Virtuos for Degenerative Disc Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Orthofix Inc.
Disqualifiers: Under 18, Prior lumbar fusion, Malignancy, Pregnancy, Infection, others
No Placebo Group
Trial Summary
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.
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.
12345What 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.
678910Eligibility 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
+6 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 younger than 18 years old.
+3 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Michigan Brain and SpineRoyal Oak, MI
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Who Is Running the Clinical Trial?
Orthofix Inc.Lead Sponsor
References
Regeneration of intervertebral disc tissue by resorbable cell-free polyglycolic acid-based implants in a rabbit model of disc degeneration. [2011]: Different biologic strategies exist to treat degenerative disc disease. Tissue engineering approaches favor autologous chondrocyte transplantation. In our one-step-approach, a resorbable cell-free polyglycolic acid (PGA)-based implant is immersed in serum from whole blood and implanted into the disc defect directly after discectomy.
National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. [2022]Surgical treatment for lumbar degenerative disc disease (DDD) remains controversial. Options include anterior lumbar interbody fusion, posterior approach fusion procedures such as posterior lumbar interbody fusion (PLIF) and posterolateral lumbar fusion (PLF), anterior and posterior lumbar fusion (APLF), and total disc replacement (TDR). However, the trends during the last decade are uncertain.
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]Posterolateral spinal fusion with autologous bone graft is considered the "gold standard" for lumbar degenerative disc disease (DDD) when surgical treatment is indicated. The potential role of mesenchymal stromal cells (MSCs) to replace the bone graft in this setting has not been fully addressed.
Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. [2022]Degenerative disc disease is a major health concern in spine surgery. The aim of this systematic review was to summarize the current knowledge about injectable regenerative therapies (mesenchymal stem cells [MSC] or platelet rich plasma [PRP]) in degenerative disc disease.
Anterior lumbar interbody surgery for spondylosis results from a classically-trained neurosurgeon. [2016]Anterior lumbar surgery for degenerative disc disease (DDD) is a relatively novel technique that can prevent damage to posterior osseous, muscular and ligamentous spinal elements. This study reports the outcomes and complications in 286 patients who underwent fusion - with artificial disc implants or combined fusion and artificial disc implants - by a single-operator neurosurgeon, with up to 24 months of follow-up. The visual analogue scale (VAS), Oswestry Disability Index (ODI), Short Form 36 (SF36) and prospective log of adverse events were used to assess the clinical outcome. Radiographic assessments of implant position and bony fusion were analysed. Intraoperative and postoperative complications were also recorded. Irrespective of pre-surgical symptoms (back pain alone or back and leg pain combined), workers' compensation status and type of surgical implant, clinically significant improvements in VAS, ODI and SF36 were primarily observed at 3 and/or 6 month follow-up, and improvements were maintained at 24 months after surgery. A 94% fusion rate was obtained; the overall complication was 9.8% which included 3.5% with vascular complications. The anterior lumbar approach can be used for treating DDD for both back pain and back and leg pain with low complication rates. With appropriate training, single-operator neurosurgeons can safely perform these surgeries.
Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): an alternative to autogenous bone graft. [2022]Joint arthrodesis employing autogenous bone graft (autograft) remains a mainstay in the treatment of many foot and ankle problems. However, graft harvest can lead to perioperative morbidity and increased cost. We tested the hypothesis that purified recombinant human platelet-derived growth factor-BB (rhPDGF-BB) homodimer combined with an osteoconductive matrix (beta-tricalcium phosphate [β-TCP]) would be a safe and effective alternative to autograft.
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]Joint arthrodesis often employs autograft to promote union; graft harvesting can lead to perioperative morbidity. A Canadian randomized controlled trial (RCT) demonstrated that recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) combined with beta-tricalcium phosphate (β-TCP)-collagen was a safe, effective alternative to autograft. This multicenter North American RCT compared the safety and efficacy of rhPDGF-BB/β-TCP-collagen with autograft for ankle and hindfoot fusion. Subclassification using propensity scores (PS) incorporated patients from previous trials for enhanced statistical power for noninferiority testing and broader review of treatments.
Histological assessment of new bone formation with biomimetic scaffold in posterolateral lumbar spine fusion. [2021]Spinal fusion procedures often require the use of bone grafts (autograft or allograft) to help bone healing and to increase stability. However, the application of autografts is frequently limited by donor site morbidity. In recent years, different synthetic bone substitutes have been introduced in the clinical practice to overcome these limitations. The purpose of this paper is to report a case where a biomimetic, synthetic and osteoconductive bone graft substitute was successfully implanted in a patient during lumbar spine arthrodesis. The case of a 58-year-old female subjected to lumbar spine arthrodesis with bone augmentation is described. The bone graft substitute RegenOss® (Finceramica, Faenza, Italy) was implanted during spinal arthrodesis. The successful bone integration was evaluated by X-rays. After 11 months, the patient underwent a second surgery due to spine imbalance; the debris of the bone graft was therefore collected and analyzed by macroscopic evaluation and by histology. The bone substitute was successfully implanted during a spinal arthrodesis procedure. Histologic evaluation of the removed bone graft debris showed the complete resorption of the implant and the formation of new bone, which was well integrated with the host bone. This bone substitute may represent a safe and effective alternative to autologous bone grafts, avoiding adverse events related to donor-site morbidity.
