Cervical Spondylosis With Myelopathy
Conditions
Keywords
cervical spondylotic myelopathy, degenerative cervical spondylosis, spinal fusion
Brief summary
The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world. This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.
Detailed description
Patients' images will be transmitted electronically (without identifying information) to a group of 15 CSM surgeon investigators for their expert opinion. They will provide their opinion on surgical strategy. Equipoise for randomization will be established using this spinal experts network polling mechanism. If randomized, the patient will be randomized to one of the two treatment approaches - either Ventral (front) (treatment A) or Dorsal (back) (treatment B) approach. If randomized to treatment A (front surgery), the patient will receive decompression/fusion from the front of the neck. If randomized to treatment B (dorsal/back surgery), then the patient and their surgeon will select which posterior procedure they will receive (either dorsal decompression/fusion or dorsal laminoplasty). Treatment A: Decompression/fusion from the front of the neck. Treatment B: Dorsal/posterior neck surgery (one of the two surgical procedures listed below): Dorsal decompression/fusion or dorsal laminoplasty (no fusion) Functional outcomes will be determined using well-known quantitative scales (SF-36, Oswestry Neck Disability Index (NDI), mJOA, and EuroQol-5D). These instruments will be administered pre-op, 3 months, 6 months, and at 1 year. Additionally, functional outcomes instruments (SF-36, Oswestry Neck Disability Index, and EuroQol-5D) will be collected annually at years 2,3,4 and 5. Pre-op imaging will include a cervical MRI and cervical CT as well as cervical flexion/extension films and standing cervical-thoracic-lumbar-sacral x-ray . A cervical MRI will be performed at 3 months. At 1 year (randomized patients only) will undergo cervical flexion/ extension xrays and standing cervical-thoracic-lumbar-sacral x-ray . A cervical CT will be performed only if the Oswestry NDI score is \> 30.
Interventions
PROCEDUREVentral (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.
PROCEDUREDorsal (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.
PROCEDUREDorsal (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.
Sponsors
Lahey Clinic
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* CSM (≥2 levels of spinal cord compression from C3 to C7) * Present with ≥2 of the following symptoms/signs: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction.
Exclusion criteria
* C2-C7 kyphosis\>5º (measured in standing neutral cervical spine radiograph), * Segmental kyphotic deformity (defined by ≥3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT), * Structurally significant ossification of posterior longitudinal ligament (OPLL - measured on cervical spine CT), * Previous cervical spine surgery * Significant active health-related co-morbidity (Anesthesia Class IV or higher).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year | 1 year and 2 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol-5D | Pre-operative, 1 year and 2 year | 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. |
| Short Form-36 (SF-36) Physical Component Summary (PCS) Score | Pre-operative, 1 year and 2 year | 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. |
| Modified Japanese Orthopedic Association Score mJOA | Pre-operative and 1 year | 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. |
| Sagittal Balance Measurements | 1 year | Sagittal vertical axis was measured at 1 year postoperatively. |
| Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Within 1 year of 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. |
| 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-operative, 1, 3 and 6 months and 1 year | 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. |
| Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | 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. |
| Oswestry Neck Disability Index (NDI) | Pre-operative, 1 year and 2 year | 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. |
| Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months | 3 months, 1 year | 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. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORZoher Ghogawala, MD
Lahey Clinic, Inc.
