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

P

Peking University

Status

Completed

Conditions

Cervical Myelopathy

Study type

Observational

Funder types

Other

Identifiers

NCT05003219
LM2021009

Details and patient eligibility

About

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

Full 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.

Enrollment

400 patients

Sex

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

ERAS group
Description:
patients received posterior cervical open-door laminoplasty under ERAS mode
Conventional group
Description:
patients received posterior cervical open-door laminoplasty under routine perioperative management mode

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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