Clinical trial NCT04547959: Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®
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
Overall status: COMPLETED
Phase: NA
Conditions: C-CURVE , Cervical Interbody Cage
Cervical Disc Disease
Cervical Discopathy
Keywords: cervical disc disease
cervical disc degeneration
C-CURVE , cervical interbody cage
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, non-comparative and interventional post market clinical follow-up
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fusion of the cervical interbody cage used
timeFrame: 24 months
Secondary outcomes:
measure: Fusion of the cervical interbody cage used
timeFrame: 6, 12 and 24 months
measure: Quality of life with modified SF-12
timeFrame: Preoperative, and 6, 12 and 24 months postoperative
measure: Satisfaction patient
timeFrame: 6, 12 and 24 months
measure: VAS (Pain)
timeFrame: Preoperative, and 6, 12 and 24 months postoperative
measure: NDI(Neck Disability Index)
timeFrame: Preoperative, and 6, 12 and 24 months postoperative
measure: Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only
timeFrame: Preoperative, and 6, 12 and 24 months postoperative
measure: Complications
timeFrame: peroperative and 6, 12 and 24 months postoperative
measure: Fusion of the cervical interbody cage used
timeFrame: 6 and 12 months postoperative
Other outcomes:
Locations:
city: Tournai
country: Belgium
facility: CH WAPI
city: Bayonne
country: France
facility: Clinique Belharra
city: Castelnau-le-Lez
country: France
facility: Clinique du Parc
city: La Rochelle
country: France
facility: Groupe Hospitalier La Rochelle-Re-Aunis
city: Lyon
country: France
facility: Centre de consultations spécialisées de la Sauvegarde
city: Lyon
country: France
facility: Centre Orthopédique Santy
city: Marseille
country: France
facility: Clinique Clairval
city: Saint-Jean
country: France
facility: Clinique de l'Union
city: Sainte-Foy-lès-Lyon
country: France
facility: Clinique Charcot
city: Tours
country: France
facility: CHRU Bretonneau
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.