Trial Outcomes & Findings for Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study) (NCT NCT00637312)
NCT ID: NCT00637312
Last Updated: 2014-03-27
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
At 24-months
Results posted on
2014-03-27
Participant Flow
Participant milestones
| Measure |
Advent™ Cervical Disc
Cervical artificial disc replacement: Advent™ Cervical Disc
|
Standard Care - Control
Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
36
|
|
Overall Study
COMPLETED
|
30
|
19
|
|
Overall Study
NOT COMPLETED
|
42
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)
Baseline characteristics by cohort
| Measure |
Advent™ Cervical Disc
n=72 Participants
Cervical artificial disc replacement: Advent™ Cervical Disc
|
Standard Care - Control
n=36 Participants
Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
|
Total
n=108 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
|
72 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
36 participants
n=7 Participants
|
108 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 24-monthsPopulation: The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.
Outcome measures
Outcome data not reported
Adverse Events
Advent™ Cervical Disc
Serious events: 16 serious events
Other events: 58 other events
Deaths: 0 deaths
Standard Care - Control
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Advent™ Cervical Disc
n=72 participants at risk
Cervical artificial disc replacement: Advent™ Cervical Disc
|
Standard Care - Control
n=36 participants at risk
Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
|
|---|---|---|
|
Surgical and medical procedures
Medical device removal
|
22.2%
16/72 • Number of events 17 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
Other adverse events
| Measure |
Advent™ Cervical Disc
n=72 participants at risk
Cervical artificial disc replacement: Advent™ Cervical Disc
|
Standard Care - Control
n=36 participants at risk
Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
36.1%
26/72 • Number of events 26 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
22.2%
8/36 • Number of events 8 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.8%
20/72 • Number of events 20 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
27.8%
10/36 • Number of events 10 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Pseudoarthrosis
|
1.4%
1/72 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
11.1%
4/36 • Number of events 4 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.9%
5/72 • Number of events 5 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
13.9%
5/36 • Number of events 5 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
5.6%
2/36 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
4.2%
3/72 • Number of events 3 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
6/72 • Number of events 6 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Spinal fracture
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
12/72 • Number of events 12 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
11.1%
4/36 • Number of events 4 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Paraesthesia
|
6.9%
5/72 • Number of events 5 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
11.1%
4/36 • Number of events 4 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Headache
|
12.5%
9/72 • Number of events 9 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
11.1%
4/36 • Number of events 4 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Burning sensation
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Muscular weakness
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Nervous system disorder
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
5.6%
2/36 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
1.4%
1/72 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
General disorders
Pain
|
4.2%
3/72 • Number of events 3 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Infections and infestations
Herpes zoster
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Psychiatric disorders
Depression
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Psychiatric disorders
Anxiety postoperative
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Vascular disorders
Hypertension
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Vascular disorders
Haematoma
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
2.8%
2/72 • Number of events 2 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
0.00%
0/36 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/72 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
2.8%
1/36 • Number of events 1 • Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse events were collected at all routine and unscheduled follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within the first 12 months following completion of the study, any publication must be initiated as a multi-center publication in conjunction with other PIs in the study. After 12 months, each PI is able to publish their data, but must first submit the publication to the sponsor within 60 days prior to publication. The sponsor has the right to make reasonable requests to protect the rights and interests of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER