Orthopaedic Clinic Trials

We're dedicated to bringing innovative technology to our patients through clinical trials and research. These clinical trials may lead the way to new experimental approaches and instrumentation that affect the way orthopaedic procedures are done and may result in more effective outcomes.

Questions? See the Clinical Trial FAQs or search all clinical trials.

Ankle Fractures

Condition:

Ankle fractures

Participants Must:

Be diagnosed with an unstable, closed, isolated fracture of the ankle; have undergone operative stabilization with plate(s) and/or screws; be at least 21 years old; be able to begin treatments with the bone growth stimulation unit within 11 days of surgical stabilization.

Summary:

This study focuses on individuals who have had a fresh, closed, unstable ankle fracture that required surgery. The purpose of the study is to evaluate the safety and effectiveness of the CMF OL1000 Bone Growth Stimulator device for unstable ankle fractures that require surgical intervention for stabilization. 

Cartilage Defects of the Knee

Condition:

Cartilage defects of the knee

Participants Must:

Be between 18-60 years old; have a body mass index <35 kg/m²; have symptomatic lesion classified as International Cartilage Repair Society grade 3 or 4.

Summary:

This study focuses on patients who have damage to their knee cartilage. The purpose of the study is to evaluate the safety and effectiveness of Hyalofast, a sterile pad which is soaked in the patient’s own stem cells taken from their hip, called autologous bone marrow aspirate concentrate (BMAC) (a type of biopsy procedure) and inserted into damaged knee cartilage.

Magnetic Resonance Contrast Imaging

Condition:

Nephrogenic systemic fibrosis

Participants Must:

Be at least 18 years old; be scheduled for an orthopaedic surgical procedure; be scheduled to have sufficient bone removed during the orthopaedic surgical procedure and sufficient nonscarred skin tissue from the edge of the surgical incision or amputated part to permit sample collection.

Summary:

The purpose of this study is to further evaluate the safety of six commercially used gadolinium-containing contrast agents. In order to obtain a better view of internal organs, contrast agents containing gadolinium are often administered during magnetic resonance imaging. The screening procedure to be used will not evaluate any treatment but is a required first step to determine eligibility to enter the study.

Osteoarthritis

Condition:

Osteoarthritis

Participants Must:

Be between 50-80 years old; have osteoarthritis grade 2-3 according to the Kellgren and Lawrence grading scale; have knee pain level of at least 5 on the  0-10-point WOMAC A subscale.

Summary:

This study focuses on individuals between 50 and 80 years old who suffer from moderate osteoarthritis (OA) in the knee, have at least moderate knee pain level, and have only slight osteoarthritis in the less severe arthritic knee. The purpose of the study is to determine whether an experimental treatment based on the combination of autologous platelet rich plasma (use of one's own blood) and Hyaluronic acid (HA- a major component of synovial fluid in the knee), when using the A-CP HA kit injected into the knee, might improve the patient's osteoarthritis-related symptoms and reduce pain better than HA alone or a placebo (inactive substance).

Condition:

Osteoarthritis

Participants Must:

Be at least 21 years old and not older than 60 years old, with body mass index ≤40; have a diagnosis of knee OA; have mild to moderate knee OA pain.

Summary:

This study focuses on active individuals who have osteoarthritis (OA) pain of the knee and who have failed to respond well to previous conservative non-medication therapy and therapy using simple analgesic medications (such as acetaminophen). Researchers will obtain information on the safety and performance of high molecular weight viscoelastic hyaluronan (HYMOVIS), when combined with a physical exercise program, for reducing pain associated with osteoarthritis of the knee. HYMOVIS is approved by the U.S. Food and Drug Administration for injection into the knee joint of patients with osteoarthritis of the knee.

Postoperative Wound Infections

Condition:

Postoperative wound infection after fracture surgery

Participants Must:

Have all "high energy" tibial plateau fractures, pilon fractures and calcaneus fractures treated operatively with plate and screw fixation; be 18-80 years old.

Summary:

The study is designed to test the investigational use of a higher mix of oxygen and determine the best treatment for severe lower leg injuries.

Spinal Stenosis

Condition:

Degenerative lumbar spinal stenosis

Participants Must:

Be 35-80 years old; demonstrate degenerative spondylolisthesis or retrolisthesis up to Grade I, at least moderate lumbar spinal stenosis, and thickening of the ligamentum flavum and/or scarring of the facet joint capsule; have had at least six months of failed conservative treatment prior to surgery.

Summary:

This study is designed to test the investigational use of the Total Posterior Spine (TOPS) System in patients who have been diagnosed with spine-related conditions. A spinal implant such as the TOPS System is intended as an alternative to fusion surgery because it stabilizes the vertebrae while still allowing movement of the joints between the vertebrae.

Condition:

Spinal stenosis

Participants Must:

Be at least 40 years old; have radiographic confirmation of at least moderate lumbar stenosis; have radiographic confirmation of no angular or translatory instability of the spine at index or adjacent levels.

Summary:

This study focuses on patients diagnosed with degenerative lumbar spinal stenosis whose symptoms have not responded to nonsurgical treatment. The purpose of the study is to evaluate the safety and effectiveness of the Coflex Interlaminar System, which is designed to stabilize the vertebrae while potentially still allowing some motion in the spine.

Tibial Fractures

Condition:

Tibial fractures

Participants Must:

Be 18-21 years old with evidence of proximal and distal tibial physeal closure, or be 22-75 years old; have Gustilo-Anderson Grade II, IIIA, or IIIB open tibial shaft fracture that can be fixed with an intramedullary nail (metal rod); have bone loss at the fracture site with a bone gap between 5 and 27.5 millimeters.

Summary:

The purpose of the study is to evaluate whether the treatment of open fractures of the central part of the tibia (long bone in the lower leg) with CERAMENT G is safer and more beneficial than the current standard surgical and medical care. CERAMENT G is intended to fill gaps in the bone to promote bone healing and help prevent infection.

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