Orthopaedic Clinical Trials

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.

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.

Condition:

Degenerative disc disease

Participant Requirements:

• 25-75 years old (Females of childbearing potential must not be pregnant and must agree to use acceptable contraception for at least 12 months after surgery and investigational product placement.)
  
• Patients with degenerative disc disease with up to grade 1 spondylolisthesis and leg pain requiring up to 3 levels of laminectomy/decompression and single-level fusion
  

Summary:

The purpose of this study is to examine the safety and effectiveness of an investigational drug called KUR-113 Bone Graft (compared to a local autograft) as a possible treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion.

Condition:

Fracture

Participant Requirements:

• At least 18 years old
• Diagnosis of (one of either fracture type and isolated injury):
  • Hip fracture
  • Tibial shaft fracture (with and without associated fibular fracture)
  • Ankle/pilon fracture
  • Proximal humerus fracture
  • Distal radius fracture
    

Summary:

This study focuses on individuals who have had one of the following fractures: hip, ankle, shinbone (leg), upper arm, or forearm. The purpose of the study is to collect information that will help doctors provide care that meets patients’ needs by providing better information about the biological, psychological, and social factors that affect their health. To this end, participants will be asked to complete survey questionnaires.

Condition:

Distal femur fracture

Participant Requirements:

• 65 years and older
• Isolated fracture of the distal femur
• Fracture is acute (within 1 week from time of injury)

Summary:

This study focuses on individuals who have a distal femur fracture. A distal femur fracture is a condition in which the bone breaks in several pieces above the knee joint, requiring surgery. The purpose of the study is to determine which of two types of treatment for distal femur fracture will result in less pain and best recovery (i.e., walk faster, return to daily activities).

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:

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.

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.