Back row (L to R) – Markus Wimmer, PhD; Adam Yanke, MD; Front row: (L to R) – Kavita Ahuja; Vincent Wang, PhD; Brian Cole, MD, MBA; Elizabeth Shewman, PhD; Susan Chubinskaya, PhD.
Last Updated: October, 2015
As part of the mission of the Division of Sports Medicine, Section of Shoulder and Elbow Surgery, and the Rush Cartilage Restoration Center, orthopedic surgeons at Midwest Orthopaedics at Rush are committed to providing patients with the most complete range of contemporary treatment options, including the latest minimally invasive procedures. In its 17th year under the direction of Dr. Brian J. Cole, MD, MBA, we have collected data and reported on more than 1,000 transplants and cartilage repair procedures. These publications and the rehabilitation protocols are available in the Resource Library.
All research studies have been approved by the Institutional Review Board at Rush University 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.
NeoCart tissue implant for the treatment of articular cartilage injuries in the knee
This is a company-sponsored Phase 3, randomized research study evaluating an investigational treatment called NeoCart®, a tissue implant made from a patient’s own cells, aimed at repairing certain knee cartilage injuries. The study will look at damage to the knee’s hyaline articular cartilage, the smooth, white tissue that covers the ends of bones where they come together to form joints. Damage to this cartilage may be caused by an injury or repetitive motion. It is a common problem that results in pain and symptoms, such as swelling, locking of the knee and loss of knee function. Damaged hyaline cartilage has limited capacity to repair or restore itself. Left untreated, the damage may progressively worsen and may lead to chronic conditions such as osteoarthritis. The purpose of this study is to learn about the safety and potential efficacy of the investigational cartilage tissue implant, NeoCart®, compared to microfracture, the current standard of care surgery for articular cartilage defects of the knee.
Patients who are between 18 and 59 years old and who have symptoms of pain in one knee may be candidates for this study will be screened for study recruitment. Accepted patients will have a two out of three chance of being treated with NeoCart® and a one out of three chance of receiving the microfracture procedure. Patients in each group will know their treatment group, have a specific rehabilitation program, and be evaluated periodically for three years after treatment.
The study sponsor is Histogenics, Corp. For more information, text knee1 to 87888, call (773)257-7057 or visit www.NeoCartImplant.com.
Clinical Trial Title:
A randomized comparison of NeoCart to microfracture for the repair of articular cartilage injuries in the knee: Phase III / confirmatory study.
Clinical Trial Protocol ID:
Clinical Trial Investigator Name:
Brian J. Cole, MD, MBA
Clinical Trial Protocol Description:
The purpose of this company-sponsored Phase 3 study is to learn about the safety and potential efficacy of the investigational cartilage tissue implant, NeoCart®, compared to microfracture, the current standard of care surgery for articular cartilage defects of the knee. A total of 245 patients will participate in the NeoCart clinical trial in up to 40 sites across the United States.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
This is a partial list of elgibility requirements.
Clinical Trial Area:
ACP (PRP) injections for the treatment of osteoarthritis of the knee trial
ACP (autologous conditioned plasma) is a substance with remarkable healing properties derived from blood and used to treat injuries and arthritis. ACP contains a concentrate of growth factors and platelets which signal a reparative process when injected into damaged tissue. A small quantity of blood is required for the procedure which is drawn into a specialized double syringe system and then spun in a centrifuge machine until plasma rich in platelets and growth factors is isolated. This plasma is then drawn out and injected into the affected joint to promote healing. The entire procedure takes about 30 minutes to perform. You may receive three treatments a week apart. ACP is a new treatment currently being researched. Your doctor will explain the procedure and the risks involved before obtaining your consent.
Adipose Derived Regenerative Cells (ADRC Trial): Stem Cell Trial for Knee Osteoarthritis
This is a randomized, double-blind, placebo controlled trial in 90 patients evaluating the efficacy and safety of ADRC’s autologous adipose stem cell therapy. ADRC’s, have the potential to improve the course of the disease by potentially reducing inflammation, improving restoration of blood flow and stimulating local repair cells. The study involves a small liposuction procedure on the abdomen or thigh followed by processing of the fat tissue the same day to prepare the stem cell suspension. The suspension is then injected into the symptomatic arthritic knee the very same day. The trial will be conducted over 48 weeks. Randomization is: 2 (ADRC): 1 (Placebo). Assessments will include pain, joint function, magnetic resonance imaging and adverse events.
CARTISTEM® is composed of umbilical cord blood-derived stem cells (also called Mesenchymal Stem Cells or MSCs) and sodium hyaluronate. The MSC is isolated from the umbilical cord blood of a screened donor, expanded in vitro, and cryopreserved into a drug substance. Sodium hyaluronate is similar to the fluid that surrounds joints, and makes the CARTISTEM® the consistency of a gel, so that it can be administered into the knee.
