Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration

Adjacent Segment Degeneration Clinical Trial

Official title:

Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04970862
• Other study ID #: M2020288
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Weishi Li, M.D.
• Phone: (+86010)62017691-7011
• Email: puh3liweishi[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• For patients undergoing revision surgery in adjacent segments due to S-ASD, the revision surgery is at least half a year from the first operation;

• X-ray, CT and MRI examination data of the anterior and lateral extension of the lumbar spine were available within 1 month before surgery and at the last follow-up;

• Follow-up for at least 2 years after revision;

Exclusion Criteria:

• Patients with history of congenital spinal deformity, spinal tumor, spinal tuberculosis.

Related Conditions & MeSH terms

• Adjacent Segment Degeneration
• Adjacent Segment Disease

Intervention

Procedure:
• reversion surgery
reversion surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) scores of low back pain and leg pain	Visual Analog Scale (VAS) scores of low back pain and leg pain	2 years after revision surgery
Primary	Japanese Orthopedic Association (JOA) score	Japanese Orthopedic Association (JOA) score	2 years after revision surgery
Primary	Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI)	2 years after revision surgery