Trial Outcomes & Findings for Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty (NCT NCT00931515)
NCT ID: NCT00931515
Last Updated: 2014-05-26
Results Overview
The comparison of results was based on the proportion of participants with improved outcomes. The primary efficacy variable was treatment success based on the following criteria: 1. Oswestry Disability Index score improved by at least 15 points 2. Device success 3. Neurological success 4. Absence of major complications 5. Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure.
COMPLETED
NA
30 participants
24 months
2014-05-26
Participant Flow
Subjects were enrolled from February 2009 to December 2010. Patients were recruited from the medical practices of the Investigators. Enrollment was stopped in December 2010 due to the slow enrollment rate. A total of 30 subjects participated in the study; the protocol was intended for 440 patients.
Two patients were enrolled in the study and received a patient identification number, but were never randomized to a treatment group and never implanted with the device. One patient decided not to participate prior to randomization. The second patient did not meet all inclusion/exclusion criteria.
Participant milestones
| Measure |
NuBac
The NUBAC® disc arthroplasty system.
|
ProDisc
The ProDisc® total disc replacement system.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
NuBac
The NUBAC® disc arthroplasty system.
|
ProDisc
The ProDisc® total disc replacement system.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
Baseline Characteristics
Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Baseline characteristics by cohort
| Measure |
NuBac
n=15 Participants
The NUBAC® disc arthroplasty system.
|
ProDisc
n=15 Participants
The ProDisc® total disc replacement system.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
42.05 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe comparison of results was based on the proportion of participants with improved outcomes. The primary efficacy variable was treatment success based on the following criteria: 1. Oswestry Disability Index score improved by at least 15 points 2. Device success 3. Neurological success 4. Absence of major complications 5. Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure.
Outcome measures
| Measure |
NuBac
n=13 Participants
The NUBAC® disc arthroplasty system.
|
ProDisc
n=10 Participants
The ProDisc® device total disc replacement system.
|
|---|---|---|
|
Participants With Improved Patient Function
|
7 participants
|
6 participants
|
Adverse Events
NuBac
ProDisc
Serious adverse events
| Measure |
NuBac
n=15 participants at risk
The NUBAC® disc arthroplasty system.
|
ProDisc
n=15 participants at risk
The ProDisc® device total disc replacement system.
|
|---|---|---|
|
Surgical and medical procedures
Device expulsion
|
20.0%
3/15 • Number of events 3 • 2 years
|
0.00%
0/15 • 2 years
|
Other adverse events
| Measure |
NuBac
n=15 participants at risk
The NUBAC® disc arthroplasty system.
|
ProDisc
n=15 participants at risk
The ProDisc® device total disc replacement system.
|
|---|---|---|
|
Surgical and medical procedures
Implant migration
|
13.3%
2/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Nervous system disorders
Back Pain
|
33.3%
5/15 • Number of events 5 • 2 years
|
60.0%
9/15 • Number of events 9 • 2 years
|
|
Nervous system disorders
Hip/Buttock pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
20.0%
3/15 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
26.7%
4/15 • Number of events 4 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
Nervous system disorders
Leg paresthesia
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
Surgical and medical procedures
Surgical site reaction
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Adjacent level complication
|
13.3%
2/15 • Number of events 2 • 2 years
|
26.7%
4/15 • Number of events 4 • 2 years
|
|
Surgical and medical procedures
Surgical treatment
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal complication
|
6.7%
1/15 • Number of events 1 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
Skin and subcutaneous tissue disorders
Neck Cyst
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
General disorders
Headache
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
General disorders
Alopecia
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
General disorders
Falling
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Pregnancy
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
Psychiatric disorders
Psychiatric
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Shoulder Surgery
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
|
Surgical and medical procedures
Hand Surgery
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
Additional Information
Director of Regulatory and Clinical Affairs
Pioneer Surgical Technology
Results disclosure agreements
- Principal investigator is a sponsor employee Research parties agree not to make any publications of results until notified in writing by Sponsor that study is complete and results published in peer-reviewed journal; however if not published within 18 months, Research parties may pursue publication of individual results. Research parties must submit communication to Sponsor for review/approval at least 30 days prior to submission. Sponsor can require the modification of the manuscript or delay of publication.
- Publication restrictions are in place
Restriction type: OTHER