Clinical Trials

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.

Find more information here.

If interested, please contact:
Kavita Ahuja, MD at or [javascript protected email address]

ProChondrix CR

This is a multi-center, prospective, observational study evaluating the use of ProChondrix Cryopreserved Osteochondral Allograft for repair of articular cartilage defects on the femoral condyle and patella. The ProChondrix Cryopreserved Osteochondral Allograft is a laser-etched, allograft implant that is implanted in a single surgical procedure to the defected area of the knee.

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 ProChondrix Allograft.

If all inclusion and exclusion criteria are met, patients will be scheduled to undergo the procedure implanting the ProChondrix Allograft. After the procedure, the patient will follow-up and be evaluated seven times at: 3, 6, 12, 24, 36, 48, and 60 months. At these time points, the patient will also complete subjective surveys. These will be used to help determine a change in physical functioning and pain from their baseline.

ProChondrix CR Patient Brochure

Find more information here

If interested, please contact:
Kavita Ahuja, MD at   or [javascript protected email address]

Amniotic Suspension Allograft (ASA)

Amniotic suspension allograft (ASA) is an investigational, cryopreserved product derived from human amnion and cells from the amniotic fluid. It is thought that this kind of placental-derived product provide growth factors and cytokines that have anti-inflammatory properties, modulating symptoms of arthritis. Enrolled subjects will have mild to severe osteoarthritis of the knee joint. Prior to injection, subjects will undergo a screening period to assess all study criteria and the level of pain.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the use of ASA in patients with osteoarthritis of the knee. Patients meeting all criteria will be randomly assigned in a 1:1 ratio to receive either a single intra-articular injection of ASA or saline. For up to 52 weeks after receiving the injection, patients will follow up to assess knee pain, function, symptoms, and safety.

This study is active, but no longer enrolling new patients. For more information, please contact:
Kavita Ahuja, MD at   or [javascript protected email address]

Regentis GelrinC^®

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.

This study is active, but no longer enrolling new patients. For more information, please contact:
Kavita Ahuja, MD at or [javascript protected email address]

Division I Track Athlete Undergoes Cartilage Regrowth Treatment

www.wcax.com

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.

Find more information here.

This study is active, but no longer enrolling new patients. For more information, please contact:
Kavita Ahuja, MD at or [javascript protected email address]

Zimmer Subchondroplasty

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 postoperatively. Telephone follow-up interviews will be done at 18 months post-surgery.

Find more information here

This study is active, but no longer enrolling new patients. For more information, please contact:
Kavita Ahuja, MD at or [javascript protected email address]

Home vs. Physical Therapist Directed Rehabilitation for Reverse Total Shoulder Arthroplasty

Following reverse total shoulder arthroplasty, rehabilitation is crucial. There are many different ways to engage in rehabilitation, either at home or at a physical therapy studio, under the direction of a physical therapist or with the guidance of a surgeon. For reverse total shoulder arthroplasty, it is currently not known how physical therapy is best undertaken to minimize complications and maximize outcomes. For this reason, Dr. Cole is currently involved in a trial supported by a prestigious OREF research grant. This randomized, multicenter trial is studying physical therapy following reverse total shoulder arthroplasty. Patients are randomly selected to be in either a formal physical therapy group, in which they go to a physical therapist to learn exercises, or to a surgeon-directed home physical therapy group, in which patients learn exercises as part of the routine follow-up visits and do these exercises at home. Outcomes, range of motion, and complications will be recorded and compared between the two groups.

This study is active, but no longer enrolling new patients. For more information, please contact:
Shoulder Research Team, [javascript protected email address]

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 from the 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 2-weeks and 12-weeks postoperatively in order to analyze the presence of inflammatory markers.

If interested, please contact:
Dr. Cole’s Research Assistant, [javascript protected email address]

Effect of stem cells on osteochondral allograft outcomes

This randomized, controlled, blinded trial examines the effect of stem cells on patient outcomes after osteochondral allograft transplantation. Osteochondral allograft transplantation is performed in patients with cartilage defects in the knee. It is thought that the growth factors in stem cells can create a more favorable healing environment for integration of the graft into the patient’s knee. In this study, patients are randomized in a 1:1 fashion to either receive stem cells or not. In those who receive stem cells, bone marrow is harvested from the patient’s hip on the day of surgery and is processed into bone marrow aspirate concentrate, which contains stem cells. . 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. The graft is soaked in the stem cells and the remaining stem cells are injected into the cartilage defect. All patients undergo a CT scan at 6 months to evaluate integration. Patients also fill out questionnaires regarding their outcomes at 2 weeks, 6 weeks, 6 months, 1 year and 2 years post-operatively. Patients undergo aspirations of the knee pre-operatively on the day of surgery and post-operatively at 2-weeks, 6-weeks, 6-months and 1 year to evaluate the changes in the synovial fluid of the knee.

