Orthopedic Surgery Clinical Trials | NYU Langone Health

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Department of Orthopedic Surgery Research Orthopedic Surgery Clinical Trials

Orthopedic Surgery Clinical Trials

The Department of Orthopedic Surgery at NYU Langone aims to provide patients with the very best in individualized care, whether their conditions are simple or complex. Our ability to do this relies heavily on the clinical trials we conduct. The results of these trials help guide efficient and appropriate patient care.

Our location in New York City gives our researchers access to diverse patient populations and the ability to conduct clinical trials in all of the major orthopedic subspecialties. If you are thinking about enrolling in a trial or study, you and your doctor can discuss whether doing so is an appropriate option. Please also consult our resources for prospective and current study participants.

We are currently conducting clinical trials in the following orthopedic subspecialty areas:

Some of our trials are long-term follow-up studies that are closed to enrollment.

Adult Reconstructive Clinical Trials

Our adult reconstructive clinical trials focus on a wide range of issues in joint replacement.

Antibiotic Prophylaxis in Patients Undergoing Elective TKA—Multicenter Trial

The purpose of this study is to compare different perioperative antibiotic administration protocols with regard to surgical site infection or periprosthetic joint infection rates in elective total knee arthroplasty, also known as TKA. The investigator is Ran Schwarzkopf, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245. See full clinical trial information. This study is sponsored by Duke University.

Antimicrobial Barrier Dressing Versus Closed-Incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty

The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or a portable negative pressure wound dressing is superior in preventing wound complications and infections in obese patients having total joint arthroplasty. All patients with a body mass index (BMI) greater than 35 having total joint arthroplasty are eligible. Patients with an active infection and previous scar or wound-healing complication are ineligible. The investigator is William J. Long, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245. See full clinical trial information.

Closed Incision Negative Pressure Therapy Versus Standard-of-Care Surgical Dressing in Revision Total Knee Arthroplasty (PROMISES)

The purpose of this study is to evaluate surgical site complications in subjects having a revision of a failed total knee arthroplasty, or TKA, when closed incision negative pressure therapy is used to manage the closed incision, as compared with standard-of-care dressing. The investigators are William J. Long, MD; Patrick A. Meere, MD; Ran Schwarzkopf, MD; and James D. Slover, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by KCI USA, Inc.

Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement (PEPPER)

The purpose of this study is to determine the most effective postoperative anticoagulant medication. Patients having unilateral total hip or knee replacements are eligible unless they are unable to take Coumadin®, Xarelto®, or aspirin. The investigator is James D. Slover, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245. See full clinical trial information.

Comparing Pain-Related Outcomes in Patients with and without Tourniquet in Total Knee Arthroplasty

The purpose of this study is to identify differences of pain and discomfort in patients who receive total knee replacement with or without a tourniquet. The investigator is Ran Schwarzkopf, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245.

Engaging Patients and Community Members in Managing and Treating Osteoarthritis—Tier III

The purpose of this study is to bring together diverse stakeholders—patients, patient advocacy groups, researchers, and clinicians—to develop the capacity and infrastructure to conduct patient-centered research on the management and treatment of symptomatic hip and knee osteoarthritis. The infrastructure is used to discuss research areas of great importance to patients, identity individuals with whom to collaborate, strengthen communication channels, and understand the various parties’ perspectives. The investigator is Raj J. Karia, MPH.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245. This trial is sponsored by the Patient-Centered Outcomes Research Institute.

Evaluation of Preoperative N1539 in Total Knee Arthroplasty

The purpose of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects having open unilateral total knee arthroplasty, or TKA, compared with placebo. The investigator is William J. Long, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by Recro Pharma, Inc.

JOURNEY II XR Safety and Effectiveness PMCF

The purpose of this study is to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants receive the JOURNEY II XR total knee system. The investigators are Ran Schwarzkopf, MD, and Ivan Madrid, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by Smith & Nephew, Inc.

