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  • MACI MULTICENTER CLINICAL OUTCOMES REGISTRY PROTOCOL Rochester, Minn.

    The purpose of this study is to allow the collection of demographic, treatment, and outcome data at sites in the United States for future analyses regarding the real-world use of MACI. Surgeons selected to participate in the MACI Registry will contribute participant outcomes to a centralized database for the purpose of analyzing and publishing these outcomes.
  • Meniscus Allograft Transplants Prospective Cohort Rochester, Minn.

    The purpose of this study is to assess the clinical outcomes of patients undergoing a MAT  procedure using patient-reported outcomes measures.

    We will be using data collected from IRB#15-000601 

     
  • Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial Of BioPoly® Partial Resurfacing Knee Implant For Treatment Of Focal Cartilage Lesions Of The Distal Femur Rochester, Minn. The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group.

    The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by:

    * no secondary surgical intervention (SSI) and
    * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points.

    Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement).

    Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.
  • SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures Rochester, Minn.

    The purpose of this study is to evaluate the effectiveness of SoftStitch™ for All-Inside Meniscal Repair of longitudinal tears on the posterior horn, and to observe improvement for ePROM and functional assessments of the knee at 24 months follow-up when compared to baseline.

    The secondary objective is to assess complications related to SoftStitch™, retears and repeated surgery. Structural healing of the meniscus will be evaluated at 6 months with MRI. Also, the safety profile of SoftStitch™ for All-Inside Meniscal Repair will be observed.

     

Closed for Enrollment

  • Center for Regenerative Medicine Allogeneic Cartilage Bank Rochester, Minn.

    The objectives of this study are to produce an allogeneic cartilage bank whereby cartilage tissue is obtained from consented donors who meet 21 CFR 1271 donor eligibility criteria, and to simluate clinical implantation of living donor osteochondral allografts banked from Aim 1, demonstrated to meet both viability and sterility requirements, in patients undergoing osteochondral transplantation in the Mayo clinical practice. Actual grafting using collected cartilage will not occur. This is a process validation study.
  • Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique Rochester, Minn.

    The results of this study will optimize the care for patients with a meniscus root tear. Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout technique is an effective treatment and will identify potential risk factors for poor clinical outcomes. In addition, investigators will determine if MRR is successful in delaying the radiographic progression of arthritis in the involved compartment.
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