The primary objective of this phase I/IIa study is to evaluate the safety and efficacy of CARTISTEM® in patients with articular cartilage defects ranging in size from 5 cm2 and larger. In this study, subjects with articular cartilage injuries or defects are given one dose of CARTISTEM® into the knee. CARTISTEM® is surgically implanted through a small incision. This study is not for osteoarthritis where there are bone-on-bone changes in the knee.
Male and non-pregnant female patients between 18 and 55 years of age are screened for study recruitment. This is a two-year study and clinical evaluations with be performed preoperatively and postoperatively at weeks 2, 4, 8 & 12, and months 6, 12, and 24. Pre and postoperative radiographs, MRIs and blood work will be performed.
Cartilage Defect Progression Longitudinal Study
The objective of this clinical investigation is to comprehensively characterize histologic progression and gene expression changes of cartilage defects following routine surgical debridement. This study examines cartilage harvested from autologous chondrocyte implantation (ACI) candidates routinely debrided at the time of biopsy and collected subsequently during routine defect preparation immediately prior to chondrocyte implantation or an alternate follow-up procedure.
Male and female patients between 15 and 55 years of age are screened for study recruitment. Patients undergoing an ACI biopsy must return within 9 month of their initial procedure for implantation or alternative follow-up surgical procedure.
This is a prospective multicenter longitudinal cohort study conducted at tertiary care centers across North America. The purpose of this study is to determine the ‘minimal clinically important difference’ (MCID) and the ‘patient acceptable symptomatic state’ (PASS) of two questionnaires: the Knee Injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee (IKDC) Subjective Knee Form. This study is focused on patients undergoing surgery for articular cartilage defects of the knee. Possible surgical interventions may include debridement, shaving, drilling, microfracture, osteochondral autograft/allograft transfer, autologous chondrocyte implantation or DeNovo NT. The aforementioned procedures can be performed in isolation or combined with a meniscal transplantation and/or peri-articular knee osteotomy in a single operative setting.
Male and female patients between 18 and 55 years of age are screened for study recruitment. This is a two-year study and patients will complete questionnaires pre- and post-operatively at 6, 12, 24 months.
BioCartilage® is a dehydrated micronized cartilage allograft designed to provide a reproducible method to augment traditional microfracture procedures. BioCartilage is combined with a platelet rich plasma to create a scaffold for a properly prepared cartilage defect in conjunction with a bone marrow stimulation technique. Scientific evidence exists supporting the premise that a dehydrated, allograft cartilage scaffold used as an adjunct to microfracture should improve the degree and quality of tissue-healing within an articular cartilage defect when properly prepared.
The purpose of this study is to collect observational data to determine the clinical outcomes associated with the use of BioCartilage across a broad provider network. Outcomes will be compared to historical microfracture peer-reviewed published data.
Male and non-pregnant female patients between the ages of 18 and 55 are screened for study recruitment. Preoperatively, and at 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively, subjects will be requested to complete pain, health and function surveys using the Surgical Outcomes System (SOS) registry web based program.
DeNovo® NT (Natural Tissue) is a human tissue allograft consisting of particulated juvenile articular cartilage intended for implantation at the lesion site with the help of fibrin adhesive. Chondrocytes within the DeNovo NT implant clone, divide and produce matrix leading to defect fill and peripheral integration. The Denovo NT Graft is surgically implanted and affixed to subchondral bone using commercial fibrin during a mini-open knee arthrotomy.
This is a post-market, multicenter study of the commercially-available DeNovo NT graft. Patients will be enrolled either prospectively or retrospectively. Only patients who receive or have received one or more DeNovo NT implant(s) may participate.
Preoperative, operative and postoperative procedures and evaluations will be completed according to routine care. Data will be collected on the details of these procedures and evaluations and the graft used. Follow-up data will be collected at 6 months, 12 months, 18 months, and 2, 3, 4, and 5 years following the surgical event.
NOVOCART® 3D Autologous Chondrocyte Transplantation System, a cell-scaffold biologic/device combination product composed of ex vivo expanded autologous chondrocytes seeded on a bioresorbable biphasic collagen scaffold implanted using a minimally invasive approach. The biphasic scaffold consists of a covering collagen membrane and a cell-carrying collagen sponge.
The purpose of this FDA Phase III clinical study is to demonstrate the superior efficacy of the Novocart® 3D autologous chondrocyte transplantation system compared to microfracture in the treatment of articular cartilage defects of the knee in patients who have had inadequate response to conservative treatment. Subjects will be randomized to one of the two study arms. Arm 1: The control therapy, microfracture, is a proven therapy considered to be the current standard of care. Arm 2: The Novocart 3D procedure requires two surgeries: 1) evaluation of articular defect and harvest of cartilage biopsy; 2) preparation of defect and implant of Novocart® 3D. The implant surgery utilizes an approach through a mini-arthrotomy.
