Trial Outcomes & Findings for Cervical Spondylotic Myelopathy Surgical Trial (NCT NCT02076113)
NCT ID: NCT02076113
Last Updated: 2025-08-19
Results Overview
Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
269 participants
Primary outcome timeframe
1 year and 2 year
Results posted on
2025-08-19
Participant Flow
Participants were recruited between April 1, 2014 and March 30, 2018 from 15 study sites.
269 participants were eligible and enrolled; 163 randomized for treatment and 91 enrolled in a non-randomized cohort because either 80% or greater of review panel selected one surgical approach over the other (76), the participant did not consent to randomization (13), or at least 50% of review panel did not favor randomization (equipoise). 15 withdrew prior to randomization. Primary analysis compared ventral surgical approach to dorsal surgical approach.
Participant milestones
| Measure |
Ventral
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
100
|
|
Overall Study
Surgery as Randomized
|
62
|
96
|
|
Overall Study
3-Month Follow-up
|
56
|
90
|
|
Overall Study
6-Month Follow-up
|
53
|
91
|
|
Overall Study
1-Year Follow-up
|
60
|
95
|
|
Overall Study
2-Year Follow-up
|
51
|
79
|
|
Overall Study
COMPLETED
|
56
|
93
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Ventral
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Death
|
1
|
3
|
Baseline Characteristics
63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
Baseline characteristics by cohort
| Measure |
Ventral
n=63 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=100 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
SF-36 physical component score
|
37.4 units on a scale
STANDARD_DEVIATION 8.8 • n=63 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 9.9 • n=100 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 9.5 • n=163 Participants
|
|
mJOA scale score
|
12.2 units on a scale
STANDARD_DEVIATION 2.7 • n=63 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 2.2 • n=100 Participants
|
12.2 units on a scale
STANDARD_DEVIATION 2.4 • n=163 Participants
|
|
EQ-5D score
|
0.64 units on a scale
STANDARD_DEVIATION 0.21 • n=63 Participants
|
0.61 units on a scale
STANDARD_DEVIATION 0.21 • n=100 Participants
|
0.62 units on a scale
STANDARD_DEVIATION 0.21 • n=163 Participants
|
|
EQ-5D visual analog scale score
|
61.7 units on a scale
STANDARD_DEVIATION 20.9 • n=63 Participants
|
63.1 units on a scale
STANDARD_DEVIATION 21.7 • n=100 Participants
|
62.5 units on a scale
STANDARD_DEVIATION 21.3 • n=163 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 7.2 • n=63 Participants
|
62.5 years
STANDARD_DEVIATION 8.8 • n=100 Participants
|
62.3 years
STANDARD_DEVIATION 8.2 • n=163 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=63 Participants
|
51 Participants
n=100 Participants
|
80 Participants
n=163 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=63 Participants
|
49 Participants
n=100 Participants
|
83 Participants
n=163 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=63 Participants
|
4 Participants
n=100 Participants
|
6 Participants
n=163 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=63 Participants
|
96 Participants
n=100 Participants
|
157 Participants
n=163 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=63 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=163 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=63 Participants
|
3 Participants
n=100 Participants
|
4 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=63 Participants
|
3 Participants
n=100 Participants
|
5 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=63 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=63 Participants
|
7 Participants
n=100 Participants
|
13 Participants
n=163 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=63 Participants
|
85 Participants
n=100 Participants
|
139 Participants
n=163 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=63 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=163 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=63 Participants
|
2 Participants
n=100 Participants
|
2 Participants
n=163 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=63 Participants
|
5 participants
n=100 Participants
|
10 participants
n=163 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=63 Participants
|
95 participants
n=100 Participants
|
153 participants
n=163 Participants
|
|
Baseline work status
Working full-time
|
17 Participants
n=63 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
40 Participants
n=98 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
57 Participants
n=161 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
|
Baseline work status
Retired
|
14 Participants
n=63 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
29 Participants
n=98 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
43 Participants
n=161 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
|
Baseline work status
Not working, unable to work
|
17 Participants
n=63 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
18 Participants
n=98 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
35 Participants
n=161 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
|
Baseline work status
Not working but able to work
|
8 Participants
n=63 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
7 Participants
n=98 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
15 Participants
n=161 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
|
Baseline work status
Working part-time
|
7 Participants
n=63 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
4 Participants
n=98 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
11 Participants
n=161 Participants • 63/63 ventral participants and 98/100 dorsal participants reported their baseline work status.
