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

Cervical Disc Disease Clinical Trial

— C-CURVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04547959
• Other study ID #: MDT220112102
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: August 2023
• Source: Medicrea International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C-CURVE , Cervical Interbody Cage
• Cervical Disc Disease
• Cervical Discopathy
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement

Intervention

Device:
• cervical interbody cage C-CURVE
ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage

Locations

Country	Name	City	State
Belgium	CH WAPI	Tournai
France	Clinique Belharra	Bayonne
France	Clinique du Parc	Castelnau-le-Lez
France	Groupe Hospitalier La Rochelle-Re-Aunis	La Rochelle
France	Centre de consultations spécialisées de la Sauvegarde	Lyon
France	Centre Orthopédique Santy	Lyon
France	Clinique Clairval	Marseille
France	Clinique de l'Union	Saint-Jean
France	Clinique Charcot	Sainte-Foy-lès-Lyon
France	CHRU Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea International

Countries where clinical trial is conducted

Belgium,  France, 

References & 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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion of the cervical interbody cage used	Measures the bone fusion thanks to the CTscan	24 months
Secondary	Fusion of the cervical interbody cage used	Measures the bone fusion thanks to the Xrays	6, 12 and 24 months
Secondary	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
Secondary	Satisfaction patient	Score of the PSI (scale: 1/2/3/4 ; 1: Better)	6, 12 and 24 months
Secondary	VAS (Pain)	Score of the pain (to 0 (better) to 10 (worst)	Preoperative, and 6, 12 and 24 months postoperative
Secondary	NDI(Neck Disability Index)	Score of the pain (to 0 (better) to 50 (worst)	Preoperative, and 6, 12 and 24 months postoperative
Secondary	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
Secondary	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
Secondary	Fusion of the cervical interbody cage used	Measures the bone fusion thanks to the CTscan	6 and 12 months postoperative