Cervical MyelopathyNCT05003219
Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex
An observational study of Cervical Myelopathy, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Myelopathy
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Jun 2021
- 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 Any age
- Child, Adult, Older adult
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
Who may be able to join
- 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；
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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
Read the 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
- Keywords
- Open Door Laminoplasty, Preservation of Unilateral Muscular Ligament Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
mJOA
Modified Japanese Orthopaedic Association score
Measured: 2 years after operation
neck and shoulder VAS
neck and shoulder visual analogue score
Measured: 2 years after operation
NDI
neck disability index
Measured: 2 years after operation
AS
axial syndrome
Measured: 2 years after operation
C5 palsy
C5 palsy after operation
Measured: 2 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Aug 2019
- Primary completion31 Aug 2020
- Study completion1 Jun 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003219
- Sponsor's protocol ID
- LM2021009
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex
- ClinicalTrials.gov ID
- NCT05003219
- Acronym / sponsor ID
- LM2021009
- Conditions
- Cervical Myelopathy
- Keywords
- Open Door Laminoplasty, Preservation of Unilateral Muscular Ligament Complex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 12 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mJOA
Time frame: 2 years after operation
Modified Japanese Orthopaedic Association score
neck and shoulder VAS
Time frame: 2 years after operation
neck and shoulder visual analogue score
NDI
Time frame: 2 years after operation
neck disability index
AS
Time frame: 2 years after operation
axial syndrome
C5 palsy
Time frame: 2 years after operation
C5 palsy after operation
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 12 Aug 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 4 inclusion and 9 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 12 Aug 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?
mJOA (time frame: 2 years after operation). The study lists 5 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 12 Aug 2021.