| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | 1 year and 2 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| 1 year | - ParticipantsOG00060
- ParticipantsOG00195
| |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Pre-operative, 1 year and 2 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Pre-operative, 1 year and 2 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Pre-operative, 1 year and 2 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Pre-operative and 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Sagittal Balance Measurements | Sagittal vertical axis was measured at 1 year postoperatively. | 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. | Posted | | Mean | Standard Deviation | mm | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | | occurrences | | Within 1 year of surgery | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | Only patients who were working either full- or part-time at baseline were included in the return to work analysis. | Posted | | Count of Participants | | Participants | | Pre-operative, 1, 3 and 6 months and 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Dorsal Decompression With Fusion | 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. |
|
| 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. | | Posted | | Number | | participants | | Complications were assessed at 2 years and categorized to have occurred within 30 days, 1 year or within 2 years. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Dorsal Decompression With Fusion | 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. |
|
| 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. | Complication were assessed by the actual treatment approach the participant received. 66 participants underwent ventral surgery and 97 participants underwent dorsal surgery. | Posted | | Number | | participants | | 3 months, 1 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Pre-operative, 1 year and 2 year | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Dorsal Decompression With Fusion | 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. |
|