The follow-up visits will take place at 2 weeks, 3, 6 and 12 months and then every 6 months through 5 years after the procedure. During the visits clinical and subjective evaluations, knee MRI, x-rays and blood work will be performed.
The enrollment for this study is expected to start in November 2014.
Meniscal Tear with OA Research (MeTeOR)
Significant controversy remains about the short- and long-term benefits of mensicetomy performed in a setting of concomitant arthritis. Rush University Medical Center is part of a multi-center NIH funded study investigating this problem. This is a randomized controlled trial of arthroscopic partial meniscectomy (APM) versus a standardized non-operative management program among patients (age 45 or above) for patients with symptomatic meniscal tear in the setting of concomitant knee osteoarthritis.
Enrollment for this study is closed. Participants are being followed for five years.
Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
This randomized clinical trial is investigating the effect of mesenchymal stem cells on the progression of knee osteoarthritis in patients undergoing meniscectomy. In this study, half of patients will receive stem cells in addition to meniscectomy. Patients will be followed throughout their recovery process and monitored for the development and progression of arthritis in the knee joint through physical examination, MRI, X-rays, and synovial fluid analysis. Patients will come in for follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.
An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients with Osteoarthritis
ReNu is a randomized injection trial for patients with moderate knee osteoarthritis as determined by a combination of clinical and radiographic findings. Specifically, ReNu is an intra-articular injection of amniotic membrane and amniotic fluid cells, which have shown the potential to decrease inflammation and increase tissue healing in osteoarthritic patients. This trial will investigate the efficacy of this injection through a combination of patient-reported outcomes, physical exams, x-rays, and laboratory testing. Following the injection, patients will have follow-up visits at 1 week, 6 weeks, 3 months, 6 months, and 12 months. All patients participating in this trial will be randomized to receive ReNu, Hyaluronic, or a saline injection.
If interested please contact:
Kavita Ahuja, Clinical Trial Coordinator:
Tel: (312) 563-2216
Sarah Poland, Clinical Research Assistant:
Tel: (312) 432-2818
HA vs. PRP: A double-blind prospective randomized controlled trial comparing clinical outcomes and intra-articular biology for the treatment of knee arthritis
Orthopedic surgeons have tried to identify efficient non-invasive treatment options for articular cartilage lesions of the knee to improve patients’ quality of life, prevent further joint degeneration, and delay invasive procedures. Hyaluronic acid (HA) is currently utilized as an intra-articular injection for treatment of patients with knee osteoarthritis. It is proposed that platelet-rich plasma (PRP) is a biologic alternative to HA that may alter the intra-articular biologic milieu to better mitigate the symptoms of osteoarthritis.
The purpose of this double-blind prospective randomized clinical trial is to compare the effects of PRP to HA for the treatment of OA in the knee using validated clinical outcome measures and biologic correlates associated with osteoarthritis.
Enrollment for this study is closed. Data analysis is currently underway.
Cartilage Restoration Prospective Studies
Patients scheduled to have a cartilage restoration procedure (autologous chondrocyte implantation (ACI), osteochondral autograft or allograft transplantation (OA), or meniscal transplantation) are encouraged to participate in regularly scheduled follow-up visits (6-month, 1-year, 2-year, 3-year). Progress is carefully monitored through self-assessment and physical examination. Several studies related to these procedures are underway for us to understand how to treat patients most effectively:
Other clinical knee research studies in progress:
Rotator Cuff Stem Cell Trial:
Randomized Prospective Analysis of Arthroscopic Suprapectoral and Open Subpectoral Biceps Tenodesis
The optimal treatment of patients with painful biceps pathology is unclear. One method, tenotomy, can lead to cosmetic deformity and anterior humeral discomfort from spasms, causing many surgeons to perform an alternate procedure, tenodesis. Tenodesis includes intra-articular soft tissue fixation or osseous fixation, suprapectoral osseous fixation, and subpectoral osseous fixation. The clinical or surgical benefit of performing an open subpectoral versus arthroscopic suprapectoral biceps tenodesis is not known.
The purpose of this prospective study is to determine the superiority of either arthroscopic suprapectoral or open subpectoral biceps tenodesis with regard to various clinical variables.
Male and non-pregnant female patients will be screened for study recruitment. Preoperatively, and at 3, 6, and 12 postoperatively, subjects will be requested to complete pain, health and function surveys and undergo clinical assessments.
Enrollment for this study is expected to begin in November 2014.