Participant flow
Recruitment details
Participants were recruited between April 1, 2014 and March 30, 2018 from 15 study sites.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| 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. | 100 |
| Total | 163 |
Baseline characteristics
| Characteristic | Ventral | Total | Dorsal |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 7.2 | 62.3 years STANDARD_DEVIATION 8.2 | 62.5 years STANDARD_DEVIATION 8.8 |
| ASA physical status class 1 (healthy) | 0 Participants | 1 Participants | 1 Participants |
| ASA physical status class III (significant systemic disease) | 30 Participants | 81 Participants | 51 Participants |
| ASA physical status class II (mild systemic disease) | 31 Participants | 77 Participants | 46 Participants |
| Baseline work status Not working but able to work | 8 Participants | 15 Participants | 7 Participants |
| Baseline work status Not working, unable to work | 17 Participants | 35 Participants | 18 Participants |
| Baseline work status Retired | 14 Participants | 43 Participants | 29 Participants |
| Baseline work status Working full-time | 17 Participants | 57 Participants | 40 Participants |
| Baseline work status Working part-time | 7 Participants | 11 Participants | 4 Participants |
| EQ-5D score | 0.64 units on a scale STANDARD_DEVIATION 0.21 | 0.62 units on a scale STANDARD_DEVIATION 0.21 | 0.61 units on a scale STANDARD_DEVIATION 0.21 |
| EQ-5D visual analog scale score | 61.7 units on a scale STANDARD_DEVIATION 20.9 | 62.5 units on a scale STANDARD_DEVIATION 21.3 | 63.1 units on a scale STANDARD_DEVIATION 21.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 157 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| mJOA scale score | 12.2 units on a scale STANDARD_DEVIATION 2.7 | 12.2 units on a scale STANDARD_DEVIATION 2.4 | 12.1 units on a scale STANDARD_DEVIATION 2.2 |
| Neck Disability Index (NDI) score | 38.6 units on a scale STANDARD_DEVIATION 19.1 | 36.6 units on a scale STANDARD_DEVIATION 19.9 | 35.3 units on a scale STANDARD_DEVIATION 20.4 |
| Number of stenotic levels 1 | 0 Participants | 3 Participants | 3 Participants |
| Number of stenotic levels 2 | 22 Participants | 51 Participants | 29 Participants |
| Number of stenotic levels 3 | 33 Participants | 88 Participants | 55 Participants |
| Number of stenotic levels 4 | 8 Participants | 19 Participants | 11 Participants |
| Number of stenotic levels 5 | 0 Participants | 2 Participants | 2 Participants |
| Number of stenotic levels | 2.8 levels STANDARD_DEVIATION 0.7 | 2.8 levels STANDARD_DEVIATION 0.7 | 2.8 levels STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 54 Participants | 139 Participants | 85 Participants |
| Region of Enrollment Canada | 5 participants | 10 participants | 5 participants |
| Region of Enrollment United States | 58 participants | 153 participants | 95 participants |
| Sex: Female, Male Female | 29 Participants | 80 Participants | 51 Participants |
| Sex: Female, Male Male | 34 Participants | 83 Participants | 49 Participants |
| SF-36 mental component score | 45.6 units on a scale STANDARD_DEVIATION 12.2 | 46.2 units on a scale STANDARD_DEVIATION 12.1 | 46.6 units on a scale STANDARD_DEVIATION 12.1 |
| SF-36 physical component score | 37.4 units on a scale STANDARD_DEVIATION 8.8 | 37.3 units on a scale STANDARD_DEVIATION 9.5 | 37.3 units on a scale STANDARD_DEVIATION 9.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 66 | 1 / 69 | 2 / 28 |
| other Total, other adverse events | 18 / 66 | 5 / 69 | 1 / 28 |
| serious Total, serious adverse events | 14 / 66 | 15 / 69 | 2 / 28 |
Outcome results
Primary
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
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.
Time frame: 1 year and 2 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventral | 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 |
| Ventral | 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 |
| Dorsal | Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year | 1 year | 6.2 units on a scale | Standard Deviation 10.2 |
| Dorsal | Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year | 2 year | 6.0 units on a scale | Standard Deviation 11 |
Secondary
Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
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.
Time frame: Within 1 year of surgery
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Opioid use | 30 occurrences |
| Ventral | 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 |
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Diagnostic imaging | 52 occurrences |
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | MRI | 28 occurrences |
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | CT | 12 occurrences |
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | x-ray | 50 occurrences |
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Physical Therapy | 34 occurrences |
| Ventral | 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 |
| Ventral | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Physician Appointments | 16 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | x-ray | 51 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Opioid use | 45 occurrences |
| Dorsal | 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 | 11 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Physician Appointments | 26 occurrences |
| Dorsal | 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 | 15 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Diagnostic imaging | 60 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | CT | 11 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Physical Therapy | 39 occurrences |
| Dorsal | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | MRI | 32 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Physical Therapy | 13 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | CT | 4 occurrences |
| Dorsal Laminoplasty | 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 | 0 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | x-ray | 13 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Physician Appointments | 6 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | MRI | 11 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Opioid use | 11 occurrences |
| Dorsal Laminoplasty | Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Diagnostic imaging | 17 occurrences |
| Dorsal Laminoplasty | 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 | 0 occurrences |
Secondary
EuroQol-5D
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.
