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Clinical Trials As part of the mission of the Rush Cartilage Restoration Center, orthopaedic surgeons at Rush are committed to providing patients with the full range of contemporary treatment options, including the latest minimally invasive procedures. Below is a brief description of a variety of ongoing research studies. If you would like more information about them, you can feel free to call the office or inquire about them at your next visit. All research studies have been approved by the Institutional Review Board at Rush-Presbyterian-St. Luke's Medical Center. Involvement in any fashion is purely elective and patients will undergo a thorough informed consent process. Patient information is strictly confidential and will only be used for research purposes. Knee Cartilage Restoration Prospective Studies: For patients scheduled to have one of the following procedures, we encourage you to participate in regularly scheduled follow-up visits (6-month, 1-year, 2-year, 3-year). Your progress will be carefully monitored through self-assessment and physical examination. Many of these procedures are relatively new, and prospective studies may contribute to the management of these and other related conditions.
Collagen Meniscus Implantation (CMI): The purpose of this study is to collect short and intermediate-term data on the effectiveness and safety of the collagen meniscus implant for patients with partial medial meniscal defects. The implant, sutured into the defect, acts as a scaffolding for the patient's own meniscal tissue to regenerate and fill the defect. Participants in this study will be randomly selected to receive either a meniscectomy or the collagen implant. Postoperatively, patients follow a prescribed rehabilitation protocol and are regularly evaluated for a two-year or five-year period of time. Early results are encouraging suggesting a significant amount of meniscus regeneration with a concomitant reduction in patient symptoms. Tissue engineering using chondrocytes: During anterior cruciate ligament (ACL) reconstruction, a "notch" or opening is created between the medial and lateral femoral condyle to prevent impingement of the newly constructed ACL. In order to create the notch, nonessential tissue (cartilage and bone fragments) is removed and normally discarded. In this particular study, we are inviting patients to donate these orthopaedic tissues so that researchers may be able to grow chondrocytes (cartilage cells) from the small samples that are donated. With these tissue culturing techniques, it is hoped that cartilage defects can be replaced with chondrocytes that are grown from the patient. The Effects of Heat on Tissue Radiofrequency Energy (RFE): During anterior cruciate ligament (ACL) reconstruction, a "notch" or opening is created between the medial and lateral femoral condyle to prevent impingement of the new ACL. In order to create the notch, nonessential tissue (cartilage and bone fragments) is removed, and bleeding and soft tissue elimination are controlled by one of three thermal devices (i.e., electrocautery, monopolar RFE, bipolar RFE. Electrocautery has traditionally been used, but this has been largely replaced by RFE devices. To date, no adverse events have been reported for this specific application with any thermal device. We are interested in evaluating the efficacy and safety of these thermal devices using pre- and postoperative magnetic resonance imaging (MRI) analysis. Testing of Articular Cartilage (diagnostic, debridement and lavage, meniscectomy, plica excision, etc.) Cartilage Stiffness Testing: A device to measure cartilage stiffness, the Artscan 200, can be inserted in preexisting arthroscopic portals. The probe will gently press on the articular cartilage surface to obtain stiffness measurements. Changes in cartilage stiffness precede visual degeneration, and the Artscan 200 may be used to predict osteoarthritis in patients prior to the actual manifestation of the disease. The test can be performed intraoperatively and will prolong the length of the surgery by only five minutes. There are no known risks associated with these studies. Normal cartilage: We are involved in a multicenter study attempting to map "normal" cartilage stiffness. It is hoped that the normal cartilage stiffness map will provide orthopaedic surgeons a standard by which patient cartilage stiffness can be measured. Mild degenerative changes: Recent studies have demonstrated that thermal chondroplasty with radiofrequency energy (RFE) can smooth the surface of mildly degenerative cartilage, and it is also thought that RFE may be able to stiffen articular cartilage. By smoothing and stiffening the cartilage surface, thermal chondroplasty may be able to slow the progression of osteoarthritis. In this study, we will compare cartilage stiffness before and after treatment with RFE. Shoulder Arthroscopic Rotator Cuff Repair Prospective Study: For patients scheduled to have arthroscopic rotator cuff repairs, we encourage you to participate in regularly scheduled follow-up visits (6-month, 1-year, 2-year, 3-year). Your progress will be carefully monitored through self-assessment and physical examination. This procedure is relatively new, and the prospective studies may contribute to the management of this and related conditions. Radiofrequency Energy (RFE): Arthroscopic rotator cuff repairs are usually performed in conjunction with a subacromial decompression to prevent impingement of the newly repaired rotator cuff. The undersurface of the acromion is shaved down, and one of three thermal devices (i.e., electrocautery, monopolar RFE, bipolar RFE) is used to control bleeding from the exposed bone and to eliminate soft tissue. Electrocautery has traditionally been used, but this has been largely replaced by RFE devices. We are interested in evaluating the efficacy and safety of these thermal devices using pre- and postoperative magnetic resonance imaging (MRI) analysis. Normal Shoulder Function: A survey is performed that includes subjective and objective data to quantify shoulder function. We believe that there are a few variables that may influence the outcome of the score, namely age, sex, and hand dominance. We are currently collecting data from patients with normal shoulders to create a database sufficient to describe normal shoulder function to better understand disease processes. Copyright 2001-2008 © Cartilagedoc.org, All Rights Reserved |
Cole Research Summary 2007