NCT04970862

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

July 2, 2021

Last Update Submit

July 11, 2021

Conditions

Adjacent Segment DiseaseAdjacent Segment Degeneration

Keywords

Adjacent Segment Degenerationreversion surgery

Outcome Measures

Primary Outcomes (3)

  • 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

  • Japanese Orthopedic Association (JOA) score

    Japanese Orthopedic Association (JOA) score

    2 years after revision surgery

  • Oswestry Disability Index (ODI)

    Oswestry Disability Index (ODI)

    2 years after revision surgery

Interventions

reversion surgeryPROCEDURE

reversion surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2010 to June 2018, patients with lumbar spine disease hospitalized in orthopedics were screened out to meet the criteria

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Weishi Li, M.D.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weishi Li, M.D.

CONTACT

(+86010)62017691-7011puh3liweishi@163.com

Zhuofu Li, M.D.

CONTACT

bjmulizhuofu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 21, 2021

Study Start

August 1, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share