Orthopaedic Clinical 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. 


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.


Orthopaedic Trauma Injuries

Condition:

Orthopaedic trauma injuries

Participants Must:

Be undergoing treatment on the Orthopaedic Trauma Service at Cedars-Sinai; be 18 or older.

Summary:

The purpose of this data registry is to compare treatment strategies that are commonly utilized to treat fractures and to accurately measure the results of treatment using validated statistical outcome measures.


Osteoarthritis

Condition:

Osteoarthritis

Participants Must:

Be experiencing moderate knee osteoarthritis; have radiographic findings consistent with osteoarthritis as documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3); be at least 18 years old.

Summary:

This study focuses on patients with moderate osteoarthritis. The purpose of the study is to evaluate the safety and effectiveness of the ReNu injection. ReNu is a human tissue allograft (tissue transplanted from one person to another) composed of amniotic fluid cells and amniotic membrane, both from the same donor.


Condition:

Osteoarthritis (OA)

Participants Must:

Be at least 40 years old; have symptoms associated with OA of the index knee for at least six months prior to screening; currently meet American College of Rheumatology criteria for OA; be ambulatory and in good general health

Summary:

This study focuses on patients diagnosed with osteoarthritis of the knee. The purpose of the study is to examine the use of an investigational drug called FX006 on patients with symptomatic osteoarthritis of the knee.


Condition:

Osteoarthritis

Participants Must:

Be adults who are entering orthopaedic practices to see their physician.

Summary:

The purpose of this study is to evaluate whether physician attire influences patients' opinions of their doctors. Previous studies have reported that physician attire may be an important factor in a patient's trust in their surgeon, confidence in their surgeon's skill and perception of their intelligence.


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.


Condition:

Extremity fractures / postoperative wound infections

Participants Must:

Have any fractures of any bone at or proximal to and including the tarsal/metatarsal joint or proximal to the carpal joints, excluding the spine, treated with any type of internal fixation; be undergoing fusion of any bone at or proximal to and including the subtalar joint or radial carpal joint (excluding the spine), that develops a postoperative wound infection.

Summary:

This study focuses on patients who have a long bone fracture and an infection in their wound. The purpose of the study is to determine the best treatment for such infections.


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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