Spinal Fusion Cages for Degenerative Disc Disease

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Spondylolisthesis, Spinal deformity, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best support for individuals with degenerative disc disease in the lower back undergoing direct lateral interbody fusion (DLIF) surgery. The study compares two types of cages used during surgery: PEEK cages with a growth protein (rhBMP-2) and CONDUIT cages, to determine which is more effective for recovery and results. Individuals with lower back issues between spine levels L2 to S1 who are scheduled for this surgery may be suitable candidates. The goal is to improve future surgeries and patient outcomes by determining the most effective cage type. As an unphased trial, this study allows participants to contribute to pioneering research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that these spinal fusion cages are safe for degenerative disc disease?

Research has shown that using cages for spinal fusion, such as the CONDUIT cages, is generally safe. A study on titanium cage implants, including the CONDUIT cages, found good early results on X-rays without major safety concerns. Another study on patients with back issues, including degenerative disc disease, demonstrated a strong safety record for these cages. No significant differences in unwanted effects have been observed compared to other methods.

For the PEEK cages with rhBMP-2, the rhBMP-2 (a protein that aids bone healing) has already received FDA approval for other uses, indicating a reasonable safety profile. While both treatments are being compared in this trial, existing data supports their well-tolerated and safe use in spinal fusion surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The CONDUIT cages are unique because they aim to improve spinal fusion outcomes for people with degenerative disc disease by using a novel design compared to traditional PEEK cages. Researchers are excited because these cages could offer better integration with bone, potentially leading to stronger and quicker spinal fusion. Unlike the standard PEEK cages combined with rhBMP-2, which rely on a growth factor for bone development, CONDUIT cages focus on enhancing the structural and biological environment for natural bone growth. This approach could not only improve patient recovery times but also reduce overall treatment costs.

What evidence suggests that this trial's treatments could be effective for degenerative disc disease?

Research has shown that CONDUIT cages, made from 3D-printed titanium, are promising in spinal surgeries. They maintain the space between spinal discs and support the joining of bones in the spine, which is crucial for treating conditions like degenerative disc disease. Studies have found that these cages often outperform traditional PEEK cages in aiding bone fusion and reducing the risk of sinking or settling. In this trial, some participants will receive CONDUIT cages.

Other participants will receive PEEK cages with rhBMP-2, a protein that promotes bone growth, to support spinal fusion. Previous patients have demonstrated that PEEK cages with rhBMP-2 can effectively enhance bone healing and stability in the spine. Both treatments aim to improve outcomes for patients undergoing spinal fusion surgery, but current findings suggest that CONDUIT cages might offer advantages in aiding bone fusion and providing structural support. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with degenerative lumbar disease who are candidates for a surgical procedure called direct lateral interbody fusion (DLIF). Specific eligibility criteria details were not provided.

Inclusion Criteria

I am having spine surgery through a side approach for lower back issues.

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 Criteria

I have been diagnosed with a tumor.

Active smoking habit

My spine condition is more severe than a slight misalignment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo direct lateral interbody fusion (DLIF) using either PEEK cages with rhBMP-2 or CONDUIT cages

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for clinical outcomes, fusion rates, and ODI scores

24 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• CONDUIT Cages

Trial Overview The study compares two types of cages used in DLIF surgery: PEEK cages with rhBMP-2 versus CONDUIT cages. It's randomized and open-label, meaning participants know which treatment they receive, to see if one type is more effective.

How Is the Trial Designed?

Group I: PEEK + rh-BMP-2 cage Experimental Treatment 1 Intervention

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.

Group II: Conduit Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study of 138 patients undergoing anterior cervical fusion with cylindrical cages, significant radiologic changes were observed over a mean follow-up of 38.61 months, including high rates of cage subsidence and osteophyte formation, particularly in the anterior portion.

Despite these changes, severe neurological complications were not reported, suggesting that while cylindrical cages can lead to structural changes, they may still be safe when used in carefully selected cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up radiologic and clinical evaluation of cylindrical cage for anterior interbody fusion in degenerative cervical disc disease. Kim, S., Chun, HJ., Yi, HJ., et al.[2021]

A review of nine peer-reviewed studies and five FDA summary reports found that both cervical total disk replacement and fusion have excellent safety profiles, with no significant differences in adverse event rates between the two treatments.

The analysis revealed that adverse event reporting in peer-reviewed literature is often inadequate, highlighting the need for improved documentation practices compared to the more comprehensive but less clinically applicable FDA summaries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events recording and reporting in clinical trials of cervical total disk replacement. Anderson, PA., Hart, RA.[2022]

Citations

1. carilionclinic.org carilionclinic.org/research/neurosurgery/Spine-Registry

Spine Clinical Registry This research registry is focused on gathering data on patients who have undergone surgery for degenerative disc disease and back pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227133/

Initial Radiographic Outcomes of Titanium Cage Implants in ... This retrospective study aims to evaluate the early radiological outcomes of the CONDUITTM EIT Cellular Titanium Cervical Cages in ACDF ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06704919?term=AREA%5BConditionSearch%5D(radiographic%20anatomic)&rank=7

NCT06704919 | Conduit Cages and Fibergraft BG Putty The Conduit cages are intended to restore the intervertebral height and to facilitate the intervertebral body fusion in the cervical and lumbar spine in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0303846725000149

3D printed titanium banana interbody cages versus ... 3DPT interbody cages outperformed PEEK interbody cages for TLIF according to fusion and subsidence rates at one year. 3DPT increased anterior and middle disc ...

5. app.trialscreen.org app.trialscreen.org/trials/conduit-anterior-lumbar-interbody-fusion-alif-cage-system-degenerative-study-nct06940453

CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage ... Participation in this study may provide benefits to future patients by helping to evaluate the safety and effectiveness of the CONDUIT ALIF Cage System, a novel ...

6. dovepress.com dovepress.com/evaluation-of-healthcare-outcomes-of-patients-treated-with-3d-printed--peer-reviewed-fulltext-article-MDER

Evaluation of healthcare outcomes of patients treated with ... Clinical characteristics collected at index included preoperative pathologies: degenerative disc disease (DDD), stenosis, back pain, instability ...

7. withpower.com withpower.com/trial/phase-lumbar-degenerative-disease-2-2021-f835d

Spinal Fusion Cages for Degenerative Disc Disease Research shows that spinal fusion using cages, including cervical fusion, generally has excellent safety records with no significant differences in adverse ...