P-15L Bone Graft for Degenerative Disc Disease

Recruiting at 34 trial locations

Overseen By John O'Toole, M.D., M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CeraPedics, Inc

Disqualifiers: Osteoporosis, Osteopenia, Osteomalacia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

290 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if the P-15L bone graft is as safe and effective as traditional methods for helping bones heal in back surgery patients with degenerative disc disease. It focuses on patients who smoke, are obese, or have diabetes because these conditions can make bone healing harder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the P-15L Bone Graft treatment for Degenerative Disc Disease?

The research indicates that using bone grafts in spinal fusion surgeries, like the P-15L Bone Graft, can be effective for treating degenerative disc disease, as shown by high fusion rates and reduced pain in patients. Similar treatments have demonstrated positive outcomes in terms of pain relief and improved quality of life. ^{1 2 3 4 5}

How is the P-15L Bone Graft treatment different from other treatments for degenerative disc disease?

The P-15L Bone Graft is unique because it uses a biomimetic approach, combining a synthetic peptide (P-15) that mimics the cell-binding site of Type-I collagen with a bovine-derived matrix to promote bone growth, offering an alternative to traditional bone grafts. This method provides a scaffold for bone-forming cells, potentially leading to effective spinal fusion without the need for harvesting bone from the patient's own body. ^{6 7 8 9 10}

Eligibility Criteria

Adults aged 22-80 with degenerative disc disease causing back and leg pain, who have not had previous spinal fusion at the affected level (between L2 and S1) can join. They must score ≥35 on a specific back pain questionnaire. Those with significant metabolic diseases affecting bone growth, active cancer, or needing multiple-level fusions are excluded.

Inclusion Criteria

Oswestry Low Back Pain Disability Questionnaire score of ≥ 35

I am between 22 and 80 years old.

I have back pain that spreads to my legs, confirmed by a doctor.

Exclusion Criteria

I have had surgery on my spine before.

My doctor thinks I have a bone condition that could affect bone growth.

I currently have cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transforaminal lumbar interbody fusion (TLIF) with either P-15L Bone Graft or local autologous bone

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness, including assessment of Oswestry Disability Index, neurological status, and fusion achievement

24 months

Treatment Details

Interventions

• P-15L Bone Graft

Trial Overview The trial is testing if P-15L Bone Graft is as effective and safe as local autologous bone for use in spinal fusion surgery (TLIF) with instrumentation in patients with degenerative disc disease. It will also look closely at results in high-risk groups like smokers, obese individuals, and diabetics.

Participant Groups

Group I: P-15L Bone Graft Experimental Treatment 1 Intervention

The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF

Group II: Local autologous bone Active Control 1 Intervention

The active control group will be treated with local autologous bone in an instrumented TLIF

Who Is Running the Clinical Trial?

CeraPedics, Inc

Lead Sponsor

Trials

6

Recruited

1,400+

Findings from Research

From 2000 to 2009, surgical treatments for lumbar degenerative disc disease (DDD) in the U.S. increased significantly, with a 2.4-fold rise in procedures performed, indicating a growing reliance on surgical options for this condition.

Among the types of surgeries, anterior and posterior lumbar fusion procedures saw the most substantial increases, while total disc replacement (TDR) remained relatively stable, suggesting that traditional fusion methods are preferred over TDR in the current treatment landscape.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. Yoshihara, H., Yoneoka, D.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

[The long-term results of decompression and anterior lumbar interbody fusion for the treatment of degenerative lumbar spondylolisthesis]. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Quality and Quantity of Published Studies Evaluating Lumbar Fusion during the Past 10 Years: A Systematic Review. [2020]

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

Bone Graft Substitutes in Single- or Double-Level Anterior Cervical Discectomy and Fusion: A Systematic Review. [2021]

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

Clinical outcomes of lumbar degenerative disc disease treated with posterior lumbar interbody fusion allograft spacer: a prospective, multicenter trial with 2-year follow-up. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Impact of surgery on pain, disability, and quality of life of patients with degenerative lumbar disease: Brazilian data. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous cement discoplasty for the treatment of advanced degenerative disk disease in elderly patients. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Posterior dynamic stabilization in the treatment of lumbar degenerative disc disease: 2-year follow-up. [2019]

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

National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of ABM/P-15 versus autogenous bone in an ovine lumbar interbody fusion model. [2021]

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

Analysis of circumferential lumbar fusion outcome in the treatment of degenerative disc disease of the lumbar spine. [2016]