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

Participant Requirements:

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

Participant Requirements:

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.

Degenerative Disc Disease

Condition:

Degenerative disc disease

Participant Requirements:

  • Skeletally mature adults who are 22-80 years old
  • Back pain with radicular symptoms as evidenced by leg pain
  • Radiographically determined discogenic origin of the pain

Summary:

This study focuses on individuals who have been diagnosed with degenerative disc disease (wearing out of the discs in the spine) and who have been referred for surgical treatment to fuse (connect) the bones surrounding the damaged disc because they have not responded to non-surgical treatments such as pain medication and physical therapy. 

Condition: 

Degenerative disease of the lumbosacral spine

Participant Requirements:

  • Radiographic evidence of degenerative disease of the lumbosacral spine
  • History of low back pain
  • At least 18 years old and skeletally mature at the time of surgery

Summary:

This study focuses on individuals who have been diagnosed with degenerative disc disease at one or more levels of their spine and who have not responded to non-surgical treatments. The purpose of the study is to evaluate the investigational use of the Infuse Bone Graft in combination with the Capstone Spinal System (a spinal spacer device) and an implantable, metal rod and screw system plus autograft bone (the patient’s own bone) to determine whether it is safe and effective when used in a transforaminal lumbar interbody fusion (TLIF) surgery.

Osteoarthritis

Condition:

Osteoarthritis

Participant Requirements:

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

Participant Requirements:

  • 40-80 years old and in general good health, apart from knee osteoarthritis (OA)
  • Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time)
  • Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology criteria

Summary:

This study focuses on individuals with knee osteoarthritis who are 40-80 years old. Osteoarthritis (OA) is a type of arthritis that occurs when protective cartilage at the ends of bones wears down. The purpose of the study is to evaluate the safety and effectiveness of an experimental drug called SM04690, given as a single knee injection, to treat the most painful knee of osteoarthritis patients.

Shoulder Joint Replacement Surgery

Condition:

Primary shoulder joint replacement surgery

Participant Requirements:

  • At least 18 years old and skeletally mature
  • If a candidate for total shoulder arthroplasty, participants must meet specific subcriteria or if a hemiarthroplasty candidate, must meet specific subcriteria
  • Willing and able to complete scheduled follow-up visits, evaluations and questionnaires

Summary:

This study focuses on individuals who have severely painful and/or disabled joints resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis, or who have serious fractures of the humerus (the long bone in the upper half of the arm) and will undergo primary shoulder replacement surgery using the Titan-2.5 as standard of care for their condition.

Spinal Stenosis

Condition:

Degenerative lumbar spinal stenosis

Participant Requirements:

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.

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