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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Disc Disease; Cervical Discopathy; C-CURVE , Cervical Interbody Cage
• Intervention / Treatment: Device: cervical interbody cage C-CURVE

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Tournai, Belgium
    • CH Wapi
• France
  • Bayonne, France
    • Clinique Belharra
  • Castelnau-le-Lez, France
    • Clinique du Parc
  • La Rochelle, France
    • Groupe Hospitalier La Rochelle-Ré-Aunis
  • Lyon, France
    • Centre de consultations spécialisées de la Sauvegarde
  • Lyon, France
    • Centre Orthopedique Santy
  • Marseille, France
    • Clinique Clairval
  • Saint-Jean, France, 31240
    • Clinique de l'Union
  • Sainte-Foy-lès-Lyon, France
    • Clinique Charcot
  • Tours, France
    • CHRU Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-CURVE Titane; According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used	Device: cervical interbody cage C-CURVE; ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion of the cervical interbody cage used	Measures the bone fusion thanks to the CTscan	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion of the cervical interbody cage used	Measures the bone fusion thanks to the Xrays	6, 12 and 24 months
Quality of life with modified SF-12	Score of the modified SF-12 (to 0 (better) to 100 (worst)	Preoperative, and 6, 12 and 24 months postoperative
Satisfaction patient	Score of the PSI (scale: 1/2/3/4 ; 1: Better)	6, 12 and 24 months
VAS (Pain)	Score of the pain (to 0 (better) to 10 (worst)	Preoperative, and 6, 12 and 24 months postoperative
NDI(Neck Disability Index)	Score of the pain (to 0 (better) to 50 (worst)	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	radiographic measurements	Preoperative, and 6, 12 and 24 months postoperative
Complications	All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported	peroperative and 6, 12 and 24 months postoperative
Fusion of the cervical interbody cage used	Measures the bone fusion thanks to the CTscan	6 and 12 months postoperative

Collaborators and Investigators

• Sponsor: Medicrea International

Publications and helpful links

General Publications

• Alimi M, Njoku I, Hofstetter CP, Tsiouris AJ, Kesavabhotla K, Boockvar J, Navarro-Ramirez R, Hartl R. Anterior Cervical Discectomy and Fusion (ACDF): Comparison Between Zero Profile Implants and Anterior Cervical Plate and Spacer. Cureus. 2016 Apr 17;8(4):e573. doi: 10.7759/cureus.573.
• 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.
• Barbagallo GM, Romano D, Certo F, Milone P, Albanese V. Zero-P: a new zero-profile cage-plate device for single and multilevel ACDF. A single institution series with four years maximum follow-up and review of the literature on zero-profile devices. Eur Spine J. 2013 Nov;22 Suppl 6(Suppl 6):S868-78. doi: 10.1007/s00586-013-3005-0. Epub 2013 Sep 24.
• Bucci MN, Oh D, Cowan RS, Davis RJ, Jackson RJ, Tyndall DS, Nehls D. The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes. Med Devices (Auckl). 2017 Apr 18;10:61-69. doi: 10.2147/MDER.S127133. eCollection 2017.
• 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.
• 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.
• 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.
• 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.
• 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.
• Nambiar M, Phan K, Cunningham JE, Yang Y, Turner PL, Mobbs R. Locking stand-alone cages versus anterior plate constructs in single-level fusion for degenerative cervical disease: a systematic review and meta-analysis. Eur Spine J. 2017 Sep;26(9):2258-2266. doi: 10.1007/s00586-017-5015-9. Epub 2017 Mar 10.
• Scholz M, Schelfaut S, Pingel A, Schleicher P, Kandziora F. A cervical "zero-profile" cage with integrated angle-stable fixation: 24-months results. Acta Orthop Belg. 2014 Dec;80(4):558-66.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: cervical disc disease; cervical disc degeneration; C-CURVE , cervical interbody cage
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: MDT220112102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No