Virtuos for Degenerative Disc Disease

No longer recruiting at 2 trial locations

Overseen By Christopher Gunter, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orthofix Inc.

Disqualifiers: Under 18, Prior lumbar fusion, Malignancy, Pregnancy, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for degenerative disc disease (DDD), which causes back pain due to worn-out discs in the spine. The study tests whether the Virtuos bone graft or the traditional Autograft (using a patient’s own bone) is more effective for spine fusion surgery. Participants should have experienced DDD-related back pain that hasn't improved with other treatments for at least six months and may have other spine issues, such as a slipped vertebra (spondylolisthesis). As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment options for DDD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows limited specific safety information for the Virtuos bone graft treatment. However, its inclusion in studies indicates promise from earlier research. Generally, treatments in these studies are often well-tolerated, though individual reactions can vary.

Autograft treatment, on the other hand, is commonly used and generally considered safe. It uses a person's own bone, which typically reduces the risk of rejection or infection.

Both treatments are being compared to ensure safety and effectiveness for people with degenerative disc disease. Researchers closely monitor participants in clinical trials to manage any side effects. Those considering joining a trial should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtuos for degenerative disc disease because it offers something different from the usual surgical options like spinal fusion or standard autografts. Unlike these treatments, which often involve using bone from the patient's own body or from donors, Virtuos uses a synthetic bone graft substitute. This can potentially reduce the need for additional surgeries to harvest bone and may decrease the risk of complications. By incorporating local bone, Virtuos aims to enhance the body's natural healing process, potentially leading to better outcomes and faster recovery.

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

Research has shown that Virtuos, a bone graft made from donor cells, holds promise for aiding spinal fusion in the lower back. Studies have found it effective in achieving this fusion, crucial for treating worn-out spinal discs. Although specific data for this condition remains limited, early results suggest it could improve fusion rates. In this trial, some participants will receive Virtuos, while others will receive autografts, which use the patient's own bone and have long been successful in similar surgeries. Both treatments in this trial aim to stabilize the spine and reduce pain by promoting bone growth and fusion. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Virtuos Experimental Treatment 1 Intervention

Virtuos +/- Local Bone

Group II: Autograft Active Control 1 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

Who Is Running the Clinical Trial?

Orthofix Inc.

Lead Sponsor

Trials

18

Recruited

6,600+

Published Research Related to This Trial

In a study of 23 patients undergoing minimally invasive transforaminal lumbar interbody fusion (MITLIF) using Osteocel Plus (OC+), 91.3% achieved solid bony fusion within 12 months, indicating high efficacy of this allograft cellular bone matrix.

OC+ not only mimics the properties of autograft bone but also eliminates the risks associated with autograft harvest, making it a safer alternative for patients with risk factors for nonunion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Osteocel Plus as a fusion substrate in minimally invasive instrumented transforaminal lumbar interbody fusion. Ammerman, JM., Libricz, J., Ammerman, MD.[2022]

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]

The use of suprachoroidal injections of human fat (0.5-0.8 cm³) for retinal detachment surgery has shown good tolerance and serves to reduce vitreous space, aiding in procedures like Custodis operation and cerclage.

While the fat filling is slowly resorbed and can be organized, there is a risk of complications if the injection accidentally perforates the ciliary body, potentially leading to fat entering the vitreous.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Suprachoroidal (subscleral) fillings of human fat for the operation of retinal ablations (author's transl)]. Sachsenweger, R., Hartwig, H.[2009]

Vitreous substitutes like silicone oil, intraocular gas, and perfluorocarbon liquid have significantly improved the outcomes of vitrectomy surgery for vitreoretinal diseases, enhancing both anatomical and visual results.

Each type of vitreous substitute has distinct physical properties and clinical uses, which can influence the choice of agent based on the specific needs of the surgery and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior segment complications related to vitreous substitutes. Kim, RW., Baumal, C.[2005]

Injectable regenerative therapies, such as mesenchymal stem cells (MSC) and platelet-rich plasma (PRP), have shown significant clinical improvement in patients with degenerative disc disease, based on a systematic review of 17 studies involving 380 patients.

No major complications or adverse effects were reported from these treatments, indicating a good safety profile, although none of the studies demonstrated improvements in disc height on imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. DI Martino, A., Barile, F., Fiore, M., et al.[2022]

The study successfully developed a model for treating rhegmatogenous retinal detachment (RRD) in 24 rabbits, allowing for the evaluation of different vitreous tamponades.

Healaflow® (HF), a cross-linked hyaluronic acid hydrogel, showed better retinal reattachment compared to SF6 gas, with all HF-treated eyes remaining attached, although some cases experienced complications like vitritis and retinal degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Retinal Detachment Treatment Model for Evaluation of Vitreous Tamponades. Barth, H., Crafoord, S., Ghosh, F.[2021]

The study demonstrated that a polyethylene glycol (PEG) matrix modified with RGD peptides and containing parathyroid hormone (PTH(1-34)) significantly enhanced bone regeneration compared to PEG alone or empty defects, achieving similar results to autogenous bone after 12 weeks.