Knee Osteoarthritis Pre-/Post-Bariatric Surgery and Medical Weight Loss Biomarker Study

The purpose of this study is to evaluate knee osteoarthritis and associated knee pain in patients who are either planning to have weight loss surgery or who are enrolled in a monitored program at NYU Langone’s Weight Management Program. To qualify for this study, you must have pain in at least one of your knees for at least a month. Participation in this study lasts approximately two years, but all research visits are performed before or after your regularly scheduled appointments with your physician at our bariatric clinics. Participants are not compensated for this study. The investigator is Jonathan Samuels, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245.

LEGION Hinge Safety and Efficacy Study (LINKS)

The purpose of this study is to evaluate how well the LEGION Hinge Knee system performs over a five-year period by collecting clinical, radiographic, and participant-reported outcomes. The investigators are Ran Schwarzkopf, MD; James D. Slover, MD; Ivan Madrid, MD; and Scott E. Marwin, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by Smith & Nephew, Inc.

Long-Term Multicenter Evaluation of E1 Antioxidant Infused Technology and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes

The purpose of this study is to document the 10-year radiographic and clinical outcomes of the E1® Antioxidant Infused Technology, a new type of highly cross-linked polyethylene liner that contains vitamin E as an antioxidant, in a group of primary total hip arthroplasty patients. The investigator is James D. Slover, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. This trial, currently in long-term follow-up, is sponsored by Zimmer Biomet.

Manipulation Under Anesthesia with NSAIDs and Corticosteroids as an Adjunct for the Management of Arthrofibrosis Following Total Knee Replacement

The purpose of this study is to evaluate whether manipulation under anesthesia (MUA) with and without a single dose of dexamethasone and a two-week course of the nonsteroidal anti-inflammatory drug (NSAID) celecoxib raises function scores. Patients who received a total knee replacement for osteoarthritis who are scheduled for MUA 6 to 10 weeks postoperatively are eligible for the study. Patients who cannot tolerate NSAIDs or who have renal dysfunction or rheumatoid arthritis are ineligible for the study. The investigator is William J. Long, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245.

Measuring Physical Activity After Total Joint Arthroplasty by Using a Wearable Activity Tracker

The purpose of this study is to evaluate and compare the level of physical activity and sleep quality using a Fitbit Flex device in patients having total joint arthroplasty. Any patient over 18 years of age who is receiving a total knee or hip replacement is eligible. The investigator is Ran Schwarzkopf, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245.

Mechanics and Performance of Traceable Ultra High Molecular Weight Polyethylene Implants

The purpose of this study is to further our understanding of the material property changes that occur with polyethylene components used in total hip or knee arthroplasties by post-processing of used implants during revision procedures. The investigator is Ran Schwarzkopf, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245.

Multicenter, Randomized Controlled Study of Efficacy and Safety of an Investigational Total Hip Replacement System in Subjects with Noninflammatory Arthritis

The purpose of this study is to investigate the safety and efficacy of an investigational total hip replacement system. The study follows enrolled subjects for 730 days for the primary endpoint analysis and 10 years (extended follow-up) in total. Participants meeting inclusion and exclusion criteria will receive total hip arthroplasty and will be randomized to receive implantation of the investigational or control device. The postoperative rehabilitation will be per standard of care at the treating institution. The investigators are Ran Schwarzkopf, MD, and James D. Slover, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. This trial is sponsored by Smith & Nephew, Inc.

Navio with Total Knee Arthroplasty

The purpose of this study is to compare how the robotic-assisted Navio Surgical System performs in achieving postoperative mechanical alignment within acceptable range of neutral as compared with standard instruments in total knee arthroplasty (knee replacement). The investigators are Ran Schwarzkopf, MD, and Ivan Madrid, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, currently in long-term follow-up, is sponsored by Smith & Nephew, Inc.

Preventing Smoking Relapse After Total Joint Replacement Surgery

The purpose of this study is to compare the effectiveness of standard postoperative cessation treatment with a comprehensive relapse prevention intervention on smoking cessation outcomes. The investigator is Scott E. Sherman, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245.

Post-Market Clinical Follow-up Study of the REDAPT Monolithic Sleeveless Stem and Acetabular Components Devices Used for Hip Replacement Surgery

The purpose of this study is to assess the safety and performance of the REDAPT Revision Femoral System monolithic stem and acetabular cup by following the outcomes of the revision hip replacement up to a 10-year period. The investigators are Ran Schwarzkopf, MD, and James D. Slover, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by Smith & Nephew, Inc.

