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

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

Study Overview

• Status: Completed
• Conditions: Cervical Myelopathy

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Between August 2020 and December 2021, patients receiving conventional cervical posterior open-door laminoplasty due to cervical myelopathy or ossification of the posterior longitudinal ligament of the cervical spine

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ERAS group; patients received posterior cervical open-door laminoplasty under ERAS mode
Conventional group; patients received posterior cervical open-door laminoplasty under routine perioperative management mode

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (ACTUAL): August 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Open Door Laminoplasty; Preservation of Unilateral Muscular Ligament Complex
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: LM2021009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No