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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05003219
Collaborator
(none)
400
Enrollment
1
Location
22
Actual Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex
    Actual Study Start Date :
    Aug 1, 2019
    Actual Primary Completion Date :
    Aug 31, 2020
    Actual Study Completion Date :
    Jun 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    ERAS group

    patients received posterior cervical open-door laminoplasty under ERAS mode
    Conventional group

    patients received posterior cervical open-door laminoplasty under routine perioperative management mode

    Outcome Measures

    Primary Outcome Measures

    1. mJOA [2 years after operation]

      Modified Japanese Orthopaedic Association score

    2. neck and shoulder VAS [2 years after operation]

      neck and shoulder visual analogue score

    3. NDI [2 years after operation]

      neck disability index

    4. AS [2 years after operation]

      axial syndrome

    5. C5 palsy [2 years after operation]

      C5 palsy after operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age 18-70, gender unlimited;

    2. The patient was diagnosed with cervical spondylosis and met the indications of posterior cervical laminoplasty;

    3. Basis of serious diseases of heart, brain, lung, kidney or other important organs, preoperative ASA score I-II;

    4. Agree to participate in the study and sign the informed consent；

    Exclusion Criteria:

    1. Preoperative ASA score ≥III;

    2. One-stage combined anterior and posterior surgery of cervical spine;

    3. Correction of cervical deformity;

    4. 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;

    5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;

    6. People with mental disorders, alcohol dependence or drug abuse history;

    7. women in the period of lactation and pregnancy;

    8. People with allergic constitution or previous allergies to a variety of drugs;

    9. Other researchers consider it inappropriate to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT05003219
    Other Study ID Numbers:
    • LM2021009
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Aug 12, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking University Third Hospital
    Open Door Laminoplasty
    Preservation of Unilateral Muscular Ligament Complex
    Additional relevant MeSH terms:
    Spinal Cord Diseases

    Study Results

    No Results Posted as of Aug 12, 2021