A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications

The purpose of this study is to determine the efficacy of the experimental zipper surgical skin closure device in reducing wound complications and costs in total joint arthroplasty. All patients having total joint arthroplasty are eligible. The investigator is Ran Schwarzkopf, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Daniel Waren, MSPH, CCRC, senior clinical research coordinator, at daniel.waren@nyulangone.org or 212-598-6245. See full clinical trial information.

TSolution One Total Knee Arthroplasty

The purpose of this study is to evaluate the safety and efficacy of robotic-assisted total knee arthroplasty with the TSolution One® total knee arthroplasty device. The investigator is William J. Long, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, currently in long-term follow-up, is sponsored by Think Surgical, Inc.

Foot and Ankle Clinical Trials

Our foot and ankle clinical trials include the following.

Two-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR 2 PAS)

The purpose of this study is to examine the performance of the STAR Ankle under actual conditions of use. Subjects who have been diagnosed with at least primary arthrosis, post-traumatic arthrosis, or rheumatoid arthritis have the problematic bone and tissue removed and the STAR Ankle inserted. The investigators are Kenneth J. Mroczek, MD; Steven Sheskier, MD; and Cary Chapman, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, currently in long-term follow-up, is sponsored by Stryker GmbH.

Orthopedic Trauma Clinical Trials

Our orthopedic trauma clinical trials include the following.

Study Evaluating CERAMENT|G in Open Diaphyseal Tibial Fractures

The purpose of this study is to determine whether a resorbable bone filler with antibiotic, called CERAMENT®|G, is safe and effective in promoting bone healing and preventing infection in people with open (exposed bone) fractures of the tibia, as compared with standard surgical and medical care. The investigators are Philipp Leucht, MD, PhD; Nirmal C. Tejwani, MD; and Toni M. McLaurin, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by BONESUPPORT AB.

Shoulder and Elbow Clinical Trials

We are currently conducting the following shoulder and elbow clinical trials.

Open-Label, Multicenter, Retrospective/Prospective Evaluation of Shoulder Arthroplasty

The purpose of this study is to collect and evaluate clinical and radiographic information on patients who have had, or will have, shoulder joint replacement surgery. Only subjects who receive a legally marketed shoulder replacement device, such as the Equinoxe Shoulder System, as part of their shoulder surgery are included in this study. The investigators are Young W. Kwon, MD, PhD, and Joseph D. Zuckerman, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. This trial is sponsored by Exactech, Inc.

Rotator Cuff–Sparing Total Arthroplasty

The purpose of this study is to collect and evaluate long-term clinical data on patients whose total shoulder arthroplasty (TSA) is performed using the traditional surgical approach, known as the subscapularis release approach, as compared with patients who have a TSA procedure performed using a newer surgical approach, known as the rotator cuff–sparing approach. The investigators are Young W. Kwon, MD, PhD, and Joseph D. Zuckerman, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information.

Spine Clinical Trials

Our spine clinical trials are as follows.

Cervical Patient-Generated Index

The purpose of this study is to develop a new way to evaluate patients’ goals and expectations before spine surgery to help surgeons deliver more effective therapies and education regarding treatment plans. Study procedures include collecting clinical, radiographic, and participant-reported outcomes over a two-year period. The investigators are Themistocles Protopsaltis, MD, and Aaron J. Buckland, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org.

Comparing Clinical Photographic Imaging with Radiographic Imaging in Diagnosing Spinal Deformity

The purpose of this study is to assess the clinical accuracy, relevance, and utility of digital photographic imaging in measuring spinal alignment and curvature. We hope to accurately diagnose operative and nonoperative disease in adults with spinal deformity without the use of expensive radiographic forms of imaging. Study procedures include collecting clinical data and radiographic and photographic images of the patients’ spines over a one-year period. The investigators are Themistocles Protopsaltis, MD, and Aaron J. Buckland, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org.

