Trial Outcomes & Findings for Performance of the Hedrocel(R) Cervical Fusion Device (NCT NCT00758758)
NCT ID: NCT00758758
Last Updated: 2013-08-23
Results Overview
Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (\< 3mm translation; \< 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
231 participants
Primary outcome timeframe
12 Months
Results posted on
2013-08-23
Participant Flow
Subjects were recruited between December 1999 and March 2007 from the investigators medical clinics.
Participant milestones
| Measure |
Hedrocel 1 Level Without Plate
Hedrocel 1 level without plate
|
Hedrocel 1 Level With Plate
Hedrocel 1 level with plate
|
Hedrocel 2 Levels With Plate
Hedrocel 2 levels with plate
|
Autograft Only - Illiac Crest
Autograft only - illiac crest
|
Autograft 1 Level With Plate
Autograft 1 level plated
|
Allograft 1 Level With Plate
Allograft 1 level plated
|
Allograft 2 Levels With Plate
Allograft 2 levels with plate
|
Autograft 2 Levels With Plate
Autograft 2 levels with plate
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
74
|
53
|
6
|
3
|
50
|
31
|
0
|
|
Overall Study
COMPLETED
|
11
|
49
|
35
|
4
|
1
|
36
|
17
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
25
|
18
|
2
|
2
|
14
|
14
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance of the Hedrocel(R) Cervical Fusion Device
Baseline characteristics by cohort
| Measure |
Hedrocel 1 Level Without Plate
n=14 Participants
Hedrocel 1 level without plate
|
Hedrocel 1 Level With Plate
n=74 Participants
Hedrocel 1 level with plate
|
Hedrocel 2 Levels With Plate
n=53 Participants
Hedrocel 2 levels with plate
|
Autograft Only - Illiac Crest
n=6 Participants
Autograft only - Illiac crest
|
Autograft With Plate
n=3 Participants
Autograft with plate
|
Allograft With Plate
n=50 Participants
Allograft with plate
|
Autograft 2 Levels With Plate
Autograft 2 levels with plate
|
Allograft 2 Levels With Plate
n=31 Participants
Allograft 2 levels with plate
|
Total
n=231 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
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
—
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Age Categorical
Between 18 and 65 years
|
14 participants
n=5 Participants
|
74 participants
n=7 Participants
|
53 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
50 participants
n=10 Participants
|
—
|
31 participants
n=6 Participants
|
231 participants
n=6 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
—
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
|
Age Continuous
|
45.14 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
49.0 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
44.1 years
STANDARD_DEVIATION 6.8 • n=10 Participants
|
—
|
49.29 years
STANDARD_DEVIATION 8.4 • n=6 Participants
|
46.86 years
STANDARD_DEVIATION 7.5 • n=6 Participants
|
|
Gender
Female
|
3 participants
n=5 Participants
|
43 participants
n=7 Participants
|
28 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
25 participants
n=10 Participants
|
—
|
20 participants
n=6 Participants
|
121 participants
n=6 Participants
|
|
Gender
Male
|
11 participants
n=5 Participants
|
31 participants
n=7 Participants
|
25 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
25 participants
n=10 Participants
|
—
|
11 participants
n=6 Participants
|
110 participants
n=6 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
74 participants
n=7 Participants
|
53 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
50 participants
n=10 Participants
|
—
|
31 participants
n=6 Participants
|
231 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsSuccess was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (\< 3mm translation; \< 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months
Outcome measures
| Measure |
1 Level Hedrocel Without Plate
n=11 Participants
1 level Hedrocel with out plate
|
One Level Hedrocel With Plate
n=49 Participants
Hedrocel with a plate
|
Two Levels Plated Hedrocel
n=35 Participants
2 Levels Plated Hedrocel
|
Illiac Crest Autograft - no Plate
n=4 Participants
Iliac Crest Autograft
|
Plated Autograft
n=1 Participants
Plated Autograft
|
Plated Allograft
n=36 Participants
Plated Allograft
|
2 Levels Plated Autograft
2 Levels with plated Autograft
|
2 Levels With Plated Allograft
n=17 Participants
2 Levels with plated Allograft
|
|---|---|---|---|---|---|---|---|---|
|
Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)
|
5 participants
|
33 participants
|
28 participants
|
2 participants
|
1 participants
|
22 participants
|
—
|
15 participants
|
PRIMARY outcome
Timeframe: 12 MonthsThe Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability. NDI scoring: * 0 - 4 = No disability * 5 - 14 = Mild disability * 15 - 24 = Moderate disability * 25 - 34 = Severe disability * 35 or over = Complete disability
Outcome measures
| Measure |
1 Level Hedrocel Without Plate
n=11 Participants
1 level Hedrocel with out plate
|
One Level Hedrocel With Plate
n=52 Participants
Hedrocel with a plate
|
Two Levels Plated Hedrocel
n=39 Participants
2 Levels Plated Hedrocel
|
Illiac Crest Autograft - no Plate
n=4 Participants
Iliac Crest Autograft
|
Plated Autograft
n=1 Participants
Plated Autograft
|
Plated Allograft
n=40 Participants
Plated Allograft
|
2 Levels Plated Autograft
2 Levels with plated Autograft
