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OpenTrials
Completed

NCT Number: NCT05003219

Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex

To collect and measure the preoperative and postoperative clinical data of the patients undergoing single open-door expansive laminoplasty with preservation of musclar ligament complex through posterior cervical approach in our hospital and summarize the long-term clinical effect and postoperative imaging changes and analyze the long-term clinical effect of this operation

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Key information

Conditions

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

Objective: To collect and measure the preoperative and postoperative clinical data of the patients undergoing single open-door expansive laminoplasty with preservation of musclar ligament complex through posterior cervical approach in our hospital. To summarize the long-term clinical effect and postoperative imaging changes and to analyze the long-term clinical effect of this operation on cervical spondylosis. To provide scientific basis for clinical work and theoretical research in the future.

This study was a retrospective study, and the medical records of posterior cervical open-door expansive laminoplasty with musclar ligament complex preservation in the orthopedics department of our hospital from 2006 to 2017 were collected, and the patients with complete diagnosis and treatment data were selected for analysis and research.The preoperative and postoperative changes of the patients were studied by combining the patient's case and imaging examination (MR, CT, X plain film) and other diagnosis and treatment data.

Who can participate

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

Inclusion criteria

  • Age 18-70, gender unlimited;
  • The patient was diagnosed with cervical spondylosis and met the indications of posterior cervical laminoplasty;
  • Basis of serious diseases of heart, brain, lung, kidney or other important organs, preoperative ASA score I-II;
  • Agree to participate in the study and sign the informed consent;

Exclusion criteria

  • Preoperative ASA score ≥III;
  • One-stage combined anterior and posterior surgery of cervical spine;
  • Correction of cervical deformity;
  • Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations;
  • Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;
  • People with mental disorders, alcohol dependence or drug abuse history;
  • women in the period of lactation and pregnancy;
  • People with allergic constitution or previous allergies to a variety of drugs;
  • Other researchers consider it inappropriate to participate in this study

Treatment and study plan

Primary outcomes

  1. mJOA

    Time frame: 2 years after operation

    Modified Japanese Orthopaedic Association score

  2. neck and shoulder VAS

    Time frame: 2 years after operation

    neck and shoulder visual analogue score

  3. NDI

    Time frame: 2 years after operation

    neck disability index

  4. AS

    Time frame: 2 years after operation

    axial syndrome

  5. C5 palsy

    Time frame: 2 years after operation

    C5 palsy after operation

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.

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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