Trial Outcomes & Findings for Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating (NCT NCT02104167)

NCT ID: NCT02104167

Last Updated: 2019-04-16

Results Overview

Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.

• Recruitment status: COMPLETED
• Target enrollment: 110 participants
• Primary outcome timeframe: 12 months or more after device implantation; mean follow up 20.7 months
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	Operated Subjects With ROI-C Device Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Overall Study STARTED	110
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating

Baseline characteristics by cohort

Measure	Operated Subjects With ROI-C Device n=110 Participants Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.9 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months or more after device implantation; mean follow up 20.7 months

Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.

Outcome measures

Measure	Operated Subjects With ROI-C Device n=110 Participants Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Percentage of Participants With Fusion	99.1 Percentage of Participants

SECONDARY outcome

Timeframe: 12 months (Last available visit) post surgery

Population: Operated Subjects

NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain.

Outcome measures

Measure	Operated Subjects With ROI-C Device n=110 Participants Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain NDI	19.0 Units on a Scale Interval 0.0 to 72.0
Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain VAS Neck	26.5 Units on a Scale Interval 0.0 to 100.0
Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain VAS Left Arm	15.3 Units on a Scale Interval 0.0 to 89.0
Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain VAS Right Arm	12.5 Units on a Scale Interval 0.0 to 100.0

Adverse Events

Operated Subjects With ROI-C Device

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Operated Subjects With ROI-C Device n=110 participants at risk Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Musculoskeletal and connective tissue disorders Pseudoarthrosis	0.91% 1/110 • Number of events 1 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Musculoskeletal and connective tissue disorders Cervical stenosis	0.91% 1/110 • Number of events 1 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.

Other adverse events

Measure	Operated Subjects With ROI-C Device n=110 participants at risk Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Musculoskeletal and connective tissue disorders Upper extremity pain/numbness	10.0% 11/110 • Number of events 16 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Musculoskeletal and connective tissue disorders Fall/Injury	9.1% 10/110 • Number of events 12 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Musculoskeletal and connective tissue disorders Lower back pain	5.5% 6/110 • Number of events 6 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Musculoskeletal and connective tissue disorders Neck Pain	6.4% 7/110 • Number of events 10 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Musculoskeletal and connective tissue disorders Shoulder injury	7.3% 8/110 • Number of events 9 • Date of surgery through last follow up visit, mean of 20.7 months Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.

Additional Information

Clinical Affairs

Zimmer Biomet

Phone: 303-501-8571

Email: tammy.stinson2@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place