Identify the State of Laminae Milling by Sound

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.

Study Overview

• Status: Completed
• Conditions: Spinal Degenerative Diseases
• Intervention / Treatment: Other: The high speed bur was used to mill the cancellous cortical bone of the lamina

Detailed Description

The sound of milling cortical bone and cancellous bone were recorded during posterior spinal decompression.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal stenosis requiring surgery

Description

Inclusion Criteria:

1. Patients with myelopathy caused by spinal stenosis who had undergone posterior decompression.

Exclusion Criteria:

1. Receipt of surgery using an anterior approach or circumferential spinal cord decompression through a posterior approach;
2. Experience of trauma;
3. History of spinal tumor;
4. Previous spinal surgery;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
posterior spinal decompression	Other: The high speed bur was used to mill the cancellous cortical bone of the lamina; The high speed bur was used to mill the cancellous cortical bone of the lamina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amplitude of sound pressure	The sound pressure signals were collected during the operation in 6 cases, an average of 3 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Collaborators: Nankai University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): August 17, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB2021-KY-198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No