CONDUIT vs. PEEK Cages

NCT06904898 | Active Not Recruiting FDA Device

• 1 other identifier: 844964
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 different types of lateral interbody cages: PEEK cages combined with rhBMP-2 versus CONDUIT cages. This will be a randomized, prospective, open-label clinical trial. By examining these two groups, the PI hope to determine whether PEEK cages with rhBMP-2 and CONDUIT cages are equally effective for DLIF procedures. The findings from this study will help us optimize the surgical approach for future patients undergoing DLIF.

Conditions

Lumbar Degenerative Disease

Outcome Measures

Primary Outcomes (2)

• Clinical outcomes

  Difference in fusion rates for patients who get the PEEK + rh-BMP-2 cage and those who get the CONDUIT cage.

  24 months

• ODI scores

  The ODI is comprised of ten items with associated statements for the patient to select which reflect the patient's ability to manage their everyday life while dealing with their pain. Each of the ten items in the ODI has six statements from which patients are requested to select one. This allows scoring from 0-5 for each item. A maximum score of 50 is possible. The score obtained by individual patients can be multiplied by 2, and this will provide a percentage score

  24 months

Secondary Outcomes (1)

• Cost

  24 months

Study Arms (2)

Conduit

OTHER

Patients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost.

Device: Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage

PEEK + rh-BMP-2 cage

OTHER

Patients undergoing DLIf (transposons or anterior-to-psoas approach) will be randomized to PEEK cages + rhBMP-2 vs. CONDUIT cages to compare the clinical outcomes and determine the associated cost.

Device: Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage

Interventions

Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage DEVICE

Comparison between cages to determine the effectiveness and cost related to the study procedures.

Conduit; PEEK + rh-BMP-2 cage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study participants will be randomized to either receiving Cougar LS/Syncage ALIF or CONDUIT LLIF/ALIF cage at the time of surgery. utilizing GraphPad QuickCalcs, which is a closed-source, free, online limited randomization software for allocating subjects to a number of groups, with repeated block defaults at one. It can also produce a shuffled list of numbers for each group. After randomization, each patient will undergo DLIF using the standard surgical technique.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 1, 2025
• Study Start: March 13, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)