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Completed

NCT Number: NCT05001685

Study on the Postoperative Complications and Changes in Posterior Cervical Muscle Volume After Cervical Single Open-door Expansive Laminoplasty With Preservation of Muscular Ligament Complex

In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

Expansive laminoplasty of posterior cervical canal has been widely used for the treatment of cervical spondylotic myelopathy with cervical spinal stenosis and ossification of the posterior longitudinal ligament since Hirabayashi et al. described it in the 1970s. Traditional single-door surgery requires extensive dissection of both paravertebral muscles and ligaments, and resect part of the spinous process. Postoperative complications (axial neck pain, stiffness, cervical kyphosis, reduced range of motion, etc.) are also related to that in degree. In order to reduce the damage to the posterior cervical structure and reduce the associated complications, in the 1990s, Yoshihiko Oshima et al. introduced the expansive laminoplasty of the spinal canal with one side of the posterior ligamentwith muscle complex attached to the spinous process. In 2006, our hospital improved and began to use cervical expansive open-door laminoplasty preserving the unilateral ligament with muscle complex.The effect of recent follow-up, postoperative complications and their effects on posterior cervical muscle volume were also studied.However, there are few reports about medium and long-term follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • From 2006 to 2018, the patients admitted to the orthopedic department of our hospital for posterior cervical open-door expansive spinal canal laminoplasty with one side muscle-ligament complex reserved.Complete preoperative and postoperative diagnosis and treatment data of our hospital were available, and the follow-up time was ≥2 years.

Exclusion criteria

  • Patients with incomplete preoperative and postoperative diagnosis and treatment data or less than 2 years of follow-up

Treatment and study plan

Primary outcomes

  1. Posterior Cervical Muscle Volume

    Time frame: preoperation

    the volume of Posterior Cervical Muscle

  2. Posterior Cervical Muscle Volume

    Time frame: 2 years after operation

    the volume of Posterior Cervical Muscle

  3. C5 palsy

    Time frame: 2 years after operation

    C5 nerve palsy

  4. axial syndrome

    Time frame: 2 years after operation

    axial syndrome

  5. reoperation

    Time frame: 2 years after operation

    reoperation

  6. door closing

    Time frame: 2 years after operation

    door closing

Secondary outcomes

  1. mJOA

    Time frame: 2 years after operation

    modified Japanese orthopaedics association

  2. NDI

    Time frame: 2 years after operation

    neck disability index

  3. VAS

    Time frame: 2 years after operation

    visual analogue scale

  4. ROM

    Time frame: 2 years after operation

    range of motion

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Aug 12, 2021

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

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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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