Cervical Spondylosis With Myelopathy, Kyphosis Post Surgical, Myelopathy Cervical, Neck Pain, Ossification of Posterior Longitudinal Ligament
Conditions
Keywords
Laminoplasty, Laminectomy
Brief summary
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
Detailed description
Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty. There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1\ 3 year
Interventions
PROCEDUREC3 laminectomy
C3 laminectomy preserving semispinalis cervicis inserted into the axis.
PROCEDUREC3 laminoplasty
Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Using a generator of www.randomization.com, 100 subjects randomized into blocks of 50 and 50. To reproduce this plan, use the seed 3169 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally. and (case-sensitive) treatment labels as entered originally. After randomization of 100 subjects, additional 26 subjects randomized into blocks of 13 and13. To reproduce this plan, use the seed 5134 along with the number of subjects per block/number of blocks and (case-sensitive) treatment labels as entered originally.
Intervention model description
A randomized controlled trial, assigning subjects to two groups: C3 laminectomy with laminoplasty and C3-6 laminoplasty
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cervical stenosis patients with or without cervical myelopathy.
Exclusion criteria
* Metastatic cancer patients. * Any combined fracture. * Previous surgery to cervical spine. * inflammatory joint disease * psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C2-C7 Lordosis | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
| the Neck Disability Index (NDI) | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | scores from 0 to 50 with 50 being the worst performance status related to neck pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Sagittal Vertical Axis (cSVA) | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
| T1 Slope | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
| T1 Slope Minus Cervical Lordosis | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
| C2-C3 Interlaminar Spontaneous Fusion | at 2 year | Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series. |
| C2-C3 Lordosis | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
| Posterior Neck With Numering Rating Scale (NRS-N) | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. |
| Upper Limb Pain With Numering Rating Scale (NRS-L) | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level. |
| Estimated Intraoperative Blood Loss | Intraoperative | Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists. |
| Operative Time | Intraoperative | Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin). |
| EuroQol Five-dimensional Questionnaire (EQ-5D) Scores | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO). |
| C4-C7 Lordosis | at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements) | Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| C3 Laminectomy With C4-6 Laminoplasty Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.
C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis. | 51 |
| C3-6 Laminoplasty Cervical myelopathy patients who underwent C3-6 laminoplasty.
C3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis. | 58 |
| Total | 109 |
Baseline characteristics
| Characteristic | C3 Laminectomy With C4-6 Laminoplasty | C3-6 Laminoplasty | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 10.4 | 58.3 years STANDARD_DEVIATION 11.3 | 59.5 years STANDARD_DEVIATION 10.9 |
| BMI | 25.0 Kg/m2 STANDARD_DEVIATION 3 | 25.5 Kg/m2 STANDARD_DEVIATION 3.7 | 25.3 Kg/m2 STANDARD_DEVIATION 3.4 |
| Disease Cerivcal spondylotic myelopathy | 30 Participants | 31 Participants | 61 Participants |
| Disease Ossification of posterior longitudinal ligament | 21 Participants | 27 Participants | 48 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 37 Participants | 44 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 61 |
| other Total, other adverse events | 0 / 61 | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 | 0 / 61 |
Outcome results
Primary
C2-C7 Lordosis
Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | C2-C7 Lordosis | 11.0 ° | Standard Error 0.8 |
| C3-6 Laminoplasty | C2-C7 Lordosis | 10.9 ° | Standard Error 0.8 |
Primary
the Neck Disability Index (NDI)
scores from 0 to 50 with 50 being the worst performance status related to neck pain.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | the Neck Disability Index (NDI) | 12.8 score | Standard Error 1 |
| C3-6 Laminoplasty | the Neck Disability Index (NDI) | 8.6 score | Standard Error 1 |
Secondary
C2-C3 Interlaminar Spontaneous Fusion
Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.
Time frame: at 2 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | C2-C3 Interlaminar Spontaneous Fusion | 5 Participants |
| C3-6 Laminoplasty | C2-C3 Interlaminar Spontaneous Fusion | 26 Participants |
Secondary
C2-C3 Lordosis
Measuring C2-C3 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | C2-C3 Lordosis | 7.1 ° | Standard Error 0.5 |
| C3-6 Laminoplasty | C2-C3 Lordosis | 3.2 ° | Standard Error 0.5 |
Secondary
C4-C7 Lordosis
Measuring C4-C7 lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | C4-C7 Lordosis | 3.9 ° | Standard Error 0.8 |
| C3-6 Laminoplasty | C4-C7 Lordosis | 7.7 ° | Standard Error 0.7 |
Secondary
Cervical Sagittal Vertical Axis (cSVA)
Measuring cervical sagittal vertical axis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | Cervical Sagittal Vertical Axis (cSVA) | 31.6 mm | Standard Error 1.4 |
| C3-6 Laminoplasty | Cervical Sagittal Vertical Axis (cSVA) | 25.5 mm | Standard Error 1.3 |
Secondary
Estimated Intraoperative Blood Loss
Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.
Time frame: Intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | Estimated Intraoperative Blood Loss | 169 cc | Standard Deviation 145 |
| C3-6 Laminoplasty | Estimated Intraoperative Blood Loss | 182 cc | Standard Deviation 159 |
Secondary
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores
Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO).
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | EuroQol Five-dimensional Questionnaire (EQ-5D) Scores | 0.661 score | Standard Error 0.025 |
| C3-6 Laminoplasty | EuroQol Five-dimensional Questionnaire (EQ-5D) Scores | 0.743 score | Standard Error 0.024 |
Secondary
Operative Time
Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).
Time frame: Intraoperative
Population: who completed 1-year to 3-year follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | Operative Time | 126 minutes | Standard Deviation 42 |
| C3-6 Laminoplasty | Operative Time | 118 minutes | Standard Deviation 40 |
Secondary
Posterior Neck With Numering Rating Scale (NRS-N)
Measuring pain intensity of the posterior neck with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | Posterior Neck With Numering Rating Scale (NRS-N) | 2.8 score | Standard Error 0.3 |
| C3-6 Laminoplasty | Posterior Neck With Numering Rating Scale (NRS-N) | 2.0 score | Standard Error 0.3 |
Secondary
T1 Slope
Measuring T1 slope by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | T1 Slope | 25.8 ° | Standard Error 0.6 |
| C3-6 Laminoplasty | T1 Slope | 25.3 ° | Standard Error 0.6 |
Secondary
T1 Slope Minus Cervical Lordosis
Measuring T1 slope minus cervical lordosis by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | T1 Slope Minus Cervical Lordosis | 15.0 ° | Standard Error 1 |
| C3-6 Laminoplasty | T1 Slope Minus Cervical Lordosis | 14.9 ° | Standard Error 0.9 |
Secondary
Upper Limb Pain With Numering Rating Scale (NRS-L)
Measuring pain intensity of the upper limb with numeric rating scale (NRS), rated 1 to 10 with 10 being the most severe pain level.
Time frame: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| C3 Laminectomy With C4-6 Laminoplasty | Upper Limb Pain With Numering Rating Scale (NRS-L) | 3.7 score | Standard Error 0.4 |
| C3-6 Laminoplasty | Upper Limb Pain With Numering Rating Scale (NRS-L) | 2.8 score | Standard Error 0.3 |