Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease

Launched by XUANWU HOSPITAL, BEIJING · Sep 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a surgical procedure called interbody fusion, which is used to treat problems in the lower back caused by degenerative disc disease. Specifically, the study aims to see how effective extending the fusion to one more level of the spine is for patients who have vacuum signs in their adjacent discs but are not experiencing any symptoms. This could help doctors understand if this approach offers better results for patients with back issues.

To participate in the trial, individuals must be between 18 and 60 years old and have specific back problems that require surgery involving 1 or 2 segments of their spine. They should also be willing to follow up with the doctors after the surgery and sign an agreement to participate. However, certain people will not be eligible, including those with serious health issues like liver or kidney problems, pregnant women, or those who have participated in other trials recently. If you join, you can expect to undergo the surgical procedure and participate in follow-up visits to monitor your recovery and outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The age was between 18-60 years old; patients with lumbar degeneration required 1-2 segment interbody fusion, and there were vacuum signs but no symptoms and no instability of the discs in the adjacent segments (power position slip ≤3mm and segmental angle change ≤10°); they agreed with the surgical plan and were willing to undergo long-term clinical follow-up, and signed an informed consent form.
• Exclusion Criteria:
• • Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.