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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment CONDUIT Cages for degenerative disc disease?

Research shows that using interbody fusion devices, like cages, in spinal fusion surgeries for degenerative disc disease can lead to significant improvements. In one study, 88.68% of patients had satisfactory outcomes, indicating that these devices help maintain space between vertebrae and promote fusion, reducing pain and disability. ^{1 2 3 4 5}

Is spinal fusion using cages safe for humans?

Research shows that spinal fusion using cages, including cervical fusion, generally has excellent safety records with no significant differences in adverse events compared to other treatments. However, rare complications like vertebral fractures can occur, as seen in a case with a zero-profile cage. ^{6 7 8 9 10}

How is the CONDUIT Cage treatment different from other treatments for degenerative disc disease?

The CONDUIT Cages are unique because they are designed to improve bone integration and reduce complications like subsidence (sinking) and migration (movement) compared to traditional PEEK cages, which often face these issues due to fibrous tissue formation around them. ^{1 3 5 9 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Bangladesh pubmed.ncbi.nlm.nih.gov

Instrumented posterior lumbar interbody fusion (PLIF) with interbody fusion device (Cage) in degenerative disc disease (DDD): 3 years outcome. [2016]

2. Austria pubmed.ncbi.nlm.nih.gov

Rationale for interbody fusion with threaded titanium cages at cervical and lumbar levels. Results on 357 cases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Asfora Bullet Cage System Shows Comparable Fusion Rate Success Versus Control Cage in Posterior Lumbar Interbody Fusion in a Randomized Clinical Trial. [2016]

4. France pubmed.ncbi.nlm.nih.gov

[Lumbar interbody fusion with threaded titanium cages. Results on 222 cases]. [2016]

5. Austria pubmed.ncbi.nlm.nih.gov

Anterior cervical fusion with polyetheretherketone (PEEK) cages in the treatment of degenerative disc disease. Preliminary observations in 36 consecutive cases with a minimum 12-month follow-up. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events recording and reporting in clinical trials of cervical total disk replacement. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Blade-Related Vertebral Fracture After Anterior Cervical Discectomy and Fusion with a Zero-Profile Cage: A Case Report. [2023]

9. Korea (South) 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Outcome Evaluation of Zero-Profile Device Used for Single-Level Anterior Cervical Discectomy and Fusion with Osteoporosis Compared without Osteoporosis: A Minimum Three-Year Follow-Up Study. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. [2021]