Cervical MyelopathyNCT04947891
The Establishment of the Integration of Surgery and Postoperative Intensive Recovery of Patients With CSM
An observational study of Cervical Myelopathy and Ossification of Posterior Longitudinal Ligament in Cervical Region, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management for CSM or OPLL patients, and verify its safety, practicability and reliability. Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Cervical Myelopathy, Ossification of Posterior Longitudinal Ligament in Cervical Region
- What is being tested?
- Intensive recovery management
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2017to 20 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty
Who may be able to join
- (1) Age: 18~70 years. (2) Diagnosed as CSM or OPLL. (3) Going to receive C3-C7 open-door laminoplasty. (4) Agree to join this study and sign the informed consent.
Who cannot join
- (1) Anterior and posterior combined surgery. (2) Posterior laminoplasty combined fusion. (3) Severe osteoporosis. (4) Morbid obesity. (5) patients with mental disorder. (6) patients with previous history of cervical spine surgery. (7) Abnormal laboratory report of liver function, kidney function and hematologic system.(8) Poor compliance. (9) Patients with other surgical contraindications. (10) Patients with intemperance or taking drugs. (11) Patients who joined other study within the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Establishment of the Integration of Posterior Approach Surgical Treatment and Postoperative Intensive Recovery Management of Patients With Degenerative Cervical Spine Myelopathy
This study aims to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management for CSM or OPLL patients, and verify its safety, practicability and reliability.
Read the detailed description
In order to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management, and verify its safety, practicability and reliability, this study enrolled 130 patients with CSM or OPLL undergoing C3-7 open-door laminoplasty. Patients are divided in two groups randomly. The study group has 80 patients, treated with postoperative intensive recovery management, and the control group has 50 patients. The data is collected preoperatively, at 3-month follow-up and 1-year follow-up.
- Being tested
- Intensive recovery management
- Keywords
- Cervical myelopathy, Ossification of posterior longitudinal ligament, Intensive recovery, Quality of life, Surgical outcomes
- Medical subject headings
- Ossification of Posterior Longitudinal Ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive recovery managementProcedure or surgery
Intensive recovery management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients will be treated with intensive recovery method after surgery. Receives: Procedure: Intensive recovery management | |
| Control group | Patients will be treated with regular recovery method after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical spine mechanical analysis
The ROM and multi-dimensional mechanical analysis of cervical spine before surgery, at 3-month postoperative follow-up and 1-year follow
Measured: Preoperation to 1 year after surgery.
Cervical spine functions
NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow
Measured: Preoperation to 1 year after surgery.
Secondary outcomes (3)
Outcome of quality of life
EQ-5D score before surgery, at 3-month postoperative follow-up and 1-year follow
Measured: Preoperation to 1 year after surgery.
Outcome of pain
VAS score before surgery, at 3-month postoperative follow-up and 1-year follow
Measured: Preoperation to 1 year after surgery.
Neurological outcome
mJOA score before surgery, at 3-month postoperative follow-up and 1-year follow
Measured: Preoperation to 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start6 Dec 2017
- Primary completion15 Jun 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feifei Zhou, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947891
- Sponsor's protocol ID
- M2017310
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of the Integration of Posterior Approach Surgical Treatment and Postoperative Intensive Recovery Management of Patients With Degenerative Cervical Spine Myelopathy
- ClinicalTrials.gov ID
- NCT04947891
- Acronym / sponsor ID
- M2017310
- Keywords
- Cervical myelopathy, Ossification of posterior longitudinal ligament, Intensive recovery, Quality of life, Surgical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management for CSM or OPLL patients, and verify its safety, practicability and reliability.
Detailed description
In order to establish the specialist consensus of the integration of posterior approach surgical treatment and postoperative intensive recovery management, and verify its safety, practicability and reliability, this study enrolled 130 patients with CSM or OPLL undergoing C3-7 open-door laminoplasty. Patients are divided in two groups randomly. The study group has 80 patients, treated with postoperative intensive recovery management, and the control group has 50 patients. The data is collected preoperatively, at 3-month follow-up and 1-year follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Intensive recovery managementPatients will be treated with intensive recovery method after surgery. |
| Control group | – | –Patients will be treated with regular recovery method after surgery. |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with degenerative CSM or OPLL undergoing C3-7 open-door laminoplasty
Key inclusion criteria (1 listed)
- (1) Age: 18~70 years. (2) Diagnosed as CSM or OPLL. (3) Going to receive C3-C7 open-door laminoplasty. (4) Agree to join this study and sign the informed consent.
Key exclusion criteria (1 listed)
- (1) Anterior and posterior combined surgery. (2) Posterior laminoplasty combined fusion. (3) Severe osteoporosis. (4) Morbid obesity. (5) patients with mental disorder. (6) patients with previous history of cervical spine surgery. (7) Abnormal laboratory report of liver function, kidney function and hematologic system.(8) Poor compliance. (9) Patients with other surgical contraindications. (10) Patients with intemperance or taking drugs. (11) Patients who joined other study within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive recovery managementIntensive recovery management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery. | Procedure or surgery | Study group |
Primary outcome
Cervical spine mechanical analysis
Time frame: Preoperation to 1 year after surgery.
The ROM and multi-dimensional mechanical analysis of cervical spine before surgery, at 3-month postoperative follow-up and 1-year follow
Cervical spine functions
Time frame: Preoperation to 1 year after surgery.
NDI score and JOACMEQ score before surgery, at 3-month postoperative follow-up and 1-year follow
3 secondary outcomes
Outcome of quality of life
Time frame: Preoperation to 1 year after surgery.
Outcome of pain
Time frame: Preoperation to 1 year after surgery.
Neurological outcome
Time frame: Preoperation to 1 year after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Cervical Myelopathy
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Stimulation-based Therapy to Improve Balance in DCM
Degenerative Cervical Myelopathy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feifei Zhou, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Myelopathy and Ossification of Posterior Longitudinal Ligament in Cervical Region, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical spine mechanical analysis (time frame: Preoperation to 1 year after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.