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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389597
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : May 1, 2014
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
LDR Spine USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Degenerative Disc Disease
Intervention Device: Cervical Artificial Disc
Enrollment 599
Recruitment Details 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 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)
Arm/Group Title 1 Level TDR 1 Level ACDF 2 Level TDR 2 Level ACDF
Hide Arm/Group Description Cervical artificial disc (investigational device) at 1 level 1 level control procedure (ACDF) Cervical artificial disc (investigational device) at 2 levels 2 level control procedure (ACDF)
Period Title: Overall Study
Started 164 81 225 105
24 mo 156 75 221 99
Completed 156 75 221 99
Not Completed 8 6 4 6
Reason Not Completed
Lost to Follow-up             8             6             4             6
Arm/Group Title 1 Level TDR 1 Level ACDF 2 Level TDR 2 Level ACDF Total
Hide Arm/Group Description Cervical artificial disc (investigational device) at 1 level 1 level control procedure (ACDF) Cervical artificial disc (investigational device) at 2 levels 2 level control procedure (ACDF) Total of all reporting groups
Overall Number of Baseline Participants 164 81 225 105 575
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 81 participants 225 participants 105 participants 575 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
161
  98.2%
80
  98.8%
222
  98.7%
101
  96.2%
564
  98.1%
>=65 years
3
   1.8%
1
   1.2%
3
   1.3%
4
   3.8%
11
   1.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 81 participants 225 participants 105 participants 575 participants
Female
86
  52.4%
45
  55.6%
112
  49.8%
45
  42.9%
288
  50.1%
Male
78
  47.6%
36
  44.4%
113
  50.2%
60
  57.1%
287
  49.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 164 participants 81 participants 225 participants 105 participants 575 participants
164 81 225 105 575
1.Primary Outcome
Title Composite Definition of Study Success
Hide Description

An individual subject in either treatment group was considered a success if the following criteria were met at 24 months:

  • Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities.
  • No study failures due to secondary surgical interventions at the index level
  • Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
includes study failures, per protocol, that are carried forward for overall success
Arm/Group Title 1 Level ACDF 1 Level TDR 2 Level ACDF 2 Level TDR
Hide Arm/Group Description:
control procedure (ACDF) at one level
Cervical artificial disc (investigational device) at 1 level
Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
control procedure (ACDF) at two levels
Overall Number of Participants Analyzed 75 156 99 221
Measure Type: Number
Unit of Measure: percentage of subjects analyzed
65.3 73.7 37.4 69.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Level ACDF, 1 Level TDR
Comments 1 Level: Ho: pm-pc <=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc > -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method Farrington Manning
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2 Level ACDF, 2 Level TDR
Comments

2 Level: Ho: pm-pc <=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc > -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.

2 Level: Ho: pm-pc <= 0 (not superior) Alternative hypothesis: Ha: pm-pc >0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Farrington-Manning
Comments [Not Specified]
Time Frame 24 months
Adverse Event Reporting Description Adverse events are reported on all patients treated, including 24 surgical training subjects. Randomized total = 575, safety population total =599
 
