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

NCT04547959 | Completed

• 1 other identifier: MDT220112102
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 10

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.

Conditions

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

Keywords

cervical disc disease; cervical disc degeneration; C-CURVE , cervical interbody cage

Outcome Measures

Primary Outcomes (1)

• Fusion of the cervical interbody cage used

  Measures the bone fusion thanks to the CTscan

  24 months

Secondary Outcomes (8)

• Fusion of the cervical interbody cage used

  6, 12 and 24 months

• Quality of life with modified SF-12

  Preoperative, and 6, 12 and 24 months postoperative

• Satisfaction patient

  6, 12 and 24 months

• VAS (Pain)

  Preoperative, and 6, 12 and 24 months postoperative

• NDI(Neck Disability Index)

  Preoperative, and 6, 12 and 24 months postoperative

Study Arms (1)

C-CURVE Titane

EXPERIMENTAL

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

Device: cervical interbody cage C-CURVE

Interventions

cervical interbody cage C-CURVE DEVICE

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

C-CURVE Titane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicrea International: lead

Study Sites (10)

CH WAPI

Tournai, Belgium

Location

Clinique Belharra

Bayonne, France

Location

Clinique du Parc

Castelnau-le-Lez, France

Location

Groupe Hospitalier La Rochelle-Re-Aunis

La Rochelle, France

Location

Centre de consultations spécialisées de la Sauvegarde

Lyon, France

Location

Centre Orthopédique Santy

Lyon, France

Location

Clinique Clairval

Marseille, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

Clinique Charcot

Sainte-Foy-lès-Lyon, France

Location

CHRU Bretonneau

Tours, France

Location

Related Publications (11)

• 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.

  PMID: 27200226 BACKGROUND

• 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.

  PMID: 23015339 BACKGROUND

• 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.

  PMID: 24061968 BACKGROUND

• 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.

  PMID: 28458586 BACKGROUND

• 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.

  PMID: 27642818 BACKGROUND

• 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.

  PMID: 30962412 BACKGROUND

• 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.

  PMID: 25955093 BACKGROUND

• 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.

  PMID: 27554353 BACKGROUND

• 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.

  PMID: 29384883 BACKGROUND

• 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.

  PMID: 28283840 BACKGROUND

• 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.

  PMID: 26280730 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, non-comparative and interventional post market clinical follow-up

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: November 20, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9); BE (1)