Time frame: Pre-operative, 1 year and 2 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventral | EuroQol-5D | 2 year | 0.78 units on a scale | Standard Deviation 0.2 |
| Ventral | EuroQol-5D | Pre-operative | 0.64 units on a scale | Standard Deviation 0.21 |
| Ventral | EuroQol-5D | 1 year | 0.77 units on a scale | Standard Deviation 0.21 |
| Dorsal | EuroQol-5D | 1 year | 0.76 units on a scale | Standard Deviation 0.19 |
| Dorsal | EuroQol-5D | 2 year | 0.78 units on a scale | Standard Deviation 0.19 |
| Dorsal | EuroQol-5D | Pre-operative | 0.61 units on a scale | Standard Deviation 0.21 |
Secondary
Modified Japanese Orthopedic Association Score mJOA
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.
Time frame: Pre-operative and 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventral | Modified Japanese Orthopedic Association Score mJOA | Pre-operative | 12.2 units on a scale | Standard Deviation 2.7 |
| Ventral | Modified Japanese Orthopedic Association Score mJOA | 1 year | 14.5 units on a scale | Standard Deviation 2.6 |
| Dorsal | Modified Japanese Orthopedic Association Score mJOA | Pre-operative | 12.2 units on a scale | Standard Deviation 2.3 |
| Dorsal | Modified Japanese Orthopedic Association Score mJOA | 1 year | 14.2 units on a scale | Standard Deviation 2.5 |
Secondary
Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
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.
Time frame: Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Delayed wound healing | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Major complications | 14 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Cervical (C5) paresis | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Minor complications | 18 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Fever (unknown source) | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Readmissions (within 30 days) | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Dysphagia | 18 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Uncontrolled neck pain | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Reoperations (within 2 year) | 4 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Infection | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Prolonged dysphagia | 9 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Motor radiculopathy (resolved within 3 months) | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Any Complications | 31 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Ileus | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Spinal cord injury | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Infection (needing readmission) | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Pulmonary embolism | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Deep vein thrombosis | 0 participants |
| Ventral | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Motor radiculopathy | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Uncontrolled neck pain | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Motor radiculopathy | 8 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Motor radiculopathy (resolved within 3 months) | 2 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Any Complications | 20 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Major complications | 15 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Prolonged dysphagia | 0 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Spinal cord injury | 0 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Deep vein thrombosis | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Delayed wound healing | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Minor complications | 5 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Dysphagia | 0 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Infection | 2 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Reoperations (within 2 year) | 4 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Readmissions (within 30 days) | 6 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Cervical (C5) paresis | 2 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Pulmonary embolism | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Ileus | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Infection (needing readmission) | 1 participants |
| Dorsal | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Fever (unknown source) | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Readmissions (within 30 days) | 1 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Delayed wound healing | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Fever (unknown source) | 1 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Cervical (C5) paresis | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Spinal cord injury | 1 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Infection (needing readmission) | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Pulmonary embolism | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Prolonged dysphagia | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Motor radiculopathy | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Ileus | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Major complications | 2 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Any Complications | 3 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Infection | 1 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Motor radiculopathy (resolved within 3 months) | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Dysphagia | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Uncontrolled neck pain | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Reoperations (within 2 year) | 0 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Minor complications | 1 participants |
| Dorsal Laminoplasty | Number of Participants With Complications by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Deep vein thrombosis | 0 participants |
Secondary
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
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.
Time frame: Pre-operative, 1, 3 and 6 months and 1 year
Population: Only patients who were working either full- or part-time at baseline were included in the return to work analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ventral | 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 |
| Ventral | 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 |
| Ventral | 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 |
| Ventral | 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 |
| Ventral | 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 |
| Dorsal | 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 | 18 Participants |
| Dorsal | 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 | 5 Participants |
| Dorsal | 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 | 29 Participants |
| Dorsal | 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 | 10 Participants |
| Dorsal | 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 | 16 Participants |
| Dorsal Laminoplasty | 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 | 8 Participants |
| Dorsal Laminoplasty | 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 | 12 Participants |
| Dorsal Laminoplasty | 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 | 8 Participants |
| Dorsal Laminoplasty | 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 | 6 Participants |
| Dorsal Laminoplasty | 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 | 9 Participants |
Secondary
Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months
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.