|
2 Levels With Plated Allograft
n=20 Participants
2 Levels with plated Allograft
|
|---|---|---|---|---|---|---|---|---|
|
Neck Disability Index (NDI)
|
14.82 units on a scale
Standard Deviation 14.10
|
11.25 units on a scale
Standard Deviation 10.30
|
8.77 units on a scale
Standard Deviation 7.67
|
6.25 units on a scale
Standard Deviation 8.02
|
1 units on a scale
Standard Deviation 0
|
8.65 units on a scale
Standard Deviation 8.56
|
—
|
10 units on a scale
Standard Deviation 6.77
|
Adverse Events
Hedrocel 1 Level Without Plate
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Hedrocel 1 Level With Plate
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Hedrocel 2 Levels With Plate
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Autograft Only - Illiac Crest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autograft With Plate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Allograft With Plate
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Autograft 2 Levels With Plate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Allograft 2 Levels With Plate
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hedrocel 1 Level Without Plate
n=14 participants at risk
Hedrocel 1 level without plate
|
Hedrocel 1 Level With Plate
n=74 participants at risk
Hedrocel 1 level with plate
|
Hedrocel 2 Levels With Plate
n=53 participants at risk
Hedrocel 2 levels with plate
|
Autograft Only - Illiac Crest
n=6 participants at risk
Autograft only - Illiac crest
|
Autograft With Plate
n=3 participants at risk
Autograft with plate
|
Allograft With Plate
n=50 participants at risk
Allograft with plate
|
Autograft 2 Levels With Plate
Autograft 2 levels with plate
|
Allograft 2 Levels With Plate
n=31 participants at risk
Allograft 2 levels with plate
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/74
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Non-Fusion
|
7.1%
1/14 • Number of events 1
|
0.00%
0/74
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Nervous system disorders
Headache
|
0.00%
0/14
|
1.4%
1/74 • Number of events 1
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Radiculopathy
|
0.00%
0/14
|
1.4%
1/74 • Number of events 1
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Pain- Neck and shoulder
|
0.00%
0/14
|
0.00%
0/74
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
3.2%
1/31 • Number of events 1
|
Other adverse events
| Measure |
Hedrocel 1 Level Without Plate
n=14 participants at risk
Hedrocel 1 level without plate
|
Hedrocel 1 Level With Plate
n=74 participants at risk
Hedrocel 1 level with plate
|
Hedrocel 2 Levels With Plate
n=53 participants at risk
Hedrocel 2 levels with plate
|
Autograft Only - Illiac Crest
n=6 participants at risk
Autograft only - Illiac crest
|
Autograft With Plate
n=3 participants at risk
Autograft with plate
|
Allograft With Plate
n=50 participants at risk
Allograft with plate
|
Autograft 2 Levels With Plate
Autograft 2 levels with plate
|
Allograft 2 Levels With Plate
n=31 participants at risk
Allograft 2 levels with plate
|
|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Device Loosening
|
14.3%
2/14 • Number of events 2
|
0.00%
0/74
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • Number of events 1
|
4.1%
3/74 • Number of events 3
|
9.4%
5/53 • Number of events 5
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck and Shoulder pain
|
7.1%
1/14 • Number of events 1
|
4.1%
3/74 • Number of events 3
|
13.2%
7/53 • Number of events 7
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/50 • Number of events 2
|
—
0/0
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/14
|
1.4%
1/74 • Number of events 1
|
3.8%
2/53 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Cervical Disc Degeneration
|
0.00%
0/14
|
1.4%
1/74 • Number of events 1
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Radiculopathy
|
0.00%
0/14
|
2.7%
2/74 • Number of events 2
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint and muscle disorder
|
0.00%
0/14
|
2.7%
2/74 • Number of events 2
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Infections and infestations
Infection - Surgical
|
0.00%
0/14
|
1.4%
1/74 • Number of events 1
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Surgical and medical procedures
Device Malfunction
|
0.00%
0/14
|
1.4%
1/74 • Number of events 1
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Numbness and Tingling
|
0.00%
0/14
|
0.00%
0/74
|
3.8%
2/53 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Pain - Non-specific
|
0.00%
0/14
|
0.00%
0/74
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Surgical and medical procedures
Device Migration
|
0.00%
0/14
|
0.00%
0/74
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Pseudoarthrosis
|
0.00%
0/14
|
0.00%
0/74
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/50
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Dysphonia
|
0.00%
0/14
|
0.00%
0/74
|
1.9%
1/53 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
0.00%
0/14
|
0.00%
0/74
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
—
0/0
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Non-Fusion
|
0.00%
0/14
|
0.00%
0/74
|
0.00%
0/53
|
0.00%
0/6
|
0.00%
0/3
|
2.0%
1/50 • Number of events 1
|
—
0/0
|
0.00%
0/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60