Spinal Degenerative DiseasesNCT06665360
Identify the State of Laminae Milling by Sound
An observational study of Spinal Degenerative Diseases, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
After verifying the signals collected in the laboratory, the investigators performed a preliminary verification in the surgery, in which the sound pressure signals of lamina milling were collected during the surgery to identify milling status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Degenerative Diseases
- What is being tested?
- The high speed bur was used to mill the cancellous cortical bone of the lamina
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 29 Oct 2024
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with spinal stenosis requiring surgery
Who may be able to join
- 1. Patients with myelopathy caused by spinal stenosis who had undergone posterior decompression.
Who cannot join
- Receipt of surgery using an anterior approach or circumferential spinal cord decompression through a posterior approach;
- Experience of trauma;
- History of spinal tumor;
- Previous spinal surgery;
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: Sound Timbre-based Milling Status Identification in Robotic Vertebral Lamina Milling
After verifying the signals collected in the laboratory, the investigators performed a preliminary verification in the surgery, in which the sound pressure signals of lamina milling were collected during the surgery to identify milling status.
Read the detailed description
The sound of milling cortical bone and cancellous bone were recorded during posterior spinal decompression.
- Conditions
- Spinal Degenerative Diseases
- Being tested
- The high speed bur was used to mill the cancellous cortical bone of the lamina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The high speed bur was used to mill the cancellous cortical bone of the laminaOther
The high speed bur was used to mill the cancellous cortical bone of the lamina
| Study group | Role | What they receive |
|---|---|---|
| posterior spinal decompression | Not described Receives: Other: The high speed bur was used to mill the cancellous cortical bone of the lamina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of sound pressure
Measured: The sound pressure signals were collected during the operation in 6 cases, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Jul 2024
- Primary completion17 Aug 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Degenerative DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nankai University
- Responsible party
- Principal investigator, Rui Wang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665360
- Sponsor's protocol ID
- IRB2021-KY-198
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound Timbre-based Milling Status Identification in Robotic Vertebral Lamina Milling
- ClinicalTrials.gov ID
- NCT06665360
- Acronym / sponsor ID
- IRB2021-KY-198
- Conditions
- Spinal Degenerative Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Collaborators
- Nankai University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 30 Oct 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.
After verifying the signals collected in the laboratory, the investigators performed a preliminary verification in the surgery, in which the sound pressure signals of lamina milling were collected during the surgery to identify milling status.
Detailed description
The sound of milling cortical bone and cancellous bone were recorded during posterior spinal decompression.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| posterior spinal decompression | – | Other: The high speed bur was used to mill the cancellous cortical bone of the lamina |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with spinal stenosis requiring surgery
Key inclusion criteria (1 listed)
- 1. Patients with myelopathy caused by spinal stenosis who had undergone posterior decompression.
Key exclusion criteria (4 listed)
- Receipt of surgery using an anterior approach or circumferential spinal cord decompression through a posterior approach;
- Experience of trauma;
- History of spinal tumor;
- Previous spinal surgery;
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 |
|---|---|---|
| The high speed bur was used to mill the cancellous cortical bone of the laminaThe high speed bur was used to mill the cancellous cortical bone of the lamina | Other | posterior spinal decompression |
Primary outcome
Amplitude of sound pressure
Time frame: The sound pressure signals were collected during the operation in 6 cases, an average of 3 months
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 30 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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 Spinal Degenerative Diseases, run by Tianjin Medical University General 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 4 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 30 Oct 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?
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?
Amplitude of sound pressure (time frame: The sound pressure signals were collected during the operation in 6 cases, an average of 3 months). 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 30 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.