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

NCT ID: NCT05003219

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-06-01

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.

Conditions

Cervical Myelopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ERAS group

patients received posterior cervical open-door laminoplasty under ERAS mode

No interventions assigned to this group

Conventional group

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

No interventions assigned to this group

Eligibility Criteria

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

• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

LM2021009

Identifier Type: -

Identifier Source: org_study_id