Arm/Group Title 1 Level TDR Arm 1 Level ACDF Arm 2 Level TDR Arm 2 Level ACDF Arm
Hide Arm/Group Description Cervical artificial disc (investigational device) at 1 level [Not Specified] Cervical artificial disc (investigational device) at 2 levels [Not Specified]
All-Cause Mortality
1 Level TDR Arm 1 Level ACDF Arm 2 Level TDR Arm 2 Level ACDF Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
1 Level TDR Arm 1 Level ACDF Arm 2 Level TDR Arm 2 Level ACDF Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/179 (17.88%)      21/81 (25.93%)      56/234 (23.93%)      34/105 (32.38%)    
Cardiac disorders         
Cardiovascular  1  4/179 (2.23%)  4 1/81 (1.23%)  1 7/234 (2.99%)  9 1/105 (0.95%)  1
Gastrointestinal disorders         
Gastrointestinal  1  5/179 (2.79%)  8 1/81 (1.23%)  2 3/234 (1.28%)  3 2/105 (1.90%)  2
General disorders         
Death  1 [1]  0/179 (0.00%)  0 0/81 (0.00%)  0 1/234 (0.43%)  1 0/105 (0.00%)  0
Other  1 [2]  6/179 (3.35%)  8 1/81 (1.23%)  1 12/234 (5.13%)  14 9/105 (8.57%)  13
Infections and infestations         
Infection  1 [3]  3/179 (1.68%)  5 4/81 (4.94%)  6 6/234 (2.56%)  9 3/105 (2.86%)  4
Musculoskeletal and connective tissue disorders         
Heterotopic Ossification  1 [4]  1/179 (0.56%)  1 0/81 (0.00%)  0 0/234 (0.00%)  0 0/105 (0.00%)  0
Neck and/or Arm Pain  1 [5]  3/179 (1.68%)  4 2/81 (2.47%)  4 10/234 (4.27%)  15 6/105 (5.71%)  8
Non-union  1 [6]  0/179 (0.00%)  0 5/81 (6.17%)  5 1/234 (0.43%)  3 11/105 (10.48%)  14
Other pain  1 [7]  6/179 (3.35%)  7 4/81 (4.94%)  4 10/234 (4.27%)  15 3/105 (2.86%)  3
Spinal Disorder  1 [8]  3/179 (1.68%)  3 7/81 (8.64%)  8 4/234 (1.71%)  4 7/105 (6.67%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer  1 [9]  1/179 (0.56%)  2 1/81 (1.23%)  1 1/234 (0.43%)  1 0/105 (0.00%)  0
Nervous system disorders         
Neurological  1 [10]  5/179 (2.79%)  8 3/81 (3.70%)  4 5/234 (2.14%)  5 5/105 (4.76%)  5
Upper Extremity Nerve Entrapment  1 [11]  3/179 (1.68%)  3 1/81 (1.23%)  2 4/234 (1.71%)  5 0/105 (0.00%)  0
Renal and urinary disorders         
Urogenital  1  2/179 (1.12%)  3 0/81 (0.00%)  0 1/234 (0.43%)  1 1/105 (0.95%)  1
Respiratory, thoracic and mediastinal disorders         
Dysphagia/Dysphonia  1 [12]  0/179 (0.00%)  0 1/81 (1.23%)  2 2/234 (0.85%)  2 2/105 (1.90%)  2
Respiratory  1  2/179 (1.12%)  2 1/81 (1.23%)  1 3/234 (1.28%)  3 0/105 (0.00%)  0
Skin and subcutaneous tissue disorders         
Wound Issue - Non-infection  1 [13]  0/179 (0.00%)  0 2/81 (2.47%)  2 2/234 (0.85%)  2 3/105 (2.86%)  3
Social circumstances         
Trauma  1 [14]  4/179 (2.23%)  5 5/81 (6.17%)  8 7/234 (2.99%)  10 2/105 (1.90%) 
Surgical and medical procedures         
Anatomy/Technical Difficulty  1 [15]  1/179 (0.56%)  1 0/81 (0.00%)  0 1/234 (0.43%)  1 1/105 (0.95%)  1
Malpositioned implant  1 [16]  1/179 (0.56%)  1 1/81 (1.23%)  1 1/234 (0.43%)  1 0/105 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
includes all deaths not related to the device - respiratory, cardiac, etc
[2]
includes Blood/Lymphatic, Congenital/Genetic, Ear/Labyrinth, Endocrine, Eye, Immune, Metabolism/Nutrition, Musculoskeletal /CT, Benign Neoplasm, Nervous, Psychiatric, Repro, Skin, Vascular , Poisoning, Pregnancy, Social & surgical/Medical procedures
[3]
Infection includes Superficial Wound - Cervical, Deep Wound - Cervical, Other Wound - Non Study Surgery, both Systemic and Local
[4]
Heterotopic Ossification includes Cervical - Index Level, Cervical - Adjacent Level and Non Cervical
[5]
Neck and/or Arm Pain includes pain (and related pain terms) specific to neck (cervical spine) and arm pain (and related pain terms) specific to arm (spinal disorders are recorded elsewhere).
[6]
Non-Union includes non-union, cervical fusion failure, pseudoarthrosis, and pending non-unions as reported ; limited to study surgery related events of non-union.
[7]
Other Pain including Shoulder, Back, Torso, Lower Extremity, Headache, Other
[8]
Spinal Disorder including Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
[9]
All reported of AEs of cancer (malignancy or malignant tumor/neoplasm)
[10]
Neurological including Upper Extremity - Sensory, motor, reflex; Lower Extremity - Sensory, motor, reflex; Upper & Lower Extremity - Sensory, motor, reflex; neck, back, spinal cord disturbance; gait disturbance, non specific and other
