Trial Outcomes & Findings for Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease (NCT NCT00443547)

Results Overview

Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

Recruitment status

COMPLETED

Target enrollment

231 participants

Primary outcome timeframe

24 Months

Results posted on

2019-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	1-level Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Overall Study STARTED	89	88	48	6
Overall Study Evaluated at 12 Months	58	55	37	5
Overall Study COMPLETED	44	46	27	4
Overall Study NOT COMPLETED	45	42	21	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1-level n=89 Participants Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level n=88 Participants Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level n=48 Participants Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level n=6 Participants Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	Total n=231 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 10.58 • n=88 Participants • Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively.	50.3 years STANDARD_DEVIATION 9.6 • n=87 Participants • Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively.	55.8 years STANDARD_DEVIATION 11.4 • n=48 Participants • Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively.	56.4 years STANDARD_DEVIATION 12.1 • n=6 Participants • Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively.	50.8 years STANDARD_DEVIATION 12.1 • n=229 Participants • Age and Gender was not available for two (2) subjects. These subjects were treated at 1 and 2 Levels respectively.
Sex/Gender, Customized Female	43 Participants n=88 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	49 Participants n=87 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	29 Participants n=48 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	5 Participants n=6 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	126 Participants n=229 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations
Sex/Gender, Customized Male	45 Participants n=88 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	38 Participants n=87 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	19 Participants n=48 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	1 Participants n=6 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations	103 Participants n=229 Participants • Gender was not reported for 2 Subjects; 1 at Level 1 and 1 at Level 2. Number analyzed will differ from other reported populations
Region of Enrollment United States · United States	89 Participants n=89 Participants	88 Participants n=88 Participants	48 Participants n=48 Participants	6 Participants n=6 Participants	231 Participants n=231 Participants
BMI	29.3 kg/m^2 STANDARD_DEVIATION 6.0 • n=89 Participants	29.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=88 Participants	28.8 kg/m^2 STANDARD_DEVIATION 5.5 • n=48 Participants	35.9 kg/m^2 STANDARD_DEVIATION 13.9 • n=6 Participants	29.3 kg/m^2 STANDARD_DEVIATION 6.3 • n=231 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Number of subjects present for the 24 month visit

Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

Outcome measures

Outcome measures
Measure	1-level n=44 Participants Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level n=46 Participants Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level n=27 Participants Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level n=4 Participants Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Radiographic Fusion	66 percentage of subjects	46 percentage of subjects	37 percentage of subjects	75 percentage of subjects

PRIMARY outcome

Timeframe: 12 Months

Population: Number of subjects present for the 12 month visit

Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

Outcome measures

Outcome measures
Measure	1-level n=58 Participants Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level n=55 Participants Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level n=37 Participants Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level n=5 Participants Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Radiographic Fusion	48 percentage of subjects	25 percentage of subjects	27 percentage of subjects	20 percentage of subjects

SECONDARY outcome

Timeframe: 24 Months

Population: The Total Population enrolled and treated includes 89 (1-Level), 88 (2-Level), 48 (3-Level), and 6 (4-Level). With each outcome measure, the actual Overall Number of Participants Analyzed will vary based on the actual number of participants who completed the specific assessment at the specific timepoint.

Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst

Outcome measures

Outcome measures
Measure	1-level n=42 Participants Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level n=47 Participants Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level n=27 Participants Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level n=5 Participants Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score	27 units on a scale Standard Deviation 22	29 units on a scale Standard Deviation 21	24 units on a scale Standard Deviation 22	17 units on a scale Standard Deviation 16

Adverse Events

1-level

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

2-level

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

3-level

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

4-level

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1-level n=89 participants at risk Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level n=88 participants at risk Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level n=48 participants at risk Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level n=6 participants at risk Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Musculoskeletal and connective tissue disorders Non-Union	1.1% 1/89 • Number of events 1 • From enrollment through 24 months	0.00% 0/88 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Nervous system disorders Dysphagia	2.2% 2/89 • Number of events 2 • From enrollment through 24 months	0.00% 0/88 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Blood and lymphatic system disorders Hematoma	0.00% 0/89 • From enrollment through 24 months	1.1% 1/88 • Number of events 1 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months

Other adverse events

Other adverse events
Measure	1-level n=89 participants at risk Patients needing a single level cervical fusion with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	2-level n=88 participants at risk Patients needing cervical fusion at two consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	3-level n=48 participants at risk Patients needing cervical fusion at three consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)	4-level n=6 participants at risk Patients needing cervical fusion at four consecutive levels with Vectra-T Vectra-T: Patient will receive the Vectra-T plate (Sized 1 to 4 levels)
Blood and lymphatic system disorders Hematoma / Seroma	1.1% 1/89 • Number of events 1 • From enrollment through 24 months	2.3% 2/88 • Number of events 2 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Psychiatric disorders Neurological Deficit	2.2% 2/89 • Number of events 2 • From enrollment through 24 months	0.00% 0/88 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	16.7% 1/6 • Number of events 1 • From enrollment through 24 months
Nervous system disorders Dysphagia	4.5% 4/89 • Number of events 5 • From enrollment through 24 months	4.5% 4/88 • Number of events 4 • From enrollment through 24 months	4.2% 2/48 • Number of events 2 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Musculoskeletal and connective tissue disorders Non-Union	2.2% 2/89 • Number of events 2 • From enrollment through 24 months	3.4% 3/88 • Number of events 3 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Vascular disorders Stroke	0.00% 0/89 • From enrollment through 24 months	1.1% 1/88 • Number of events 1 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Nervous system disorders Seizure	1.1% 1/89 • Number of events 1 • From enrollment through 24 months	1.1% 1/88 • Number of events 1 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months
Nervous system disorders Numbness or Tingling	0.00% 0/89 • From enrollment through 24 months	1.1% 1/88 • Number of events 1 • From enrollment through 24 months	0.00% 0/48 • From enrollment through 24 months	33.3% 2/6 • Number of events 2 • From enrollment through 24 months
General disorders Other	4.5% 4/89 • Number of events 4 • From enrollment through 24 months	3.4% 3/88 • Number of events 3 • From enrollment through 24 months	6.2% 3/48 • Number of events 3 • From enrollment through 24 months	0.00% 0/6 • From enrollment through 24 months

Additional Information

Mark Lotito

DePuy Synthes Spine

Phone: 508-880-8045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60