Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT04547959
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-09', 'releaseDate': '2025-09-18'}], 'estimatedResultsFirstSubmitDate': '2025-09-18'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, multicenter, non-comparative and interventional post market clinical follow-up'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-07', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion of the cervical interbody cage used', 'timeFrame': '24 months', 'description': 'Measures the bone fusion thanks to the CTscan'}], 'secondaryOutcomes': [{'measure': 'Fusion of the cervical interbody cage used', 'timeFrame': '6, 12 and 24 months', 'description': 'Measures the bone fusion thanks to the Xrays'}, {'measure': 'Quality of life with modified SF-12', 'timeFrame': 'Preoperative, and 6, 12 and 24 months postoperative', 'description': 'Score of the modified SF-12 (to 0 (better) to 100 (worst)'}, {'measure': 'Satisfaction patient', 'timeFrame': '6, 12 and 24 months', 'description': 'Score of the PSI (scale: 1/2/3/4 ; 1: Better)'}, {'measure': 'VAS (Pain)', 'timeFrame': 'Preoperative, and 6, 12 and 24 months postoperative', 'description': 'Score of the pain (to 0 (better) to 10 (worst)'}, {'measure': 'NDI(Neck Disability Index)', 'timeFrame': 'Preoperative, and 6, 12 and 24 months postoperative', 'description': 'Score of the pain (to 0 (better) to 50 (worst)'}, {'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', 'description': 'radiographic measurements'}, {'measure': 'Complications', 'timeFrame': 'peroperative and 6, 12 and 24 months postoperative', 'description': 'All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported'}, {'measure': 'Fusion of the cervical interbody cage used', 'timeFrame': '6 and 12 months postoperative', 'description': 'Measures the bone fusion thanks to the CTscan'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical disc disease', 'cervical disc degeneration', 'C-CURVE , cervical interbody cage'], 'conditions': ['C-CURVE , Cervical Interbody Cage', 'Cervical Disc Disease', 'Cervical Discopathy']}, 'referencesModule': {'references': [{'pmid': '27200226', 'type': 'BACKGROUND', '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.'}, {'pmid': '23015339', 'type': 'BACKGROUND', '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.'}, {'pmid': '24061968', 'type': 'BACKGROUND', '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.'}, {'pmid': '28458586', 'type': 'BACKGROUND', '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.'}, {'pmid': '27642818', 'type': 'BACKGROUND', '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.'}, {'pmid': '30962412', 'type': 'BACKGROUND', '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.'}, {'pmid': '25955093', 'type': 'BACKGROUND', '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.'}, {'pmid': '27554353', 'type': 'BACKGROUND', '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.'}, {'pmid': '29384883', 'type': 'BACKGROUND', '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.'}, {'pmid': '28283840', 'type': 'BACKGROUND', '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.'}, {'pmid': '26280730', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient operated with C-CURVE TITANIUM (MEDICREA) for one or several levels (3 maximum)\n* Cage implanted with the bone graft "OSMOSYS" (MEDICREA) or an auto bone graft from patients\n* Patient ≥ 18 years\n* Patient affiliated to health care insurance (social security in France)\n* Patient who signed an informed consent form\n* Patient able and willing to complete a self-administered questionnaire\n* Patient able to understand protocol and the planning visit and willing to perform all of them\n* Patient with a pathology indicated in the instruction for use of the implant\n\nExclusion Criteria:\n\n* Patient with no preoperative data available (X-rays, questionnaires)\n* Hybrid installation or cervical additional fixation\n* Patient contraindicated for X-ray(s) and/or CT-Scan(s)\n* Patient with contraindications indicated in the instruction for use of the implant\n* 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).\n* Patient who declined to participate to the study or unable to give his consent Vulnerable population as explained in the protocol'}, 'identificationModule': {'nctId': 'NCT04547959', 'acronym': 'C-CURVE', 'briefTitle': 'Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicrea International'}, 'officialTitle': 'Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®', 'orgStudyIdInfo': {'id': 'MDT220112102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-CURVE Titane', 'description': 'According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used', 'interventionNames': ['Device: cervical interbody cage C-CURVE']}], 'interventions': [{'name': 'cervical interbody cage C-CURVE', 'type': 'DEVICE', 'description': 'ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage', 'armGroupLabels': ['C-CURVE Titane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tournai', 'country': 'Belgium', 'facility': 'CH WAPI', 'geoPoint': {'lat': 50.60715, 'lon': 3.38932}}, {'city': 'Bayonne', 'country': 'France', 'facility': 'Clinique Belharra', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Castelnau-le-Lez', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 43.63605, 'lon': 3.90137}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'Groupe Hospitalier La Rochelle-Re-Aunis', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre de consultations spécialisées de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Orthopédique Santy', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '31240', 'city': 'Saint-Jean', 'country': 'France', 'facility': "Clinique de l'Union", 'geoPoint': {'lat': 43.66519, 'lon': 1.50459}}, {'city': 'Sainte-Foy-lès-Lyon', 'country': 'France', 'facility': 'Clinique Charcot', 'geoPoint': {'lat': 45.73375, 'lon': 4.80259}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicrea International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-18', 'type': 'RELEASE'}, {'date': '2025-10-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Medicrea International'}}}}