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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05003219
Other study ID # LM2021009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 1, 2021
Est. primary completion date August 31, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mJOA Modified Japanese Orthopaedic Association score 2 years after operation
Primary neck and shoulder VAS neck and shoulder visual analogue score 2 years after operation
Primary NDI neck disability index 2 years after operation
Primary AS axial syndrome 2 years after operation
Primary C5 palsy C5 palsy after operation 2 years after operation
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