C. Thomas Vangsness, Jr., M.D is involved in several FDA and IRB approved clinical research trials that you may be able to participate in.

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Anterior Cruciate Ligament Injuries (ACL)

Study # 1
This study is for patients who have a torn ACL and are planning on having surgery to reconstruct their ligament. It is designed to compare the efficacy of pre-shaped patellar tendon allografts that have undergone the BioCleanse process to the clinical outcome of other standard allograft tissue preparations.

“Evaluation of BioCleanse Patellar Tendon Allografts for the Reconstruction of Allografts for the Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized, Investigation.”

The ligament is reconstructed with tissue from either you, the patient (autograft), or from a cadaver (allograft). Allografts have been commonly used since the early 1980’s. The major concern in using allografts is contamination or transmission of disease from the donor. The most common sterilization method used is gamma irradiation. BioCleanse is another process that cleans and sterilizes this donated tissue.

To be eligible, you must be 18-55 years old, have an ACL tear that is less than 6 months old and plan on having surgery. Participants will be randomly divided into two groups. One group will receive the BioCleanse allograft and the other group will receive the allograft that is sterilized with gamma radiation (irradiated). Regardless of which group you are in, all other aspects of your surgical and pos-operative care will remain the same. Your will need to see the doctor prior to surgery, for surgery, and then 5 times after surgery (at 6 weeks, 3, 6, 12, and 24 months).

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Meniscus Damage

This is a Stem Cell study to evaluate whether a single injection of adult stem cells into the knee after meniscectomy will regrow the meniscus and potentially protect the knee joint in the future.

“Phase I/II Randomized, Controlled, Double-blind, Study of Chondrogen – Adult Universal Cell Delivered by Intra-articular Injection Following Meniscectomy in Patients 18-60 years.”

This study is for patients who have a torn medial knee meniscus and are planning on having surgery to remove or repair this meniscus cartilage. Stem cells are capable of regenerating new meniscus cartilage. Chondrogen is an injection containing stem cells from donated adult human bone marrow. We hope to learn whether the injection into the knee can help to regrow the meniscus cartilage which may help protect the joint in the future from arthritis.

The active ingredients in Chondrogen are adult Mesenchymal Stem Cells (MSCs). The cells in this product come from normal healthy adult volunteer donors and are NOT derived from a fetus, embryo, or animal. Studies have shown that these cells are universally compatible. This means that, similar to blood type O, these MSCs may safely be used without tissue type matching for specific patients.

Participants in the study will be divided into 3 groups. One group will receive an injection without stem cells and the other two groups will have stem cells in the injection at 2 different dosages, a regular and high dose. All subjects will be randomly assigned to a group. Neither you nor your surgeon will know which group you are in. Regardless of which group you are assigned to, all other aspects of your care will remain the same.

If you are eligible to participate, you will need to see the physician 1-2 times before your surgery, 1 week after the surgery for the injection, and again for 5 more visits over a 2 year period (at 3, 6, 12, 18, and 24 months). During these follow up visits you will see the physician for a physical exam, complete paperwork, have blood test, and additional free MRIs to measure changes in the meniscus.

To be eligible, you nee to be 18-60 years old, have a tear in your medial knee meniscus, and choose to have surgery. You may not have advanced arthritis in your knee. If you are interested in participating in the study, other criteria will be discussed with you.




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Basic Science - Synovial Fluid Investigation

This is a study to evaluate the relationship between chemicals in the knee joint fluid and the amount of arthritis in subjects. This information may help us to determine the process of arthritis and to develop more specific treatments for prevention.

“Analysis of Synovial Fluid and Synovium in Osteoarthritic Knees”

Synovial fluid is the fluid in your joints. During routine knee surgery a small amount of fluid is routinely removed from your knee and discarded. If you agree to participate in the study, the normally discarded fluid will be labeled, frozen, and sent to a laboratory to be analyzed.

You are eligible to participate if you are planning on having knee surgery and are between 18-70 years old.