C-CURVE , Cervical Interbody CageC-CURVENCT04547959

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

A study testing cervical interbody cage C-CURVE in people with C-CURVE , Cervical Interbody Cage and Cervical Disc Disease, run by Medicrea International at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: C-CURVE , Cervical Interbody Cage, Cervical Disc Disease, Cervical Discopathy
What is being tested?: cervical interbody cage C-CURVE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 10 sitesin 2 countries
Study dates: 20 Nov 2020to 1 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

France9 sites

Clinique Belharra
Bayonne
Clinique du Parc
Castelnau-le-Lez
Groupe Hospitalier La Rochelle-Re-Aunis
La Rochelle
Centre de consultations spécialisées de la Sauvegarde
Lyon
Centre Orthopédique Santy
Lyon
Clinique Clairval
Marseille
Clinique de l'Union
Saint-Jean, 31240
Clinique Charcot
Sainte-Foy-lès-Lyon
CHRU Bretonneau
Tours

Other trials in France

Belgium1 site

CH WAPI
Tournai

Other trials in Belgium

About this study

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

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
Being tested: cervical interbody cage C-CURVE
Keywords: cervical disc disease, cervical disc degeneration, C-CURVE , cervical interbody cage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04547959
Study group	Role	What they receive
C-CURVE Titane	Experimental	According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used Receives: Device: cervical interbody cage C-CURVE

What is being measured

The primary outcome is the main question the study is designed to answer.

Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the CTscan
Measured: 24 months

Secondary outcomes (8)

Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the Xrays
Measured: 6, 12 and 24 months
Quality of life with modified SF-12
Score of the modified SF-12 (to 0 (better) to 100 (worst)
Measured: Preoperative, and 6, 12 and 24 months postoperative
Satisfaction patient
Score of the PSI (scale: 1/2/3/4 ; 1: Better)
Measured: 6, 12 and 24 months
VAS (Pain)
Score of the pain (to 0 (better) to 10 (worst)
Measured: Preoperative, and 6, 12 and 24 months postoperative
NDI(Neck Disability Index)
Score of the pain (to 0 (better) to 50 (worst)
Measured: 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
Measured: 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
Measured: peroperative and 6, 12 and 24 months postoperative
Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the CTscan
Measured: 6 and 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20201 Oct 2024

First posted14 Sep 2020
Study start20 Nov 2020
Primary completion1 Oct 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for C-CURVE , Cervical Interbody CageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, multicenter, non-comparative and interventional post market clinical follow-up
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04547959
Sponsor's protocol ID: MDT220112102
Acronym: C-CURVE
Status last verified: Jan 2025
First submitted: 7 Sep 2020
Last updated: 13 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27200226
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.
PubMed 23015339
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.
PubMed 24061968
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.
PubMed 28458586
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.
PubMed 27642818
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.
PubMed 30962412
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.
PubMed 25955093
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.
PubMed 27554353
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.
PubMed 29384883
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.
PubMed 28283840
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.
PubMed 26280730

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®
ClinicalTrials.gov ID: NCT04547959
Acronym / sponsor ID: C-CURVE / MDT220112102
Conditions: C-CURVE , Cervical Interbody Cage, Cervical Disc Disease, Cervical Discopathy
Keywords: cervical disc disease, cervical disc degeneration, C-CURVE , cervical interbody cage
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Medicrea InternationalIndustry (pharma, biotech, devices)
Study start: 20 Nov 2020 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 14 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, multicenter, non-comparative and interventional post market clinical follow-up

Arm	Type	Receives
C-CURVE Titane	Experimental	Device: cervical interbody cage C-CURVEAccording the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cervical interbody cage C-CURVEACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage	Device	C-CURVE Titane

Primary outcome

Fusion of the cervical interbody cage used
Time frame: 24 months
Measures the bone fusion thanks to the CTscan

8 secondary outcomes

Fusion of the cervical interbody cage used
Time frame: 6, 12 and 24 months
Quality of life with modified SF-12
Time frame: Preoperative, and 6, 12 and 24 months postoperative
Satisfaction patient
Time frame: 6, 12 and 24 months
VAS (Pain)
Time frame: Preoperative, and 6, 12 and 24 months postoperative
NDI(Neck Disability Index)
Time frame: 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
Time frame: Preoperative, and 6, 12 and 24 months postoperative
Complications
Time frame: peroperative and 6, 12 and 24 months postoperative
Fusion of the cervical interbody cage used
Time frame: 6 and 12 months postoperative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Background: PubMed 27200226Alimi 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.
Background: PubMed 23015339Azab 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.
Background: PubMed 24061968Barbagallo 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.
Background: PubMed 28458586Bucci 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.
Background: PubMed 27642818Chen 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.
Background: PubMed 30962412De 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.
Background: PubMed 25955093Lee 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.
Background: PubMed 27554353Li 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.
Background: PubMed 29384883Lu 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.
Background: PubMed 28283840Nambiar 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.
Background: PubMed 26280730Scholz 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing cervical interbody cage C-CURVE in people with C-CURVE , Cervical Interbody Cage and Cervical Disc Disease, run by Medicrea International at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion of the cervical interbody cage used (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547959, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.