Distal Tibia Allograft for Glenoid Bone Loss
Bony reconstruction of the glenoid in the setting of shoulder instability is challenging, especially in cases where traumatic force has displaced more than 20% of the glenoid. Several variations of bone grafts are used to add more glenoid area for these patients. A more recent method developed at Rush involves the using a fresh osteochondral distal tibial allograft. The curvature of the bone matches well to the glenoid making it appropriate for use as a graft, and the distal tibia has cartilage that may benefit the shoulder joint.
The purpose of this retrospective study is to compare clinical outcomes of patients who have received a distal tibia allograft to those of patients who have been treated using other bony reconstruction methods.
Normal Shoulder Function Database
Participants complete a survey of subjective and objective data to quantify shoulder function. The purpose of this study is build a database sufficient to describe normal shoulder function and to better understand disease processes.
Patient enrollment and data collection is ongoing from patients with healthy shoulders.
Other current clinical shoulder studies:
Comparison of Fixation Methods for Repair of Lateral Tibial Plateau Fractures during Medial Opening Wedge High Tibial Osteotomy (HTO)
High tibial osteotomy (HTO) is a commonly used and accepted treatment of medial unicompartmental osteoarthrosis in the presence of axial malalignment. HTO can be performed medially or laterally. When performed medially, lateral tibial plateau fractures are a challenging and serious complication of an HTO.
The purpose of this study is to determine the rotational and torsional instability that occurs upon a fracture of the lateral tibial plateau during a medial opening HTO, to compare different implants on fixation of the fracture and restoration of joint congruity, and to compare rotational and torsional instability with an implant upon repair of a lateral tibial plateau fracture after medial opening HTO. Data is currently being collected for this study.
Fibrin Ability to Stay in Different Sized Articular Cartilage Defects of the Knee
There are a number of surgical procedures that can be used to address osteoarthritis and focal chondral defects of the knee, including microfracture, autologous chondrocyte implantation, debridement, osteochondral allografts or autografts, and knee replacement. In the case of microfracture, scaffold can be applied over the defect to supplement bone marrow stimulation. BioCartilage® (BioCartilage® Micronized Cartilage Matrix, Arthrex, Inc., Naples, Florida) is a scaffold device that has shown promising results. However, the stability of various fibrin scaffolds with focal chondral lesions of different sizes and location is not known.
The purpose of this study is to evaluate the ability of fibrin scaffolds and BioCartilage® to remain in the defect after microfracture procedures on chondral lesions of different sizes.
Meniscus Allograft Transplantation: Ability to Alter the Native Insertion and Maintain Native Biomechanical Properties
Meniscal allograft transplantation (MAT) is a current treatment for meniscal deficiency. One widely used MAT technique, the bone bridge technique, has been criticized for not allowing the surgeon to match the donor graft attachment to the native anterior and posterior horn insertions. The purpose of the meniscus is to distribute body forces more evenly across the knee, however, an improperly-sized meniscus will not disperse body weight properly.
The purpose of this study is to investigate the difference in contact pressure between correctly-sized menisci and incorrectly-sized menisci whose horn location has been adjusted to match the recipient in the MAT.
Additional basic science studies related to the knee:
Subpectoral Biceps Tenodesis with PEEK Interference Screw: A Biomechanical Analysis of Fracture
Biceps tenodesis is a commonly accepted surgical option for pathology related to the long head of the biceps. Sub-pectoral tenodesis with an interference screw offers reproducible outcomes with high biomechanical strength allowing for accelerated rehabilitation. However, there is concern regarding potential fracture risk associate with the diaphyseal humeral tunnel created by the screw, particularly in an athletic population.
The purpose of this study is to determine the amount of torsional strength reduction in the humerus resulting from an unicortically drilled hole and to evaluate the effect of inserting a tenodesis screw into the drilled defect.
Biomechanical Analysis of Latarjet Screw Fixation: Comparison of Fully Threaded, Partially Threaded, and Cannulated Screws
The Latarjet coracoid transfer procedure has become the gold standard treatment in the management of anterior glenohumeral instability with significant bone loss. The incidence of recurrent dislocation after the Latarjet procedure is reported to range from 1% to 5%, and screw selection in the Latarjet procedure has largely been based on surgeon preference. There are no previous biomechanical studies that compare different screw type fixation strength.
The purpose of this biomechanical study is to determine the strongest screw construct to provide the greatest initial stability in the Latarjet procedure and prevent recurrent dislocation.
Additional basic science studies related to the shoulder:
The above is only an abbreviated list of ongoing research performed by Dr. Cole and the Midwest Orthopedics at Rush research team. These research efforts are dynamic and continually growing to promote the development of knowledge that will improve patient care. If you are interested in supporting these research efforts, please consider an important donation that can be completed through www.rush.convio.net/goto/liveactiveresearch.