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Clinical Trials

Research Graphic

Cartilage Restoration Center Research Team

Cartilage Restoration Center Research Team

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.

 

Ongoing Research Efforts

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.

Below is a brief description of our ongoing research efforts. If you believe you or your patients might qualify for one of our clinical trials or wish to be evaluated, please contact our research administrator, Kavita Ahuja, MD at (312) 563-2214 or [javascript protected email address] or inquire at your next visit.

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.


Multicenter Clinical Trials

The Subchondroplasty® Knee Randomized Controlled Trial

This is a multicenter, prospective, single-blinded, two-arm, randomized study. Enrolled subjects will have a single Bone Marrow Lesion of the tibia, single BML of the femur, or adjoining Bone Marrow Lesions of tibia and femur. Subjects will also be surgical candidates for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis. A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio.

The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.

Subjects will be enrolled within 60 days prior to surgery and take part in follow-up visits for two years following surgery. A preoperative visit will occur at the time of enrollment. Follow-up visits will occur at the study site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Telephone follow-up interviews will be done at 18 months post-surgery.

The Subchondroplasty® Knee Randomized Controlled Trial

 

Novartis Knee Injection for Cartilage Damage

This randomized controlled trial examines the use of an injection to regenerate articular cartilage in the knee in patients with cartilage defects. Click ‘here‘ to see the brochure and ‘here‘ to read more detail about the study.

 

GelrinC for the treatment of Articular Cartilage Defects in the Knee

This study evaluates the effectiveness of GelrinC in the treatment of cartilage damage in the knee. GelrinC is a synthetic material called PEG-DA combined with a natural protein called fibrinogen. Together, these materials form an implant which is inserted into the “hole” in your cartilage. As time goes on, new tissue forms around the implant and the implant gradually degrades so that eventually only the new tissue remains. This study hopes to find that the new tissue closely resembles your natural cartilage tissue, like the hole was never there in the first place.

Some patients with holes in their cartilage undergo a procedure called a microfracture, which stimulates the bone marrow within your knee bones to start the healing process. In this study, patients will have a microfracture procedure done with the additional implantation of the GelrinC. We will compare the results of the patients who received GelrinC to previous patients who only had the microfracture procedure. In an earlier clinical research study, GelrinC was shown to be safe for use and showed improvement in pain levels after surgery, symptoms and ability to do day to day activities.

Patients participating in the study answer questionnaires about their symptoms and functionality. Patients also undergo 4 MRI scans to evaluate how the knee is healing over the course of 5 years. There are 10 post-operative visits patients attend: 7 times within the first two years and then yearly at 3, 4 and 5 years.

Division I Track Athlete Undergoes Cartilage Regrowth Treatment

 

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.

NeoCart

 

Treatment Study for Articular Cartilage Injuries in the Knee

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: 

15052903

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:

  • Are able and willing to give informed consent.
  • Are 18 to 59 years of age.
  • Are symptomatic with knee pain indicative of an articular cartilage injury of the distal femur and/or trochlea.

This is a partial list of elgibility requirements.

Clinical Trial Area:

Orthopedic Conditions

Contact Phone:

(773) 257-7057

Contact Name:

Knee 1

 

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.

ACP (PRP) injections for the treatment of osteoarthritis of the knee trial

ACP Double Syringe System

Arthrex ACP® Autologous Conditioned Plasma Intra-Articular (IA) Injections for Knee Osteoarthritis (OA) Clinical Trial

Arthrex Autologous Conditioned Plasma (ACP) Intra-Articular (IA) Injections for Knee Osteoarthritis (OA) Clinical Trial

 

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

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.

MCID/PASS

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 SOS

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

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

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.

Midwest Orthopaedics

Youth Pitching Study: The Effect of a Strengthening Program

WHAT IS THE STUDY?

This study is examining the effect of a 6-week hip and core strengthening program on shoulder and elbow motion during pitching. Participants are 13-18 years old who pitch in at least one game per week on average during the season. Players will either be assigned to the control group or the strengthening program group. In the strengthening group, players will be taught a hip and core strengthening program and will be expected to complete it daily for 6 weeks. In the control group, players will continue to train as they were before enrolling in the study.