[11]
including all reported AEs of Carpel Tunnel Syndrome and Cubital Tunnel Syndrome, including AEs directly attributed to Carpel Tunnel Syndrome or Cubital Tunnel Syndrome, as well as Carpal Tunnel surgery.
[12]
includes all reported AEs of Dysphagia and other terms consistent with "difficulty swallowing" and all reported AEs of Dysphonia and other terms consistent with "voice change and/or disruption".
[13]
including Hematoma, Hematoma Evacuation and CSF Leakage
[14]
includes falls, motor vehicle accidents, assault, injury, etc. This category includes both cervical and non-cervical AEs of Trauma.
[15]
Anatomy/Technical Difficulty includes Cervical - Study Surgery, Cervical - Non Study Surgery and Non Cervical
[16]
includes misplaced screw, subsidence, a sub optimal or undesired position, regardless of causality. This is not mutually exclusive to surgeon error or sub-optimal placement of the original implant configuration.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Level TDR Arm 1 Level ACDF Arm 2 Level TDR Arm 2 Level ACDF Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   170/179 (94.97%)      75/81 (92.59%)      209/234 (89.32%)      100/105 (95.24%)    
Cardiac disorders         
Cardiovascular  1  20/179 (11.17%)  26 10/81 (12.35%)  10 21/234 (8.97%)  29 10/105 (9.52%)  12
Gastrointestinal disorders         
Gastrointestinal  1  39/179 (21.79%)  60 15/81 (18.52%)  37 47/234 (20.09%)  97 32/105 (30.48%)  52
General disorders         
Death  1  0/179 (0.00%)  0 0/81 (0.00%)  0 1/234 (0.43%)  1 0/105 (0.00%)  0
Other  1  77/179 (43.02%)  114 33/81 (40.74%)  66 99/234 (42.31%)  189 58/105 (55.24%)  104
Infections and infestations         
Infection  1  33/179 (18.44%)  51 20/81 (24.69%)  28 56/234 (23.93%)  98 30/105 (28.57%)  50
Musculoskeletal and connective tissue disorders         
Heterotopic Ossification  1  9/179 (5.03%)  10 4/81 (4.94%)  4 6/234 (2.56%)  6 1/105 (0.95%)  1
Neck and/or Arm Pain  1  101/179 (56.42%)  212 47/81 (58.02%)  98 102/234 (43.59%)  167 63/105 (60.00%)  111
Non-Union  1  0/179 (0.00%)  0 4/81 (4.94%)  4 1/234 (0.43%)  3 13/105 (12.38%)  18
Other Pain  1  102/179 (56.98%)  226 47/81 (58.02%)  144 131/234 (55.98%)  267 64/105 (60.95%)  132
Spinal Disorder  1  6/179 (3.35%)  7 10/81 (12.35%)  12 13/234 (5.56%)  18 13/105 (12.38%)  20
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer  1  4/179 (2.23%)  5 1/81 (1.23%)  2 3/234 (1.28%)  3 1/105 (0.95%)  1
Nervous system disorders         
Neurological  1  121/179 (67.60%)  401 52/81 (64.20%)  215 124/234 (52.99%)  426 78/105 (74.29%)  278
Upper Extremity Nerve Entrapment  1  8/179 (4.47%)  9 4/81 (4.94%)  5 13/234 (5.56%)  16 6/105 (5.71%)  7
Renal and urinary disorders         
Urogenital  1  9/179 (5.03%)  11 9/81 (11.11%)  12 15/234 (6.41%)  23 10/105 (9.52%)  14
Respiratory, thoracic and mediastinal disorders         
Dysphagia/Dysphonia  1  20/179 (11.17%)  26 17/81 (20.99%)  20 39/234 (16.67%)  43 24/105 (22.86%)  27
Respiratory  1  6/179 (3.35%)  6 6/81 (7.41%)  8 19/234 (8.12%)  29 11/105 (10.48%)  12
Skin and subcutaneous tissue disorders         
Wound Issue -- Non-Infection  1  1/179 (0.56%)  1 3/81 (3.70%)  3 4/234 (1.71%)  4 3/105 (2.86%)  3
Social circumstances         
Trauma  1  47/179 (26.26%)  70 20/81 (24.69%)  38 52/234 (22.22%)  89 20/105 (19.05%)  36
Surgical and medical procedures         
Anatomy/Techical Difficulty  1  11/179 (6.15%)  12 2/81 (2.47%)  4 9/234 (3.85%)  9 5/105 (4.76%)  5
Malpositioned Implant  1  2/179 (1.12%)  2 1/81 (1.23%)  1 4/234 (1.71%)  4 0/105 (0.00%)  0
Vascular disorders         
Vascular Intraoperative  1  1/179 (0.56%)  1 0/81 (0.00%)  0 0/234 (0.00%)  0 1/105 (0.95%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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 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
Layout table for Results Point of Contact information
Name/Title: Noah Bartsch, VP, Clinical,Regulatory,Quality
Organization: LDR Spine
Phone: 512-344-3319
EMail: noah.bartsch@ldrspine.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT00389597    
Other Study ID Numbers: LDR-001
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: January 3, 2014
Results First Posted: May 1, 2014
Last Update Posted: December 11, 2017