The effect of matrix bound parathyroid hormone on bone regeneration. [2018]Autogenous bone is the most successful bone-grafting material; however, multiple disadvantages continue to drive developments of improved methods for bone regeneration.
The role of Osteocel Plus as a fusion substrate in minimally invasive instrumented transforaminal lumbar interbody fusion. [2022]Instrumented lumbar fusion has become an accepted and effective surgical technique used to address a wide variety of conditions of the lumbar spine. Iliac crest autograft remains the gold standard with regards to bony fusion substrate. Unfortunately there are significant potential disadvantages associated with autograft harvest, including pain, infection, iatrogenic fracture and bleeding. Osteocel Plus (OC+) is an allograft cellular bone matrix containing mesenchymal stem cells (MSCs) and osteoprogenitor cells combined with DBM and cancellous bone. OC+ is designed to mimic the osteobiologic profile of human autograft bone, thereby eliminating the risks of autograft harvest.
A New Retinal Detachment Treatment Model for Evaluation of Vitreous Tamponades. [2021]Purpose: To develop a treatment model of rhegmatogenous retinal detachment (RRD) in which the effects of various vitreous tamponades can be explored. Methods: In a primary session, detachment was produced in the right eye of 24 rabbits using vitrectomy, posterior vitreous detachment, retinal break induction, and subretinal injection of viscoelastic solution. The following day, detachments were treated in 16 eyes using SF6 (n = 8) or Healaflow® (HF, a cross-linked hyaluronic acid hydrogel, n = 8) tamponade. Animals were followed for 1 month and thereafter examined macroscopically and morphologically in hematoxylin and eosin-stained sections. Results: Retinal detachment (RD) was successfully treated using repeated surgery. Two HF eyes developed progressive vitritis and were excluded from further evaluation. Enlargement of the initial retinal rupture with concomitant RD was seen in 4/8 SF6 eyes, while all 6 HF eyes displayed an attached retina. Attached areas showed a normal retinal morphology except for in 1 HF eye with extensive degeneration. Conclusions: The RRD repeat vitrectomy model offers a possibility to explore the efficacy and complications of novel potential vitreous tamponades. Gel-based Healaflow® displays excellent anatomic reattachment, however, vitritis and retinal degeneration in some cases warrants further investigation.
ADCON-L hydrogel as a vitreous substitute: preliminary results. [2006]The ideal vitreous substitute has still to be found. This report concerns the preliminary results of a translucent hydrogel, ADCON-L, used successfully in neurosurgery. We have used this hydrogel as a vitreous substitute in the right eye of New-Zealand albino rabbits following vitrectomy. The follow-up period was four weeks and the evaluation was followed by biomicroscopy, indirect ophthalmoscopy, and electroretinography. The results obtained suggest a potential retinotoxicity of this hydrogel as shown by the statistically significant reduction of the mean B-wave amplitude at day 14 (p
Anterior segment complications related to vitreous substitutes. [2005]Vitrectomy is the most common surgical technique performed in eyes with vitreoretinal disease. The development and widespread use of vitreous substitutes has revolutionized vitreoretinal surgery and improved anatomic and visual results. The three most common types of vitreous substitutes available in North America include silicone oil, intraocular gas, and perfluorocarbon liquid. Each of these agents has unique properties, allowing completely different roles of the agents in vitreoretinal surgery. The physical properties, clinical indications, and potential complications of these agents are described.
[Effectiveness of multistage surgical treatment of advanced proliferative diabetic retinopathy complicated with primary cataract]. [2020]Vitreoretinal surgery (VRS) is the «gold standard» for surgical treatment of patients with proliferative diabetic retinopathy (PDR). However, the timing for the removal of primary cataract in this category of patients remains uncertain.
[Suprachoroidal (subscleral) fillings of human fat for the operation of retinal ablations (author's transl)]. [2009]A report is given of experimental and clinical experiences on application of suprachoroidal (subscleral) fillings of human fat (0,5-0,8 cm3) for the operation for retinal detachment. The subcutaneous homoioplastic fat is homogenized and injected under the sclera close behind ligamentum pectinatum. After injection there is a hump similar to choroidal amotio. The filling is tolerated well. It serves to reduce the space of vitreous in relation with Custodis operation and cerclage of the bulbus. It is resorbed slowly and incompletely, or organised. Complications are to be feared if the ciliary body is perforated by injection and fat comes into the vitreous.