WHY HIP AND CORE STRENGTHENING?

The forces generated by the hip muscles during throwing are vital to the initiation and transfer of power to the arm. Electromyography (EMG) has shown that the legs and trunk provide rotational momentum for the arm and create over 50% of the total force and kinetic energy in a tennis serve. Other studies have shown that as a game progresses, players first show fatigue in their hip and core muscles and then lose their correct pitching form. In order to keep the same speed of their pitch while tired, players often use poor form and place themselves at risk for injury. We hope that using this conditioning program will strengthen the hip and core muscles and allow pitchers to continue pitching with proper form, therefore decreasing injuries.

WHAT WILL THE PLAYER BE EXPECTED TO DO?

When the player and parents decide to participate, the player will have baseline measurements taken, including hip range of motion, hip strength and the single leg squat test. Next, players will pitch while there are 1-inch markers attached to their arms and legs, which help us track body movements. If assigned to the strengthening group, players will be instructed on the proper completion of 10 exercises and will be instructed to do these daily before their regular practice sessions for 6 weeks. The program takes 10-15 minutes to complete. Players will also fill out a weekly compliance log of how often they do the exercises. The same tests will be repeated after the player has finished the 6 week program and then again after 6 months.

WHERE WILL THE TESTING TAKE PLACE?

The testing will take place at the new Rush University Medical Center Sports Training Facility in Oak Brook, IL.

WHAT ARE THE RISKS AND BENEFITS?

There is minimal risk associated with participating. Risks include injury from pitching, muscle soreness or discomfort associated with completing the hip and core strengthening program. Potential benefits include improvement in the players’ pitching mechanics and/or velocity. However, that result cannot be guaranteed.

Non-Multicenter Clinical Research

Use of Stem Cells in Osteoarthritis after Meniscectomy

Osteoarthritis (OA) is a common condition that can cause cartilage degeneration and require surgical intervention. One such intervention is a meniscectomy if a meniscal tear is present. This study seeks to understand the influence of stem cells in combination with meniscectomy as treatment for symptomatic meniscal tears in patients with OA. This will be done via the comparison of clinical outcomes in patients undergoing meniscectomy without stem cells versus patients undergoing meniscectomy with stem cells. As a randomized control clinical trial, 50% of patients receive the stem cell injection and 50% do not; patients are blinded as to which group they are enrolled. For patients receiving the injection, bone marrow aspirate will be drawn pelvic bone during surgery, spun down to concentrate the stem cells, and subsequently injected into the knee. Patients not receiving the injection will be “blinded” by receiving a small needle stick in the same area to mimic the bone marrow aspirate draw. In addition to patient reported clinical outcomes, synovial fluid is drawn from the knee during surgery as well as at several follow-up points in order to analyze the presence of inflammatory markers.

 

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

E-mail: [javascript protected email address]

Sarah Poland, Clinical Research Assistant:

Tel: (312) 432-2818

E-mail: [javascript protected email address]

 

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:

  • Long-Term (10 year) Outcomes of OA Grafts
  • Outcomes of OA Grafts Post-Microfracture Surgery
  • Outcomes of ACI Post-Microfracture Surgery
  • Outcomes of Patients Undergoing ACI Biopsy
  • Outcomes of Meniscal Transplant in Skeletally Immature Patients
  • Outcomes of ACI in Skeletally Immature Patients
  • Outcomes of OA Grafts in Skeletally Immature Patients
  • Incidence of Deep Vein Thrombosis after Knee Osteotomy

Other clinical knee research studies in progress:

  • Two-Year Follow-Up of Patients Undergoing Anterior Cruciate Ligament (ACL) reconstruction
  • The Effect of Cartilage and/or Meniscus Restoration upon Subsequent Knee Arthroplasty
  • Radiographic Analysis of ACL Femoral Tunnel Placement

Rotator Cuff Stem Cell Trial:

The use of stem cells has been shown to improve healing outcomes following rotator cuff repairs. Specifically, they have been shown to decrease the re-tear rate and provide more reliable healing rates. It is believed that stem cells might create a more favorable environment for tendon healing following repair.