|
|
ASA physical status class
1 (healthy)
|
0 Participants
n=61 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
1 Participants
n=98 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
1 Participants
n=159 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
|
ASA physical status class
II (mild systemic disease)
|
31 Participants
n=61 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
46 Participants
n=98 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
77 Participants
n=159 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
|
ASA physical status class
III (significant systemic disease)
|
30 Participants
n=61 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
51 Participants
n=98 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
81 Participants
n=159 Participants • 61/63 ventral participants and 98/100 dorsal participants have reported ASA physical status class.
|
|
Number of stenotic levels
|
2.8 levels
STANDARD_DEVIATION 0.7 • n=63 Participants
|
2.8 levels
STANDARD_DEVIATION 0.8 • n=100 Participants
|
2.8 levels
STANDARD_DEVIATION 0.7 • n=163 Participants
|
|
Number of stenotic levels
1
|
0 Participants
n=63 Participants
|
3 Participants
n=100 Participants
|
3 Participants
n=163 Participants
|
|
SF-36 mental component score
|
45.6 units on a scale
STANDARD_DEVIATION 12.2 • n=63 Participants
|
46.6 units on a scale
STANDARD_DEVIATION 12.1 • n=100 Participants
|
46.2 units on a scale
STANDARD_DEVIATION 12.1 • n=163 Participants
|
|
Number of stenotic levels
2
|
22 Participants
n=63 Participants
|
29 Participants
n=100 Participants
|
51 Participants
n=163 Participants
|
|
Number of stenotic levels
3
|
33 Participants
n=63 Participants
|
55 Participants
n=100 Participants
|
88 Participants
n=163 Participants
|
|
Number of stenotic levels
4
|
8 Participants
n=63 Participants
|
11 Participants
n=100 Participants
|
19 Participants
n=163 Participants
|
|
Number of stenotic levels
5
|
0 Participants
n=63 Participants
|
2 Participants
n=100 Participants
|
2 Participants
n=163 Participants
|
|
Neck Disability Index (NDI) score
|
38.6 units on a scale
STANDARD_DEVIATION 19.1 • n=63 Participants
|
35.3 units on a scale
STANDARD_DEVIATION 20.4 • n=100 Participants
|
36.6 units on a scale
STANDARD_DEVIATION 19.9 • n=163 Participants
|
PRIMARY outcome
Timeframe: 1 year and 2 yearPopulation: Primary analysis was conducted as-randomized (ventral vs. dorsal). At 1 year, there were 60/63 ventral participants and 95/100 dorsal participants available for analysis. At 2 year, there were 51/63 ventral participants and 79/100 dorsal participants available for analysis. Estimated mean change was calculated from the baseline SF-36 PCS score.
Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life.
Outcome measures
| Measure |
Ventral
n=60 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=97 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
1 year
|
5.9 units on a scale
Standard Deviation 8.2
|
6.2 units on a scale
Standard Deviation 10.2
|
—
|
|
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
2 year
|
5.2 units on a scale
Standard Deviation 7.9
|
6.0 units on a scale
Standard Deviation 11.0
|
—
|
SECONDARY outcome
Timeframe: Pre-operative, 1 year and 2 yearPopulation: Secondary outcomes in the primary analysis were analyzed as-randomized (ventral vs. dorsal). At 1 year, there were 60/63 ventral participants and 95/100 dorsal participants available for analysis. At 2 year, there were 51/63 ventral participants and 79/100 dorsal participants available for analysis.
Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary (PCS) scores range from 0 to 100, with higher scores representing better quality of life. A typical patient with cervical myelopathy who is being recommended surgery would have a score between 30 and 40.
