You Deserve the Best in Advanced Orthopedic Care
Clinical Trials for Orthopedic Pain
NEW STUDY, CURRENTLY RECRUITING
Xalud XT-150 - Clinical Trial for Knee Osteoarthritis
This is a Phase 2 clinical trial study of investigational drug XT-150 in participants experiencing moderate to severe pain due to osteoarthritis of the knee. XT-150 is a plasmid DNA that will be injected into the intra-articular space of the affected knee and has been shown to reduce inflammation through cytokine IL-10. The possible benefits of this clinical study include increased mobility following a single dose, reduction in the requirement for pain medications/therapies, and reduction in pain symptoms. This study involves a total of 15 visits at our site over the course of 1 year, and includes a stipend for each visit.
See if you’re eligible: Xalud Knee OA Pre-Screening
CURRENTLY ON HOLD
TissueGene Clinical Trial - Cellular Treatment for Knee Osteoarthritis
This is a Phase 3 clinical trial study of investigational drug TG-C in participants living with chronic knee osteoarthritis. TG-C is to be administered by a single intra-articular injection to the damaged joint area. Patients will be followed for 24 months for safety and efficacy. Possible benefits include delayed progression of knee OA, longer knee joint preservation, and improved quality of life. The study will include follow-up visits over the course of 24 months, and includes a stipend for each visit.
See if you’re eligible: TissueGene Knee OA Pre-Screening
**Although the study is on hold, do not hesitate to fill out the screening survey! We will contact you with updates about when the study will start up.
NEW STUDY, CURRENTLY RECRUITING
SI-6603 (Condoliase) Clinical Trial for Lumbar Disc Herniation
This is a Phase 3 clinical trial study of investigational drug SI-6003 (Condoliase) in participants with lumbar disc herniation. SI-6003 is a single intradiscal treatment injection to the herniated disc. Potential benefits include reduced leg pain, reduced low back pain, and/or improved numbness of associated extremities. This study will include follow-up visits over the course of 13 months, and includes a stipend for each visit.
See if you’re eligible: SKK Disc Herniation Pre-Screening
POST ENROLLMENT DATA COLLECTION
IDCT Cellular Treatment for Low Back Pain (Discgenics Allograft Progenitor Disc Cell):
FDA Clinical trial – This is a Phase I, first‑in‑human, randomized, double‑blind, vehicle and placebo-controlled, parallel‑group, multi-center study in subjects with single‑level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).
POST ENROLLMENT DATA COLLECTION
VAST Study (Allograft for Low Back Pain)
FDA trial – This is a prospective, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Stem Cells combined with Micronized Allograft Nucleus Pulposos in subjects with chronic discogenic low back pain (>6 months) associated with moderate Degenerative Disc Disease (DDD).
POST ENROLLMENT DATA COLLECTION
MESOBLAST INTRADISCAL (Stem Cell Study for Low Back Pain)
Phase III FDA trial – This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast‘s rexlemestrocel-L alone or combined with hyaluronic acid (HA) in subjects with chronic discogenic lumbar back pain (>6 months) associated with moderate Degenerative Disc Disease (DDD).
Mesoblast has developed a proprietary mesenchymal lineage adult Stem Cell (MLC). These Stem Cells are found in multiple tissues where they play a vital role in maintaining tissue health.
Stem Cells have been found to secrete biomolecules involved in enhanced migration and proliferation of intervertebral disc progenitor cells, and in enhanced proteoglycan and collagen synthesis in the disc nucleus and annulus. These biomolecules include Angiopoietin-1 and transforming growth factor beta.
PREVIOUS CLINICAL TRIALS
JOINTSTEM STUDY (Stem Cell Study for Knee Pain)
Phase II, double-blind, randomized, controlled study with two arms to evaluate JointStem (an autologous stem cell line derived from your own fat tissue) as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 45 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After the last subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the database will be locked and the blinding will be open for the statistical analysis. Subjects will then be scheduled for 9-month and 12-month follow-up visits (Visits 7 and 8).
Adipose (fat tissue) is harvested from the abdomen by liposuction. The adipose tissue is then processed to isolate stem cells. The stem cells are then expanded in a sterile lab setting over a number of days to create the Investigational Drug. The subjects are then randomized for knee injection between the Investigational Drug (Autologous Expanded Stem Cell Line) or Hyaluronic Acid.
THE STEPS – TOTALIS™ TRIAL (Lumbar Stenosis Study)
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Surgery in patients with lumbar spinal stenosis
CYTONICS CLINICAL TRIAL (Platelet Poor Plasma for Knee Pain)
APIC-CF Therapy for Mild to Moderate Osteoarthritis of the Knee. The mechanism of Osteoarthritis (OA) is complex, however, the investigators know that cartilage breakdown follows changes in certain cells in the cartilage called chondrocytes, leading to proteases that break down cartilage. There is a protein in the human blood called alpha-2-macroglobulin that can trap these proteases and prevent the breakdown of cartilage. Cytonics developed a device that uses the patient’s own blood to remove all cells and concentrate alpha-2-macroglobulin to be injected in the painful knee due to osteoarthritis.
RELIEF CLINICAL TRIAL (Spinal Cord Stimulator Study for Chronic Pain)
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use and To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.
COOLIEF TRIAL (Knee Pain Study)
Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain. This study is designed to:
- Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
- Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection
ACCURATE CLINICAL TRIAL
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
The purpose of this study is to investigate whether the StimRouter (SR) electrical stimulation therapy leads to clinically important pain relief in patients with chronic intractable pain of peripheral nerve origin after three months of treatment. At the same time, this study will gather information on side effects associated with the StimRouter electrical stimulation therapy.
SMART CLINICAL TRIAL
To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.
MESOBLAST INTRADISCAL CLINICAL TRIAL FOR DEGENERATIVE DISC DISEASE
Phase II FDA trial – The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1.
All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc’s nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only.
BIOSTAT INTRADISCAL CLINICAL TRIAL FOR DEGENERATIVE DISC DISEASE
Phase III FDA trial – The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.