The goal of this study is to compare the clinical outcomes of patients undergoing rotator cuff repair without stem cells to patients undergoing rotator cuff repair with stem cells. Since it is a randomized control clinical trial, 50% of patients receive the stem cell injection during surgery and 50% do not. Patients are blinded as to whether or not they were given stem cells. For patients receiving the injection, bone marrow aspirate will be drawn from the pelvic bone during surgery, spun down in a centrifuge to concentrate the stem cells, and subsequently injected into the rotator cuff repair site. Patients who do not receive the injection will be “blinded” by receiving a small needle stick in the same area, but no bone marrow aspirate will be drawn. Patients in the study complete pre-operative and post-operative surveys as well as complete an MRI 1 year post-operatively to evaluate tendon healing.

If you have shoulder pain due to a rotator cuff injury you may be eligible for a study on new treatments. The Stem Cell Trial is a new approach to the treatment of rotator cuff tears. To be eligible for the study, you must: have shoulder pain, be between ages 18 and 70, be willing to undergo initial evaluation and imaging to determine if your pain is caused by rotator cuff injury and be a candidate for surgical rotator cuff repair. If you are interested in this trial and wish to schedule an appointment for evaluation of your shoulder pain to find out if you are eligible for the Stem Cell Trial, please contact Midwest Orthopaedics: [javascript protected email address].

 

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:

  • Use of the Latarjet Procedure for Failed Instability Surgery
  • Clinical Outcomes of Split Pectoralis Major Tendon Transfer for Scapular Winging
  • Comparison of MRI vs CT for Glenoid Bone Loss
  • Clinical Outcomes of Humeral Head Osteochondral Allograft Transplantation
  • Outcomes of Rotator Cuff Repair in Patients Under 30 Years Old

Basic Science Studies

Implantation of Amniotic Membrane Allograft for Chondral Defect Healing in an Animal Model

This animal model compares traditional knee cartilage defect treatment to a novel amniotic membrane treatment. The purpose of this study is to determine the efficacy of amniotic membrane allografts in repairing chondral defects, with the hope that the outcomes will inform future treatments for cartilage defects. Twelve goats underwent surgery to create knee defects and were subsequently treated with either microfracture (surgical method which stimulates the bone marrow to produce growth factors and initiate healing) or an experimental amniotic membrane implant. Evaluation and biopsy of the defect was done at 6 months, and MRI of the goats was done at 1 year. Several factors are being considered in analysis of cartilage restoration, including degree of allograft incorporation into the native cartilage and overall stiffness of the cartilage. Analysis of the presence of inflammatory markers in blood and synovial fluid is also being conducted, with future analysis to study the concentrations of immunogenic inflammatory agents and cells responsible for cartilage matrix synthesis.

Recovery Effect of Normal Synovium

With the help of the Gift of Hope Organ Tissue Donor Network (Elmhurst, IL), ankle and knee tissue from 5 organ donors will be studied to compare the rate of recovery for various joint tissue treatments. Experimental groups include an untreated control group, an inflammatory tissue group, and a group that underwent mechanical cartilage manipulation. The impact of synovium on joint recovery is also being tested across these three groups. Thus, 50% of each group will be tested with synovium, and 50% will be tested without synovium. We are doing these experiments to determine how synovial fluid (the fluid in your joint) affects healing to determine if we can use it in the future to assist in your recovery.

Cytokine Analysis of Synovial Fluid in Cartilage Restoration

The purpose of this study is to understand the inflammatory environment of the knee after cartilage restoration procedures. To do so, synovial fluid from the knee joint is collected during cartilage restoration surgery and at three subsequent post-operative appointments. Concentrations of different inflammatory markers called cytokines are analyzed in this synovial fluid. The synovial fluid is also analyzed for the presence of; immunogenic cells (from your immune system) and cartilage restoring cells. The results of these analyses will help inform future therapeutic treatments for patients undergoing cartilage restoration procedures.

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:

  • Effects of Serial Sectioning and Repair on Lateral Meniscus
  • Arthroscopic Posterior Cruciate Ligament Repair: Phase II

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:

  • Determining Landmarks to Draw a Perfect Circle on the Glenoid
  • Comprehensive Management of Latissimus Dorsi and Teres Major Tendon Tears

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.

Brian J. Cole, M.D., M.B.A.

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