Outcome measures
| Measure |
Ventral
n=60 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=97 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Pre-operative
|
37.6 units on a scale
Standard Deviation 8.9
|
37.6 units on a scale
Standard Deviation 9.9
|
—
|
|
Short Form-36 (SF-36) Physical Component Summary (PCS) Score
1 year
|
43.5 units on a scale
Standard Deviation 10.7
|
44.0 units on a scale
Standard Deviation 10.5
|
—
|
|
Short Form-36 (SF-36) Physical Component Summary (PCS) Score
2 year
|
43.4 units on a scale
Standard Deviation 10.5
|
43.6 units on a scale
Standard Deviation 10.8
|
—
|
SECONDARY outcome
Timeframe: Pre-operative, 1 year and 2 yearPopulation: Secondary outcomes in the primary analysis were analyzed as-randomized (ventral vs. dorsal). At 1 year, there were 60/63 ventral participants and 97/100 dorsal participants available for analysis. At 2 year, there were 51/63 ventral participants and 79/100 dorsal participants available for analysis.
Standard instrument for measuring self-rated disability secondary to neck pain. The NDI ranges from 0 to 100, with lower scores representing less disability. A typical patient with moderate neck pain and disability would have a score between 20 and 40.
Outcome measures
| Measure |
Ventral
n=60 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=97 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Oswestry Neck Disability Index (NDI)
1 year
|
22.9 units on a scale
Standard Deviation 20.1
|
22.5 units on a scale
Standard Deviation 20.3
|
—
|
|
Oswestry Neck Disability Index (NDI)
Pre-operative
|
38.1 units on a scale
Standard Deviation 19.1
|
35.4 units on a scale
Standard Deviation 20.5
|
—
|
|
Oswestry Neck Disability Index (NDI)
2 year
|
20.4 units on a scale
Standard Deviation 20.2
|
22.1 units on a scale
Standard Deviation 21.3
|
—
|
SECONDARY outcome
Timeframe: Pre-operative, 1 year and 2 yearPopulation: Secondary outcomes in the primary analysis were analyzed as-randomized (ventral vs. dorsal). At 1 year, there were 60/63 ventral participants and 97/100 dorsal participants available for analysis. At 2 year, there were 51/63 ventral participants and 79/100 dorsal participants available for analysis.
Standardized measure of health related quality of life. For the EQ-5D score, 0 indicates death and 1 indicates a perfect health state. EQ-5D scores between 0.6 and 0.7 represent a moderate but significant reduction in overall health-related quality of life.
Outcome measures
| Measure |
Ventral
n=60 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=97 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
EuroQol-5D
Pre-operative
|
0.64 units on a scale
Standard Deviation 0.21
|
0.61 units on a scale
Standard Deviation 0.21
|
—
|
|
EuroQol-5D
1 year
|
0.77 units on a scale
Standard Deviation 0.21
|
0.76 units on a scale
Standard Deviation 0.19
|
—
|
|
EuroQol-5D
2 year
|
0.78 units on a scale
Standard Deviation 0.20
|
0.78 units on a scale
Standard Deviation 0.19
|
—
|
SECONDARY outcome
Timeframe: Pre-operative and 1 yearPopulation: Secondary outcomes in the primary analysis were analyzed as-randomized (ventral vs. dorsal). At 1 year, there were 60/63 ventral participants and 91/100 dorsal participants available for analysis. At 2 year, there were 51/63 ventral participants and 79/100 dorsal participants available for analysis.
Short instrument for the functional assessment of patients. The scale ranges from 0 to 17, with higher scores representing less dysfunction due to myelopathy. A typical patient with moderate cervical myelopathy has an mJOA score between 12 and 14.
Outcome measures
| Measure |
Ventral
n=60 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=91 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Modified Japanese Orthopedic Association Score mJOA
Pre-operative
|
12.2 units on a scale
Standard Deviation 2.7
|
12.2 units on a scale
Standard Deviation 2.3
|
—
|
|
Modified Japanese Orthopedic Association Score mJOA
1 year
|
14.5 units on a scale
Standard Deviation 2.6
|
14.2 units on a scale
Standard Deviation 2.5
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Secondary outcomes in the primary analysis were analyzed as-randomized (ventral vs. dorsal). At 1 year, there were 49/63 ventral participants and 78/100 dorsal participants available for analysis.
