
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PubMed Identifier
27554353
Citation
Li Z, Zhao Y, Tang J, Ren D, Guo J, Wang H, Li L, Hou S. A comparison of a new zero-profile, stand-alone Fidji cervical cage and anterior cervical plate for single and multilevel ACDF: a minimum 2-year follow-up study. Eur Spine J. 2017 Apr;26(4):1129-1139. doi: 10.1007/s00586-016-4739-2. Epub 2016 Aug 23.
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PubMed Identifier
29384883
Citation
Lu Y, Bao W, Wang Z, Zhou F, Zou J, Jiang W, Yang H, Zhang Z, Zhu X. Comparison of the clinical effects of zero-profile anchored spacer (ROI-C) and conventional cage-plate construct for the treatment of noncontiguous bilevel of cervical degenerative disc disease (CDDD): A minimum 2-year follow-up. Medicine (Baltimore). 2018 Feb;97(5):e9808. doi: 10.1097/MD.0000000000009808.
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PubMed Identifier
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Citation
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Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®

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