Time frame: 3 months, 1 year
Population: Complication were assessed by the actual treatment approach the participant received. 66 participants underwent ventral surgery and 97 participants underwent dorsal surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ventral | Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months | Minor (resolved within 3 months) | 18 participants |
| Ventral | Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months | Major (prolonged - ongoing after 3 month through 1 year follow-up) | 9 participants |
| Dorsal | Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months | Minor (resolved within 3 months) | 0 participants |
| Dorsal | Number of Participants With Unresolved Swallowing Difficulty (Complication) at 3 Months | Major (prolonged - ongoing after 3 month through 1 year follow-up) | 0 participants |
Secondary
Oswestry Neck Disability Index (NDI)
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.
Time frame: Pre-operative, 1 year and 2 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventral | Oswestry Neck Disability Index (NDI) | Pre-operative | 38.1 units on a scale | Standard Deviation 19.1 |
| Ventral | Oswestry Neck Disability Index (NDI) | 1 year | 22.9 units on a scale | Standard Deviation 20.1 |
| Ventral | Oswestry Neck Disability Index (NDI) | 2 year | 20.4 units on a scale | Standard Deviation 20.2 |
| Dorsal | Oswestry Neck Disability Index (NDI) | Pre-operative | 35.4 units on a scale | Standard Deviation 20.5 |
| Dorsal | Oswestry Neck Disability Index (NDI) | 1 year | 22.5 units on a scale | Standard Deviation 20.3 |
| Dorsal | Oswestry Neck Disability Index (NDI) | 2 year | 22.1 units on a scale | Standard Deviation 21.3 |
Secondary
Sagittal Balance Measurements
Sagittal vertical axis was measured at 1 year postoperatively.
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ventral | Sagittal Balance Measurements | 23.2 mm | Standard Deviation 11.8 |
| Dorsal | Sagittal Balance Measurements | 26.7 mm | Standard Deviation 13.3 |
Secondary
Short Form-36 (SF-36) Physical Component Summary (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. A typical patient with cervical myelopathy who is being recommended surgery would have a score between 30 and 40.
Time frame: Pre-operative, 1 year and 2 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventral | Short Form-36 (SF-36) Physical Component Summary (PCS) Score | Pre-operative | 37.6 units on a scale | Standard Deviation 8.9 |
| Ventral | Short Form-36 (SF-36) Physical Component Summary (PCS) Score | 1 year | 43.5 units on a scale | Standard Deviation 10.7 |
| Ventral | Short Form-36 (SF-36) Physical Component Summary (PCS) Score | 2 year | 43.4 units on a scale | Standard Deviation 10.5 |
| Dorsal | Short Form-36 (SF-36) Physical Component Summary (PCS) Score | Pre-operative | 37.6 units on a scale | Standard Deviation 9.9 |
| Dorsal | Short Form-36 (SF-36) Physical Component Summary (PCS) Score | 1 year | 44.0 units on a scale | Standard Deviation 10.5 |
| Dorsal | Short Form-36 (SF-36) Physical Component Summary (PCS) Score | 2 year | 43.6 units on a scale | Standard Deviation 10.8 |
Other Pre-specified
Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty
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.
Time frame: Pre-operative, 1 year and 2 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ventral | 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 |
| Ventral | 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 |
| Ventral | 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 |
| Dorsal | Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | 1 year | 42.5 units on a scale | Standard Deviation 10.4 |
| Dorsal | Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | 2 year | 41.5 units on a scale | Standard Deviation 10.6 |
| Dorsal | Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Pre-operative | 37.3 units on a scale | Standard Deviation 9.4 |
| Dorsal Laminoplasty | Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | 2 year | 48.3 units on a scale | Standard Deviation 9.3 |
| Dorsal Laminoplasty | Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | Pre-operative | 37.3 units on a scale | Standard Deviation 11.1 |
| Dorsal Laminoplasty | Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty | 1 year | 47.1 units on a scale | Standard Deviation 9.7 |