Histomorphometric analysis showed that the area fraction of newly formed bone was comparable between the RGD-PEG-PTH group and the autogenous bone group, indicating that this new matrix system is a promising alternative for bone regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of matrix bound parathyroid hormone on bone regeneration. Jung, RE., Cochran, DL., Domken, O., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 286 patients undergoing anterior lumbar surgery for degenerative disc disease, significant improvements in pain and disability scores were observed at 3, 6, and 24 months post-surgery, indicating the efficacy of this surgical approach.

The surgery achieved a high fusion rate of 94% with a relatively low overall complication rate of 9.8%, including 3.5% vascular complications, suggesting that this technique is safe when performed by trained neurosurgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior lumbar interbody surgery for spondylosis results from a classically-trained neurosurgeon. Chatha, G., Foo, SW., Lind, CR., et al.[2016]

The translucent hydrogel ADCON-L, used as a vitreous substitute in New-Zealand albino rabbits after vitrectomy, showed potential retinotoxicity, indicated by a significant reduction in B-wave amplitude in electroretinography at 14 and 28 days post-surgery.

There was also a notable postoperative inflammatory reaction, suggesting that while ADCON-L may be a candidate for vitreous substitution, its safety and effects on retinal function need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADCON-L hydrogel as a vitreous substitute: preliminary results. De Jong, C., Bali, E., Libert, J., et al.[2006]

In a study of 94 patients with advanced proliferative diabetic retinopathy (PDR) and primary cataract, a two-step surgical approach (vitreoretinal surgery followed by cataract surgery) led to visual improvement in 88.8% of cases with standard support and 83.4% with anti-VEGF treatment.

The staged surgical treatment was found to be safer, as it reduced intraoperative and postoperative complications compared to simultaneous surgery, especially when anti-VEGF injections were administered before the first surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of multistage surgical treatment of advanced proliferative diabetic retinopathy complicated with primary cataract]. Konovalova, KI., Shishkin, MM., Fayzrakhmanov, RR.[2020]

In a study involving 434 patients, the combination of purified recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and beta-tricalcium phosphate (β-TCP) showed comparable fusion rates to autogenous bone graft (autograft) for hindfoot or ankle arthrodesis, with 61.2% of patients in the rhPDGF-BB/β-TCP group achieving fusion at six months.

Patients treated with rhPDGF-BB/β-TCP reported less pain and had a better safety profile compared to those receiving autograft, indicating it may be a safer and effective alternative for this surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): an alternative to autogenous bone graft. DiGiovanni, CW., Lin, SS., Baumhauer, JF., et al.[2022]

In a multicenter randomized controlled trial involving 132 patients treated with rhPDGF-BB/β-TCP-collagen and 35 patients receiving autograft, the rhPDGF-BB/β-TCP-collagen treatment demonstrated noninferiority in achieving joint fusion and clinical healing outcomes compared to autograft.

The use of rhPDGF-BB/β-TCP-collagen resulted in less pain and lower morbidity than traditional autograft methods, making it a safer and effective alternative for ankle and hindfoot fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Daniels, TR., Anderson, J., Swords, MP., et al.[2022]

A case study of a 58-year-old woman demonstrated that the synthetic bone graft substitute RegenOss® was successfully implanted during lumbar spine arthrodesis, showing promising results in bone integration as evaluated by X-rays.

Histological analysis of the graft debris after 11 months revealed complete resorption of the synthetic material and the formation of new bone, indicating that this substitute could be a safe and effective alternative to traditional autografts, minimizing donor site complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histological assessment of new bone formation with biomimetic scaffold in posterolateral lumbar spine fusion. Gioia, G., Agnoletto, M., Di Giancamillo, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06686017

NCT06686017 | Virtuos Bone Graft in Lumbar Fusion The fusion rates observed at 12-months will be compared to an historical group of patients that underwent a one or two level lumbar fusion procedure with an ...

2. tipranks.com tipranks.com/news/company-announcements/orthofixs-virtuos-bone-graft-study-a-promising-update-for-lumbar-fusion

Orthofix's Virtuos Bone Graft Study: A Promising Update for ... ' The study aims to evaluate the effectiveness of a cellular-based allograft bone graft, Virtuos, in lumbar spinal fusion for patients with ...

3. withpower.com withpower.com/trial/phase-intervertebral-disc-degeneration-2023-39932

Virtuos for Degenerative Disc Disease The available research does not provide specific data on the effectiveness of Virtuos for Degenerative Disc Disease. However, it mentions that ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT05614284

Comparative Analysis of Virtuous and Autograft in Lumbar ... The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05614284

Comparative Analysis of Virtuous and Autograft in Lumbar ... The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT06686017

Virtuos Bone Graft in Lumbar Fusion - Clinical Trial Finder Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness ( ...