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

Cervical Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003219
• Other study ID #: LM2021009
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Cervical Myelopathy
• Spinal Cord Diseases

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