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NCT Number: NCT05006495

Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

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Key information

Conditions

Myelopathy Cervical Bone Diseases Cervical Spondylosis With Myelopathy Kyphosis Post Surgical Musculoskeletal Diseases Neck Pain Neurologic Manifestations Ossification of Posterior Longitudinal Ligament Ossification, Heterotopic Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C3 laminectomy

Procedure

C3 laminectomy preserving semispinalis cervicis inserted into the axis.

C3 laminoplasty

Procedure

Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.

Primary outcomes

  1. C2-C7 Lordosis

    Time frame: 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.

  2. the Neck Disability Index (NDI)

    Time frame: 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 outcomes

  1. C2-C3 Lordosis

    Time frame: 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.

  2. C4-C7 Lordosis

    Time frame: 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.

  3. Cervical Sagittal Vertical Axis (cSVA)

    Time frame: 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.

  4. T1 Slope

    Time frame: 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.

  5. T1 Slope Minus Cervical Lordosis

    Time frame: 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.

  6. C2-C3 Interlaminar Spontaneous Fusion

    Time frame: at 2 year

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

  7. EuroQol Five-dimensional Questionnaire (EQ-5D) Scores

    Time frame: 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).

  8. Posterior Neck With Numering Rating Scale (NRS-N)

    Time frame: 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.

  9. Upper Limb Pain With Numering Rating Scale (NRS-L)

    Time frame: 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.

  10. Estimated Intraoperative Blood Loss

    Time frame: Intraoperative

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

  11. Operative Time

    Time frame: Intraoperative

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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