What side effects are associated with this type of intervention?

Common treatments for Degenerative Disc Disease (DDD) that promote bone growth and healing, such as bone grafts and spinal fusion, can have several side effects. These may include infection, bleeding, nerve damage, and pain at the graft site. Additionally, there is a risk of non-union where the bone does not heal properly, leading to persistent pain and the potential need for additional surgery. Patients may also experience complications related to anesthesia and general surgical risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Degenerative Disc Disease that promote bone growth and healing. These include bone grafts and bone graft substitutes, such as autologous bone grafts and allografts. Additionally, treatments like teriparatide, a parathyroid hormone analog, have been used to enhance bone healing and fusion rates in spinal surgeries. Bisphosphonates, although primarily used for osteoporosis, have also been explored for their potential benefits in spinal fusion procedures. The investigational P-15L bone graft aims to provide an effective alternative by promoting bone growth and healing in patients with DDD.

What other types of research exist?

Promising novel alternatives to P-15L bone graft for DDD patients include: 1) Recombinant human bone morphogenetic proteins (rhBMPs), which have shown efficacy in promoting bone fusion and healing. 2) Calcium phosphate-based scaffolds, which provide a supportive structure for bone growth. 3) Autologous stem cell therapy, which uses the patient's own stem cells to enhance bone regeneration. 4) Advanced synthetic bone grafts, such as those incorporating bioactive glass or hydroxyapatite, which mimic natural bone properties and support healing. These alternatives have demonstrated potential in recent clinical trials and studies.

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Bone Graft

P-15L Bone Graft for Degenerative Disc Disease

N/A

Waitlist Available

Research Sponsored by CeraPedics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Skeletally mature adults between 22 and 80 years old (inclusive)

Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam

Must not have

Previous spinal instrumentation or a previous interbody fusion procedure at the involved level

Active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical surgical risks such as infection, bleeding, nerve damage or persistent pain at the graft site. Specific to P-15L Bone Graft could be reactions related to bone growth or integration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 80 years old.

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

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My affected spinal discs are between L2 and S1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my spine before.

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I currently have cancer.

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My back pain is not caused by a disc problem.

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I need surgery for multiple spinal discs causing pain.

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I need surgery to fuse more than one level of my spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fusion

Neurological deficit

No serious device-related adverse event

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: P-15L Bone GraftExperimental Treatment1 Intervention

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

Group II: Local autologous boneActive Control1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Degenerative Disc Disease (DDD) that promote bone growth and healing, such as bone grafts, work by providing a scaffold that supports new bone formation and facilitates the fusion of vertebrae. This stabilization of the spine helps to reduce pain and improve function. These treatments are essential for DDD patients as they address the core problem of disc degeneration and spinal instability, offering a potential path to long-term relief and improved quality of life.

Disc degeneration: current surgical options.