75 Participants Needed

Virtuos for Degenerative Disc Disease

CG
Overseen ByChristopher Gunter, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Orthofix Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the idea that Virtuos for Degenerative Disc Disease is an effective treatment?

The available research does not provide specific data on the effectiveness of Virtuos for Degenerative Disc Disease. However, it mentions that posterolateral spinal fusion with autologous bone graft is considered the 'gold standard' for this condition. This suggests that using one's own bone for grafting is a well-regarded treatment option. Other studies discuss different surgical methods and regenerative therapies, but none specifically evaluate Virtuos. Therefore, there is no direct evidence from the provided information to support the effectiveness of Virtuos for this condition.12345

What safety data exists for Virtuos treatment for Degenerative Disc Disease?

The research does not provide specific safety data for Virtuos or its other names like Autograft or Autologous bone graft. However, it discusses alternatives to autografts, highlighting the safety and effectiveness of synthetic bone substitutes and recombinant growth factors as alternatives, which avoid donor-site morbidity associated with autografts. These alternatives have been shown to be safe and effective in various studies, suggesting that similar treatments may also be safe.678910

Is Virtuos a promising treatment for Degenerative Disc Disease?

The information provided does not include any relevant details about Virtuos or its effectiveness for Degenerative Disc Disease. Therefore, we cannot determine if it is a promising treatment based on the given data.1112131415

What is the purpose of this trial?

Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuous or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.

Eligibility Criteria

This trial is for adults over 18 with Degenerative Disc Disease (DDD) needing lumbar spine fusion surgery at 1-2 levels. They must have tried conservative care for 6+ months without relief, and can't be pregnant or planning pregnancy within two years post-surgery. Prior lumbar fusion or treatment for malignancy in the last five years disqualifies them.

Inclusion Criteria

I need a specific spine surgery involving 1-2 backbones.
I can attend all follow-up visits and follow the study plan.
Agree not to use electromagnetic adjuncts for bone fusion
See 5 more

Exclusion Criteria

Pregnant, nursing, or planning pregnancy within 24 months following surgery
I am currently receiving treatment for cancer or have recently.
I am currently fighting an infection or being treated for one.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo transforaminal lumbar interbody fusion with either Virtuous or Autograft bone graft

1 week

Follow-up

Participants are monitored for fusion status and clinical outcomes

12 months
Regular follow-up visits as per study protocol

Extended Follow-up

Participants are monitored for safety profile and long-term outcomes

24 months

Treatment Details

Interventions

  • Autograft
  • Virtuos
Trial Overview The study compares the effectiveness of a bone graft material called Virtuos against traditional Autograft Bone Graft in lumbar spine fusion surgeries after 12 and 24 months. The surgical approach includes TLIF with posterior fixation, following FDA guidelines.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: VirtuousExperimental Treatment1 Intervention
Virtuous +/- Local Bone
Group II: AutograftActive Control1 Intervention
Autograft +/- Allograft Chips

Autograft is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Autograft for:
  • Lumbar fusion
  • Spinal fusion
  • Bone defects
  • Fractures
  • Delayed union
  • Nonunion
🇪🇺
Approved in European Union as Autograft for:
  • Orthopedic trauma
  • Bone reconstruction
  • Spinal fusion
  • Lumbar fusion

Find a Clinic Near You

Who Is Running the Clinical Trial?

Orthofix Inc.

Lead Sponsor

Trials
18
Recruited
6,600+

Findings from Research

A cell-free implant made of polyglycolic acid and hyaluronic acid, when immersed in serum and implanted after discectomy in rabbits, significantly improved disc regeneration and water content over 6 months, as shown by a 45% increase in T2-weighted signal intensity.
Histological analysis confirmed that the implant successfully attracted local cells to the defect, leading to tissue regeneration and preservation of disc height, while control animals showed a decrease in disc height and signal intensity.
Regeneration of intervertebral disc tissue by resorbable cell-free polyglycolic acid-based implants in a rabbit model of disc degeneration.Abbushi, A., Endres, M., Cabraja, M., et al.[2011]
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.
National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009.Yoshihara, H., Yoneoka, D.[2022]
In a Phase I/II clinical trial involving 11 patients with degenerative disc disease, the implantation of autologous mesenchymal stromal cells (MSCs) embedded in tricalcium phosphate was found to be safe, with no adverse effects related to the cell implantation reported.
Efficacy results showed significant improvements in pain and disability scores post-surgery, with 80% of patients achieving successful lumbar fusion by the end of the follow-up period, suggesting that MSCs could be a viable alternative to traditional bone grafts in spinal fusion procedures.
Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up.Blanco, JF., Villarón, EM., Pescador, D., et al.[2020]

References

Regeneration of intervertebral disc tissue by resorbable cell-free polyglycolic acid-based implants in a rabbit model of disc degeneration. [2011]
National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. [2022]
Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. [2020]
Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. [2022]
Anterior lumbar interbody surgery for spondylosis results from a classically-trained neurosurgeon. [2016]
Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): an alternative to autogenous bone graft. [2022]
Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an Alternative to Autograft. [2022]
Histological assessment of new bone formation with biomimetic scaffold in posterolateral lumbar spine fusion. [2021]
The effect of matrix bound parathyroid hormone on bone regeneration. [2018]
The role of Osteocel Plus as a fusion substrate in minimally invasive instrumented transforaminal lumbar interbody fusion. [2022]
A New Retinal Detachment Treatment Model for Evaluation of Vitreous Tamponades. [2021]
ADCON-L hydrogel as a vitreous substitute: preliminary results. [2006]
13.United Statespubmed.ncbi.nlm.nih.gov
Anterior segment complications related to vitreous substitutes. [2005]
14.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Effectiveness of multistage surgical treatment of advanced proliferative diabetic retinopathy complicated with primary cataract]. [2020]
[Suprachoroidal (subscleral) fillings of human fat for the operation of retinal ablations (author's transl)]. [2009]
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