Sagittal vertical axis was measured at 1 year postoperatively.
Outcome measures
| Measure |
Ventral
n=49 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=78 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Sagittal Balance Measurements
|
23.2 mm
Standard Deviation 11.8
|
26.7 mm
Standard Deviation 13.3
|
—
|
SECONDARY outcome
Timeframe: Within 1 year of surgeryPopulation: All patients reported diagnostic imaging (MRI, x-ray, or CT), along with physical therapy and ongoing (at 1 year) physical therapy, opioid use and ongoing (at 1 year) opioid use, along with appointments with physicians. Data was collected at 1, 3, and 6 months after surgery, as well as at 1 year. The data presented is accumulative over the 1 year after surgery.
Patient diary capturing out of pocket health utilization related to cervical surgery. The cumulative health resource utilization over 1-year is reported for the 'as treated' cohorts. Patients reported diagnostic imaging (MRI, x-ray, or CT), along with physical therapy and ongoing (at 1 year) physical therapy, opioid use and ongoing (at 1 year) opioid use, along with appointments with physicians. Data was collected at 1, 3, and 6 months and 1 year after surgery. The data presented is accumulative over the 1 year after surgery.
Outcome measures
| Measure |
Ventral
n=66 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=69 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
n=28 Participants
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Diagnostic imaging
|
52 occurrences
|
60 occurrences
|
17 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
MRI
|
28 occurrences
|
32 occurrences
|
11 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
CT
|
12 occurrences
|
11 occurrences
|
4 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
x-ray
|
50 occurrences
|
51 occurrences
|
13 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Physical Therapy
|
34 occurrences
|
39 occurrences
|
13 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Ongoing physical therapy 1 year after surgery
|
11 occurrences
|
15 occurrences
|
0 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Opioid use
|
30 occurrences
|
45 occurrences
|
11 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Ongoing opioid use 1 year after surgery
|
6 occurrences
|
11 occurrences
|
0 occurrences
|
|
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Physician Appointments
|
16 occurrences
|
26 occurrences
|
6 occurrences
|
SECONDARY outcome
Timeframe: Pre-operative, 1, 3 and 6 months and 1 yearPopulation: Only patients who were working either full- or part-time at baseline were included in the return to work analysis.
Work status was recorded for all patients (working full-time; working part-time; not working, unable to work; not working, but able to work; or retired) at each follow-up through 1 year.
Outcome measures
| Measure |
Ventral
n=27 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=29 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
n=12 Participants
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Pre-operatively
|
27 Participants
|
29 Participants
|
12 Participants
|
|
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
1 month
|
9 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
3 month
|
19 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
6 month
|
19 Participants
|
16 Participants
|
8 Participants
|
|
Number of Participants With Continued Full or Part Time Work Status at Each Follow Up Time Point by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
1 year
|
19 Participants
|
18 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction.
Outcome measures
| Measure |
Ventral
n=66 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=69 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
n=28 Participants
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Any Complications
|
31 participants
|
20 participants
|
3 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Major complications
|
14 participants
|
15 participants
|
2 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Prolonged dysphagia
|
9 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Motor radiculopathy
|
1 participants
|
8 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Spinal cord injury
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Deep vein thrombosis
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Delayed wound healing
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Minor complications
|
18 participants
|
5 participants
|
1 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Dysphagia
|
18 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Infection
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Motor radiculopathy (resolved within 3 months)
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Reoperations (within 2 year)
|
4 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Readmissions (within 30 days)
|
0 participants
|
6 participants
|
1 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Cervical (C5) paresis
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Pulmonary embolism
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Ileus
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Uncontrolled neck pain
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Infection (needing readmission)
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Fever (unknown source)
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 months, 1 yearPopulation: Complication were assessed by the actual treatment approach the participant received. 66 participants underwent ventral surgery and 97 participants underwent dorsal surgery.
Dysphagia is considered swallowing difficulty. Difficulty swallowing that resolved within 3 months was considered a minor complication, while prolonged (on going after 3 months) dysphagia was considered a major complication.
