LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

LDR Spine USA

ClinicalTrials.gov Identifier:

NCT00389597

First received: October 18, 2006

Last updated: July 7, 2016

Last verified: July 2016

History of Changes

Results First Received: January 3, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Degenerative Disc Disease
Intervention:	Device: Cervical Artificial Disc

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One Level TDR Arm: 169 subjects randomized (5 not operated) One Level ACDF Arm: 87 subjects randomized (6 not operated) Two level TDR arm: 232 subjects randomized (7 not operated). Two Level ACDF Arm: 115 subjects randomized (10 not operated)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 level TDR enrolled 184 incl15 training cases (2 withdrew consent, 1 AE, 2 other). 1 level ACDF enrolled 87 with no training cases (4 withdrew consent, 2 other) for 245 randomized subjects. 2 level TDR enrolled 241 incl. 9 training cases (1 withdrew consent, 6 other); 2 Level ACDF enrolled 115 with no training cases (4 withdrew consent, 6 other)

Reporting Groups

	Description
1 Level TDR Arm	Cervical artificial disc (investigational device) at 1 level
1 Level ACDF Arm	1 level control procedure (ACDF)
2 Level TDR Arm	Cervical artificial disc (investigational device) at 2 levels
2 Level ACDF Arm	2 level control procedure (ACDF)

Participant Flow: Overall Study

	1 Level TDR Arm	1 Level ACDF Arm	2 Level TDR Arm	2 Level ACDF Arm
STARTED	164	81	225	105
24 mo	156	75	221	99
COMPLETED	156	75	221	99
NOT COMPLETED	8	6	4	6
Lost to Follow-up	8	6	4	6

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
1 Level TDR	No text entered.
1 Level ACDF	No text entered.
2 Level TDR	No text entered.
2 Level ACDF	No text entered.
Total	Total of all reporting groups

Baseline Measures

	1 Level TDR	1 Level ACDF	2 Level TDR	2 Level ACDF	Total
Number of Participants [units: participants]	164	81	225	105	575
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	161	80	222	101	564
>=65 years	3	1	3	4	11
Age [units: years] Mean (Standard Deviation)
<=18 years	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Between 18 and 65 years	43.8 (7.9)	42.9 (8.8)	45.4 (7.1)	45.8 (7.8)	44.3 (8.0)
>=65 years	65.0 (1.0)	66.0 (1.0)	65.5 (0.6)	66.0 (1)	65.7 (0.8)
Gender [units: participants]
Female	86	45	112	45	288
Male	78	36	113	60	287
Region of Enrollment [units: participants]
United States	164	81	225	105	575

Outcome Measures

1. Primary:

Composite Definition of Study Success [ Time Frame: 2 Years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The clinical site must submit to the Company, for review, any manuscripts, papers, summaries, abstracts, outlines or other media for publication at least 60 days before disclosure for the Company to review. The company has 30 days to review the proposed publication for any patentable subject matter or designated confidential information or confidential health information and by written notice to the site/PI identify such text so that the Company has time to file a patent application.

Results Point of Contact:

Name/Title: Noah Bartsch, VP, Clinical,Regulatory,Quality
Organization: LDR Spine
phone: 512-344-3319
e-mail: noah.bartsch@ldrspine.com

Publications of Results:

Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.

Hisey MS, Zigler JE, Jackson R, Nunley PD, Bae HW, Kim KD, Ohnmeiss DD. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up. Int J Spine Surg. 2016 Feb 26;10:10. doi: 10.14444/3010. eCollection 2016.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, Hoffman GA, Gaede SE, Danielson GO 3rd, Gordon C, Stone MB. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine. 2015 Jan;22(1):15-25. doi: 10.3171/2014.7.SPINE13953.

Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.

Responsible Party:	LDR Spine USA
ClinicalTrials.gov Identifier:	NCT00389597 History of Changes
Other Study ID Numbers:	LDR-001
Study First Received:	October 18, 2006
Results First Received:	January 3, 2014
Last Updated:	July 7, 2016
Health Authority:	United States: Food and Drug Administration

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