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

NCT05003219 | Completed

• 1 other identifier: LM2021009
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Myelopathy

Keywords

Open Door Laminoplasty; Preservation of Unilateral Muscular Ligament Complex

Outcome Measures

Primary Outcomes (5)

• mJOA

  Modified Japanese Orthopaedic Association score

  2 years after operation

• neck and shoulder VAS

  neck and shoulder visual analogue score

  2 years after operation

• NDI

  neck disability index

  2 years after operation

• AS

  axial syndrome

  2 years after operation

• C5 palsy

  C5 palsy after operation

  2 years after operation

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18-70, gender unlimited;
• The patient was diagnosed with cervical spondylosis and met the indications of posterior cervical laminoplasty;
• Basis of serious diseases of heart, brain, lung, kidney or other important organs, preoperative ASA score I-II;
• Agree to participate in the study and sign the informed consent；

You may not qualify if:

• Preoperative ASA score ≥III;
• One-stage combined anterior and posterior surgery of cervical spine;
• Correction of cervical deformity;
• 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;
• Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;
• People with mental disorders, alcohol dependence or drug abuse history;
• women in the period of lactation and pregnancy;
• People with allergic constitution or previous allergies to a variety of drugs;
• Other researchers consider it inappropriate to participate in this study

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 12, 2021
• Study Start: August 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: June 1, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)