Status:
ENROLLING_BY_INVITATION
CONDUIT vs. PEEK Cages
Lead Sponsor:
University of Pennsylvania
Conditions:
Lumbar Degenerative Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
In this study, the Principal Investigator aim to compare the clinical and radiographic outcomes of patients with degenerative lumbar disease undergoing direct lateral interbody fusion (DLIF) using two...
Detailed Description
Direct lateral interbody fusion (DLIF) is a powerful surgical tool in a spine surgeon's armamentarium to address lumbar spine pathology minimally invasively. It has been widely adopted amongst spine s...
Eligibility Criteria
Inclusion
- • Patients with one to two consecutive level lumbar degenerative disease from L2to S1, including Grade 1 (\<25%) Spondylolisthesis
- Patients undergoing direct lateral interbody fusion (transpsoas or anterior-to-psoas approach) for lumbar disease
- Skeletally mature patients, aged 18 and older
- Patients able to fully comply with the clinical protocol and adhere to the follow-up schedule and protocol requirements
- Patients able to understand and sign the study-specific, IRB approved informed consent form
Exclusion
- • Spondylolisthesis greater than Grade 1
- Traumatic lumbar disease
- Spinal Deformity
- Coronal Cobb angle greater than 40 degrees
- Severe sagittal imbalance
- Existing fusion construct longer than 2 consecutive levels
- Active infection - systemic or local
- Tumor diagnosis
- Untreated osteoporosis, defined as T Spine \< -2.5 on DEXA scan
- Active smoking habit
- Current incarceration
- Pregnancy
- Involvement in an active spinal litigation
Key Trial Info
Start Date :
March 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06904898
Start Date
March 13 2021
End Date
March 31 2026
Last Update
April 1 2025
Active Locations (1)
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1
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107