Clinical Trials

The “MAKO Study” is a case-controlled clinical evaluation of outpatient robotic vs. traditional partial knee arthroplasty. The purpose of this study aims to compare intraoperative and post-operative data for patients undergoing unilateral partial knee replacement both with and without robotic guidance. Robotic guidance is performed by the MAKO robot developed by Stryker. This study involves investigating the discharge and readmission rates and patient pain scores in the post-anesthesia care unit (PACU), of MAKO Robotic-Arm Assisted UKA performed in an outpatient ambulatory surgery center (ASC) compared to conventional UKA in the same setting. Patients with eligible surgeries will be called and asked if they would like to answer our brief surveys on the days of their surgeries.

The “NuDyn study” is a double-blinded randomized controlled trial evaluating amniotic membrane injections for patients with knee osteoarthritis. The final treatment option for osteoarthritis of the knee is a partial or total knee replacement. However, there are many non-surgical treatments that may control pain or delay progression of osteoarthritis. Newer treatments such as injectable amniotic membrane tissue products made from placental tissue provide an alternative option to corticosteroid injections. The NuDyn injection is an amniotic fluid injection derived from processed donor placenta. NuDyn is available for sale in the United States and has been registered on the FDA’s Human Cell and Tissue Establishment Registration site. The injection is thought to modulate inflammation in the knee joint and promote healing. While the injections have been used for many years with good anecdotal results, high quality research is lacking. Our study is a double-blinded dosage effect study with three legs: 1 cc, 2 cc, and placebo (sterile saline). Patients who enroll in the study are randomized to one of the study groups and have a ⅔ chance of receiving the NuDyn injection. Follow-up visits occur 1-month, 3-months, 6-months, and 12-months after the date of injection. Data is collected through patient questionnaires completed prior to follow-up visits.

The MVP study is a Multi-center study evaluating the efficacy of intraoperative platelet rich plasma (PRP) vs bone marrow venting (BMVP) in healing rates of meniscus repairs. Surgeons, in an attempt to create a favorable healing response observed in meniscal repairs, perform bone marrow venting procedures concomitantly for augmentation of isolated meniscal repairs. Bone marrow venting procedures are thought to help augment meniscal repair. This procedure involves creating very small poke-holes in a non weight-bearing area of the bone that does not involve any critical structures. These holes act as channels, which allow for the flow of the patients’ own growth factors from the bone marrow. Like bone marrow venting procedures, injecting PRP is thought to increase the concentration of healing factors at the operative site and augment healing. Platelet rich plasma is plasma processed from the patient’s own blood and is rich with growth and healing factors. Both are considered reasonable methods for meniscal repair augmentation.

The study is a single-blind, randomized, parallel group, superiority trial. Patients are followed in the study for one year beyond the date of their surgery. Patients are assessed at 2 weeks, 6 weeks, 3 months, and 1 year. At the 3 month and 1 year follow up visit, patients are asked to fill out subjective questionnaires and their responses are recorded. Patients are also compensated upon completion of their participation in the study.