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

Completed

• Conditions: Cervical Myelopathy

• Registration Number: NCT05003219
• Lead Sponsor: Peking University Third Hospital

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

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 Timeline

• Study Start: 2019-08-01
• Primary Completion: 2020-08-31
• Status Verified: 2021-06
• Study Completion: 2021-06-01
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 400

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；

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mJOA	2 years after operation	Modified Japanese Orthopaedic Association score
NDI	2 years after operation	neck disability index
AS	2 years after operation	axial syndrome
C5 palsy	2 years after operation	C5 palsy after operation
neck and shoulder VAS	2 years after operation	neck and shoulder visual analogue score

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China