Lumbar Disk HerniationNCT06591442
Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
An observational study of Lumbar Disk Herniation and Lumbar Spinal Stenosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lumbar Disk Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
- What is being tested?
- This is an observational study
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 3 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Orthopedics, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, China
Who may be able to join
- Informed consent signed and dated by subject or guardian
- Commit to follow the research procedures and cooperate with the whole process of the study
- The subjects are 60 years old or older, regardless of gender
- Patients with degenerative spinal diseases requiring spinal fusion surgery
- Generally in good physical condition
- Able to adhere to and cooperate with research interventions, such as oral medication
- In fertile women, contraception should be used for at least one month prior to screening, and they should commit to use contraception throughout the study period and continue until the specified time after the study
Who cannot join
- Acute infection
- Congenital malformation
- Abnormal anatomy or skeletal variation
- Malignant tumor
- The surgical area was locally infected with symptoms of local inflammation
- Fever or leukocytosis
Show all 12Show fewer
- Morbid obesity
- Pregnant and nursing women
- Mental illness
- Acute joint disease, bone resorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this condition may limit the degree of correction that can be produced, the amount of mechanical fixation, and/or the quality of the bone graft
- Patients who are unwilling to cooperate with post-operative treatment
- Any time an implant is performed it interferes with the anatomy or intended physiological function of the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Orthopedics, Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430023
Wuhan, Hubei, 430023
About this study
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.
Read the detailed description
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in elderly patients: a prospective cohort study
- Conditions
- Lumbar Disk Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Cervical Spondylotic Myelopathy, Cervical Radiculopathy
- Being tested
- This is an observational study
- Keywords
- Enhanced recovery after surgery (ERAS), Spinal fusion surgery, Advanced age patient, High risk factors
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis, Spondylolisthesis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyDiagnostic test
This study divides the elderly population into two groups: the Elderly group and the Advanced age group. By observing the enhanced recovery after spinal fusion surgery in these two distinct age groups of elderly patients, risk factors affecting postoperative enhanced recovery will be identified. Detection index: Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction), Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) pain score. The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0.
| Study group | Role | What they receive |
|---|---|---|
| Elderly group patients (60-74 years). | Not described Receives: Diagnostic Test: This is an observational study | |
| Advanced age group patients (≥75 years) | Not described Receives: Diagnostic Test: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery
Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction). The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0.
Measured: Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2024
- Primary completion3 Sep 2027 (estimated)
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disk HerniationStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caoyang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591442
- Sponsor's protocol ID
- UHCT-IEC-SOP-016-03-01-2024-1
- Other IDs
- 2024(0735)
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
- ClinicalTrials.gov ID
- NCT06591442
- Acronym / sponsor ID
- UHCT-IEC-SOP-016-03-01-2024-1
- Conditions
- Lumbar Disk Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Cervical Spondylotic Myelopathy, Cervical Radiculopathy
- Keywords
- Enhanced recovery after surgery (ERAS), Spinal fusion surgery, Advanced age patient, High risk factors
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 3 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (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 determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.
Detailed description
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in elderly patients: a prospective cohort study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly group patients (60-74 years). | – | Diagnostic Test: This is an observational study |
| Advanced age group patients (≥75 years) | – | Diagnostic Test: This is an observational study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Orthopedics, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, China
Key inclusion criteria (7 listed)
- Informed consent signed and dated by subject or guardian
- Commit to follow the research procedures and cooperate with the whole process of the study
- The subjects are 60 years old or older, regardless of gender
- Patients with degenerative spinal diseases requiring spinal fusion surgery
- Generally in good physical condition
Key exclusion criteria (12 listed)
- Acute infection
- Congenital malformation
- Abnormal anatomy or skeletal variation
- Malignant tumor
- The surgical area was locally infected with symptoms of local inflammation
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 |
|---|---|---|
| This is an observational studyThis study divides the elderly population into two groups: the Elderly group and the Advanced age group. By observing the enhanced recovery after spinal fusion surgery in these two distinct age groups of elderly patients, risk factors affecting postoperative enhanced recovery will be identified. Detection index: Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction), Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) pain score. The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0. | Diagnostic test | Advanced age group patients (≥75 years), Elderly group patients (60-74 years). |
Primary outcome
Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery
Time frame: Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery
Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction). The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Lumbar Disk Herniation
Recruiting
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Disc Herniation, Disk Herniated Lumbar
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.
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 Lumbar Disk Herniation and Lumbar Spinal Stenosis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 7 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery (time frame: Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery). 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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.