Outcome measures
| Measure |
Ventral
n=66 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=69 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months
Minor (resolved within 3 months)
|
18 participants
|
0 participants
|
—
|
|
Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months
Major (prolonged - ongoing after 3 month through 1 year follow-up)
|
9 participants
|
0 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-operative, 1 year and 2 yearPopulation: At 1 year, 63/66 ventral participants, 66/69 dorsal decompression with fusion participants, and 26/28 dorsal laminoplasty participants were available for analysis. At 2 year, 54/66 ventral participants, 55/69 dorsal decompression with fusion participants, and 21/28 dorsal laminoplasty participants were available for analysis.
Standardized measure of patient's functional health and well being as reported by the patient. The SF-36 physical component summary scores range from 0 to 100, with higher scores representing better quality of life.
Outcome measures
| Measure |
Ventral
n=63 Participants
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal
n=68 Participants
Dorsal Decompression with Fusion or Dorsal Laminoplasty
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
Dorsal Laminoplasty
n=26 Participants
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
Pre-operative
|
38.1 units on a scale
Standard Deviation 9.1
|
37.3 units on a scale
Standard Deviation 9.4
|
37.3 units on a scale
Standard Deviation 11.1
|
|
Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
1 year
|
43.8 units on a scale
Standard Deviation 10.9
|
42.5 units on a scale
Standard Deviation 10.4
|
47.1 units on a scale
Standard Deviation 9.7
|
|
Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
2 year
|
43.8 units on a scale
Standard Deviation 10.7
|
41.5 units on a scale
Standard Deviation 10.6
|
48.3 units on a scale
Standard Deviation 9.3
|
Adverse Events
Ventral
Serious events: 14 serious events
Other events: 18 other events
Deaths: 1 deaths
Dorsal Decompression With Fusion
Serious events: 15 serious events
Other events: 5 other events
Deaths: 1 deaths
Dorsal Laminoplasty
Serious events: 2 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ventral
n=66 participants at risk
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal Decompression With Fusion
n=69 participants at risk
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
|
Dorsal Laminoplasty
n=28 participants at risk
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Prolonged dysphagia
|
13.6%
9/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Musculoskeletal and connective tissue disorders
Motor radiculopathy (ongoing at 3 months)
|
1.5%
1/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
11.6%
8/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Nervous system disorders
Spinal cord injury
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
3.6%
1/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Skin and subcutaneous tissue disorders
Delayed wound healing
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Surgical and medical procedures
Reoperations
|
6.1%
4/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
5.8%
4/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Nervous system disorders
Cervical (C5) paresis (readmissions within 30 days)
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
2.9%
2/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Vascular disorders
Pulmonary Embolism (readmissions within 30 days)
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Gastrointestinal disorders
Ileus (readmissions within 30 days)
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Musculoskeletal and connective tissue disorders
Uncontrolled neck pain (readmissions within 30 days)
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
General disorders
Infection (readmissions within 30 days)
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
General disorders
Fever (readmissions within 30 days)
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
3.6%
1/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
Other adverse events
| Measure |
Ventral
n=66 participants at risk
Ventral Decompression with Fusion
Ventral (Front) decompression with Fusion: Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
|
Dorsal Decompression With Fusion
n=69 participants at risk
Dorsal (Back) Decompression with Fusion: Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
|
Dorsal Laminoplasty
n=28 participants at risk
Dorsal (back) Laminoplasty: Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Dysphagia
|
27.3%
18/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
General disorders
Infection
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
2.9%
2/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
3.6%
1/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
Musculoskeletal and connective tissue disorders
Motor radiculopathy
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
2.9%
2/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
|
General disorders
Delayed wound healing
|
0.00%
0/66 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
1.4%
1/69 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
0.00%
0/28 • Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
Major complications included adverse events that were ongoing at 3 months, reoperations within 2 years, and 30-day readmissions. Minor complications were those that resolved within 3 months. All cases of postoperative motor radiculopathy were related to C5 nerve root dysfunction. Patients may have had more than 1 complication, so totals may be less that the sum of the categories.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place