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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CURVE Titane | Experimental | According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical interbody cage C-CURVE | Device | ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fusion of the cervical interbody cage used | Measures the bone fusion thanks to the CTscan | 24 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH WAPI | Tournai | Belgium | ||||
| Clinique Belharra |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27200226 | Background | 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. | |
| 23015339 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 18, 2025 | |
| Reset | Oct 9, 2025 | |
| Release | Apr 9, 2026 |
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Prospective, multicenter, non-comparative and interventional post market clinical follow-up
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| 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 |
| 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 | 31240 | France |
| Clinique Charcot | Sainte-Foy-lès-Lyon | France |
| CHRU Bretonneau | Tours | France |
| 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. |
| 24061968 | 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. |
| 28458586 | 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. |
| 27642818 | 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. |
| 30962412 | 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. |
| 25955093 | 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. |
| 27554353 | 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. |
| 29384883 | 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. |
| 28283840 | 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. |
| 26280730 | 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. |
| Reset | May 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 18, 2025 | Oct 9, 2025 | |||
| Apr 9, 2026 | May 1, 2026 |