Degenerative DiseaseNCT04133103
Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
A study testing first ambulation at 4 hour after operation in people with Degenerative Disease and Fracture, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disease, Fracture
- What is being tested?
- first ambulation at 4 hour after operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2019to 2 Mar 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of degenerative diseases or spinal fracture
- single level instrumentation sugery
- sign informed consent
Who cannot join
- multilevel instrumentaion surgery
- diagnosis of severe osteoperosis (BMD < 60mg/cm3) by QCT
- coagulant function abnormality
- severe internal disease
- not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
Wei Tian, MD contact
China1 site, 1 recruiting
- Recruiting
Wei Tian
Beijing, 100035
Wei Tian, tianwei2019@yeah.net
About this study
Official title: A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.
- Conditions
- Degenerative Disease, Fracture
- Being tested
- first ambulation at 4 hour after operation
- Keywords
- early mobilisation, robot, spine, enhanced recovery
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first ambulation at 4 hour after operationProcedure or surgery
Two groups were conducted for first ambulation at 4 or 24 hours aftër operation
| Study group | Role | What they receive |
|---|---|---|
| First ambulation at 24 hours after operation | No intervention | Not described |
| First ambulation at 4 hours after operation | Experimental | Not described Receives: Procedure: first ambulation at 4 hour after operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Measured: preoperative
Visual Analogue Scale
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Measured: 4 hours postoperatively
Visual Analogue Scale
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Measured: 24 hours postoperatively
Visual Analogue Scale
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Measured: 3 months postoepratively
Secondary outcomes (4)
Japanese Orthopedic Association
The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = [(post-treatment score - pre-treatment score) / (29 - pre-treatment score)] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor.
Measured: preoperative
Japanese Orthopedic Association
The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = [(post-treatment score - pre-treatment score) / (29 - pre-treatment score)] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor.
Measured: 3 months postoperatively
Oswestry Disability Index
The Oswestry Disability Index is one of the principal condition-specific outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: [total score / (5 × number of questions answered)] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms.
Measured: preoperative
Oswestry Disability Index
The Oswestry Disability Index is one of the principal condition-specific outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: [total score / (5 × number of questions answered)] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start16 Oct 2019
- Primary completion31 Jan 2020 (estimated)
- Study completion2 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Tian, Beijing Jishuitan Hospital
- Investigators
- Wei Tian, Study director, Beijng Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133103
- Sponsor's protocol ID
- Jilunke201909-24
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- 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 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
- ClinicalTrials.gov ID
- NCT04133103
- Acronym / sponsor ID
- Jilunke201909-24
- Conditions
- Degenerative Disease, Fracture
- Keywords
- early mobilisation, robot, spine, enhanced recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 2 Mar 2020 (estimated)
- First posted
- 21 Oct 2019 (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.
In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First ambulation at 24 hours after operation | No intervention | – |
| First ambulation at 4 hours after operation | Experimental | Procedure: first ambulation at 4 hour after operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of degenerative diseases or spinal fracture
- single level instrumentation sugery
- sign informed consent
Key exclusion criteria (5 listed)
- multilevel instrumentaion surgery
- diagnosis of severe osteoperosis (BMD < 60mg/cm3) by QCT
- coagulant function abnormality
- severe internal disease
- not suitable for inclusion
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 |
|---|---|---|
| first ambulation at 4 hour after operationTwo groups were conducted for first ambulation at 4 or 24 hours aftër operation | Procedure or surgery | First ambulation at 4 hours after operation |
Primary outcome
Visual Analogue Scale
Time frame: preoperative
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Visual Analogue Scale
Time frame: 4 hours postoperatively
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Visual Analogue Scale
Time frame: 24 hours postoperatively
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
Visual Analogue Scale
Time frame: 3 months postoepratively
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
4 secondary outcomes
Japanese Orthopedic Association
Time frame: preoperative
Japanese Orthopedic Association
Time frame: 3 months postoperatively
Oswestry Disability Index
Time frame: preoperative
Oswestry Disability Index
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- 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.
Wei Tian, MD contact
Wei Tian study director
Beijng Jishuitan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first ambulation at 4 hour after operation in people with Degenerative Disease and Fracture, run by Beijing Jishuitan 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Tian, MD (tianwei2019@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: preoperative). The study lists 4 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 11 Dec 2019.