Trial Outcomes & Findings for Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty (NCT NCT05006495)

NCT ID: NCT05006495

Last Updated: 2024-06-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 126 participants
• Primary outcome timeframe: at 1, 2, 3 year (linear mixed-effect model analysis was used for repeated measurements)
• Results posted on: 2024-06-21

Participant Flow

Participant milestones

Measure	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.	C3-6 Laminoplasty Cervical myelopathy patients who underwent C3-6 laminoplasty. C3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
Overall Study STARTED	61	61
Overall Study COMPLETED	51	58
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty. C3 laminoplasty: Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.	Total n=109 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 10.4 • n=51 Participants	58.3 years STANDARD_DEVIATION 11.3 • n=58 Participants	59.5 years STANDARD_DEVIATION 10.9 • n=109 Participants
Sex: Female, Male Female	14 Participants n=51 Participants	14 Participants n=58 Participants	28 Participants n=109 Participants
Sex: Female, Male Male	37 Participants n=51 Participants	44 Participants n=58 Participants	81 Participants n=109 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Disease Cerivcal spondylotic myelopathy	30 Participants n=51 Participants	31 Participants n=58 Participants	61 Participants n=109 Participants
Disease Ossification of posterior longitudinal ligament	21 Participants n=51 Participants	27 Participants n=58 Participants	48 Participants n=109 Participants
BMI	25.0 Kg/m2 STANDARD_DEVIATION 3.0 • n=51 Participants	25.5 Kg/m2 STANDARD_DEVIATION 3.7 • n=58 Participants	25.3 Kg/m2 STANDARD_DEVIATION 3.4 • n=109 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
C2-C7 Lordosis	11.0 ° Standard Error 0.8	10.9 ° Standard Error 0.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
the Neck Disability Index (NDI)	12.8 score Standard Error 1.0	8.6 score Standard Error 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
C2-C3 Lordosis	7.1 ° Standard Error 0.5	3.2 ° Standard Error 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
C4-C7 Lordosis	3.9 ° Standard Error 0.8	7.7 ° Standard Error 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
Cervical Sagittal Vertical Axis (cSVA)	31.6 mm Standard Error 1.4	25.5 mm Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
T1 Slope	25.8 ° Standard Error 0.6	25.3 ° Standard Error 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
T1 Slope Minus Cervical Lordosis	15.0 ° Standard Error 1.0	14.9 ° Standard Error 0.9

SECONDARY outcome

Timeframe: at 2 year

Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
C2-C3 Interlaminar Spontaneous Fusion	5 Participants	26 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
EuroQol Five-dimensional Questionnaire (EQ-5D) Scores	0.661 score Standard Error 0.025	0.743 score Standard Error 0.024

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
Posterior Neck With Numering Rating Scale (NRS-N)	2.8 score Standard Error 0.3	2.0 score Standard Error 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
Upper Limb Pain With Numering Rating Scale (NRS-L)	3.7 score Standard Error 0.4	2.8 score Standard Error 0.3

SECONDARY outcome

Timeframe: Intraoperative

Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists.

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
Estimated Intraoperative Blood Loss	169 cc Standard Deviation 145	182 cc Standard Deviation 159

SECONDARY outcome

Timeframe: Intraoperative

Population: who completed 1-year to 3-year follow-up

Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin).

Outcome measures

Measure	C3 Laminectomy With C4-6 Laminoplasty n=51 Participants Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty. C3 laminectomy: C3 laminectomy preserving semispinalis cervicis inserted into the axis.	C3-6 Laminoplasty n=58 Participants Cervical myelopathy patients who underwent C3-6 laminoplasty.
Operative Time	126 minutes Standard Deviation 42	118 minutes Standard Deviation 40

Adverse Events

C3 Laminectomy With C4-6 Laminoplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C3-6 Laminoplasty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Researcher of Clinical Trials

Seoul National University Hospital

Phone: +821049051485

Email: junhiya@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place