Clinical trial NCT05003219: Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex
Official title: Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Myelopathy
Keywords: Open Door Laminoplasty
Preservation of Unilateral Muscular Ligament Complex
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 400
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: mJOA
timeFrame: 2 years after operation
measure: neck and shoulder VAS
timeFrame: 2 years after operation
measure: NDI
timeFrame: 2 years after operation
measure: AS
timeFrame: 2 years after operation
measure: C5 palsy
timeFrame: 2 years after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: