Trial Outcomes & Findings for Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System (NCT NCT01832818)

NCT ID: NCT01832818

Last Updated: 2019-02-15

Results Overview

The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: At 24 months
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	NuNec Cervical Disc Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Overall Study STARTED	14
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	NuNec Cervical Disc Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Overall Study Lost to Follow-up	6

Baseline Characteristics

Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

Baseline characteristics by cohort

Measure	NuNec Cervical Disc n=14 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Age, Continuous	44 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 24 months

The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.

Outcome measures

Measure	NuNec Cervical Disc n=8 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Neck Disability Index (NDI) Score Improvement of at Least 15 Points	28.4 units on a scale Standard Deviation 27.1

PRIMARY outcome

Timeframe: At 24 months

The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). A higher score would indicate that the patient had a worse outcome.

Outcome measures

Measure	NuNec Cervical Disc n=8 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain	2.97 units on a scale Standard Deviation 3.27

PRIMARY outcome

Timeframe: Up to 24 months

The number of serious adverse events have been recorded

Outcome measures

Measure	NuNec Cervical Disc n=8 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Serious Adverse Events Related to the Device	0 Participants

PRIMARY outcome

Timeframe: Up to 24 months

The failures or re-operations or supplemental fixation at the treated level

Outcome measures

Measure	NuNec Cervical Disc n=8 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Device Failures or Removals, Revisions, Re-operations	0 Participants

SECONDARY outcome

Timeframe: At 24 months

As assessed on patient questionnaire.

Outcome measures

Measure	NuNec Cervical Disc n=8 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Patient Satisfaction Unsatisfied	0 Participants
Patient Satisfaction Very Satisfied	3 Participants
Patient Satisfaction Satisfied	4 Participants
Patient Satisfaction Somewhat Satisfied	1 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Absence of device migration > 3mm; Absence of device subsidence > 3mm

Outcome measures

Measure	NuNec Cervical Disc n=8 Participants Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Absence of Device Migration or Subsidence	0 Participants

Adverse Events

NuNec Cervical Disc

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	NuNec Cervical Disc n=14 participants at risk Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months. NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Nervous system disorders neurological impairment	7.1% 1/14 • Number of events 1 • Adverse events were recorded over the 24 month follow-up period
Musculoskeletal and connective tissue disorders Dysphagia	7.1% 1/14 • Number of events 1 • Adverse events were recorded over the 24 month follow-up period
Musculoskeletal and connective tissue disorders Pain in L forearm	7.1% 1/14 • Number of events 1 • Adverse events were recorded over the 24 month follow-up period
Musculoskeletal and connective tissue disorders Hand Paranesthesia	7.1% 1/14 • Number of events 1 • Adverse events were recorded over the 24 month follow-up period
Musculoskeletal and connective tissue disorders Hyperesthesia	7.1% 1/14 • Number of events 1 • Adverse events were recorded over the 24 month follow-up period
Musculoskeletal and connective tissue disorders Limited shoulder movement	7.1% 1/14 • Number of events 1 • Adverse events were recorded over the 24 month follow-up period

Additional Information

Robin Waite

RTI Surgical

Phone: 386-418-8888

Email: rwaite@rtix.com

Results disclosure agreements

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