If interested, please contact:
Dr. Cole’s Research Assistant [javascript protected email address]

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

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

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 this study. The Stem Cell Trial is a new approach to the treatment augmentation 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 interested, please contact:
Dr. Cole’s Research Assistant, [javascript protected email address]

Comparison of Glenohumeral Injections for Osteoarthritis

Although frequently used in the treatment of osteoarthritis, platelet rich plasma (PRP) is currently considered an off-label use for shoulder osteoarthritis and is not covered by most health insurance plans. It is not known which type of injection will provide the most relief to patients with shoulder osteoarthritis. This study will investigate the effects of corticosteroid and PRP injections into the shoulder joint in providing symptomatic relief in patients with osteoarthritis of the shoulder.

This study is a randomized control trial comparing a single injection of corticosteroid and PRP for the treatment of primary glenohumeral osteoarthritis in patients. Patients will have a 50% chance of receiving a PRP injection at no cost. The other 50% of patients will be in the control group and will receive a corticosteroid injection. The enrollment period will be ongoing until a total of 100 patients per group are enrolled (50 patients per group). Patients will be blinded as to whether they receive the PRP or corticosteroid. For patients receiving the PRP injection, blood will be drawn in clinic and spun down to create the PRP, and subsequently injected into shoulder joint. For patients who receive the corticosteroid injection, they will undergo blood draw and 5 minute waiting period to simulate the normal PRP processing time and preserve patient blinding.

If you have a diagnosis of glenohumeral arthritis you may be eligible for this novel study investigating the efficacy of PRP. To be eligible for the study, you must: have a diagnosis of glenohumeral arthritis, be older than 18, have current shoulder pain, and be willing to undergo initial evaluation and subsequent study related follow up.

If interested, please contact:
Dr. Cole’s Research Assistant, [javascript protected email address]

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 to 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:

• Outcomes of Superior Capsular Reconstruction
• Use of the Latarjet Procedure for Failed Instability Surgery
• Outcomes after Shoulder Arthroplasty
• Clinical Outcomes of Humeral Head Osteochondral Allograft Transplantation

Cell Viability of Minced Cartilage

We are currently conducting a basic science laboratory study to assess the clinical viability of minced cartilage from donor knees used in osteochondral allograft transplantation. To do this, we are mincing cartilage left over after completing allograft transplantation and collecting it with an Arthrex Inc harvester named GraftNet^®. The samples are then taken to the lab where a number of analyses, including histology, live-dead staining, RNA analysis, and S35 radioactivity labeling are performed to assess the health and viability of the harvested cartilage cells. The cells are then maintained in a growth media for six weeks, after which the same analyses are performed again and compared to baseline. We are optimistic that this investigation will demonstrate the potential of minced cartilage as a viable modality for single-stage restoration of cartilage injury to the knee.

Sealant Ability to Remain in Various 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. It can be combined with a biologic, such as platelet-rich plasma or bone marrow concentrate, and autologous cartilage to augment microfracture and serve as an osteochondral allograft equivalent. This is sealed with a fibrin scaffold or autologous serum. However, the stability of various sealants with focal chondral lesions of different sizes and location is not known.

The purpose of this study is to conduct a basic science laboratory study to evaluate the ability of various sealants and BioCartilage^® to remain in the defect after microfracture procedures on chondral lesions of different sizes.

Cytokine Concentration Analysis

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 in patients 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.

Analysis of Subacromial Bursa for Stem Cells (study in preliminary phase)

Stem cells are currently being investigated for their promising ability to enhance healing in patients with a rotator cuff tear. The subacromial bursa is a soft tissue structure within the shoulder that is commonly removed and discarded during standard rotator cuff repair. The subacromial bursa may provide an abundance of stem cells that can help us understand the environment and cell interactions within the shoulder. This study will create the basis on which later studies may use these type of stem cells as a biologic treatment to improve patient rehabilitation after rotator cuff repair.

We are conducting a multicenter at Rush University Medical Center and University of Connecticut to study the stem cells and growth factors that inhabit the subacromial bursa of patients undergoing a shoulder arthroscopy procedure. The study includes using a specialized Arthrex Inc GraftNet^® tissue collecting device to collect soft tissue that is routinely removed and discarded during the procedure. This will in no way affect the standard of care treatment planned for the patient.