The Confounding Burden of Psychological Impairments in Cervical Spine Surgery

The purpose of this study is to understand the relationship between psychological distress and clinical outcomes in patients who experience neck pain and radiculopathy after having surgical treatment for cervical degenerative disease. We also seek to determine the effectiveness of a brief psychological intervention in a subset of patients who screen positive for psychological distress before their surgeries, and treat those patients with therapy six times before surgery. All enrolled patients are followed postoperatively during regularly scheduled clinic visits over a two-year period. The investigators are Peter G. Passias, MD; Sherri Weiser-Horwitz, PhD; Marco Campello, PhD, PT; John A. Bendo, MD; Aaron J. Buckland, MD; Charla R. Fischer, MD; Michael C. Gerling, MD; Jeffrey A. Goldstein, MD; Anthony M. Petrizzo, DO; Themistocles Protopsaltis, MD; and Jeffrey M. Spivak, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org. See full clinical trial information.

Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery

The purpose of this study is to assess the efficacy and safety of tranexamic acid using a dosage regimen similar to that used in the currently approved indication (intravenous therapy of patients with hemophilia during and following tooth extraction) for the reduction of blood loss and minimizing transfusion rates in patients having spinal fusion surgery. The investigators are Aaron J. Buckland, MD; Themistocles Protopsaltis, MD; and Charla R. Fischer, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org.

Prospective Database Registry Study of Scoliosis in Children with Cerebral Palsy

The purpose of this study is to understand how to best treat scoliosis in patients with cerebral palsy and to determine which surgical interventions are most beneficial for these patients. Study procedures include collecting data on clinical, radiographic, and caregiver-reported outcomes over a two-year period. The investigator is Aaron J. Buckland, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org.

Prospective, Multicenter Adult Spinal Deformity Outcomes Database Registry (PON)

The purpose of this study is to create a registry to better understand the outcomes of patients with adult spinal deformity who are treated either operatively or nonoperatively. Study procedures include collecting clinical, radiographic, and patient-reported outcomes over a two-year period. The investigators are Themistocles Protopsaltis, MD; Aaron J. Buckland, MD; Charla R. Fischer, MD; and Peter G. Passias, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org. See full clinical trial information.

A Prospective Study of Global Alignment and Dynamic Motion of Operative Kyphoscoliosis for the Preservation of Motion and Function

The purpose of this study is to investigate the motion of the spine, head, body, arms, and legs in patients with scoliosis before and after surgery, and to understand what aspects of surgery allow for the best long-term range of motion. Study procedures include collecting clinical exam information, radiographic images, and two-dimensional video, and performing a three-dimensional gait analysis over a two-year period. The investigator is Anthony M. Petrizzo, DO.

For more information about participating in this trial, including additional eligibility criteria, contact Dr. Petrizzo at 516-735-4048.

Scoliosis Outcomes Database Registry

The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. Study procedures include collecting data on clinical, radiographic, and patient-reported outcomes over a 25-year period. The investigator is Aaron J. Buckland, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Brooke O’Connell, MS, research coordinator, at 646-794-8643 or brooke.oconnell@nyulangone.org.

Sports Medicine Clinical Trials

Below is a list of our sports medicine clinical trials.

Agili-C Implant Performance Evaluation

The purpose of this study is to compare the efficacy and safety of the Agili-C implant with the surgical standard of care for the treatment of joint surface lesions of the knee. The investigators are Eric J. Strauss, MD; Laith M. Jazrawi, MD; and Robert J. Meislin, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by CartiHeal, Inc.

Diffusion Tensor MRI Versus Goutallier for Massive Cuff Tears

The purpose of this study is to assess the potential benefit of diffusion tensor MRI sequence for evaluation of patients with massive rotator cuff tears before and after surgery. We are comparing this imaging sequence with standard MRI sequencing and classification system for rotator cuff tears. The investigators are Soterios Gyftopoulos, MD, and Laith M. Jazrawi, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Samuel L. Baron, research fellow, at samuel.baron@nyulangone.org.

Effectiveness Trial for Evaluating IAHA for PFPS

The purpose of this study is to determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine whether this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis. After treatment, patients are followed for up to three months, using common pain and function subscales to assess improvements. The investigators are Dennis A. Cardone, DO, and Laith M. Jazrawi, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, which is now closed, was sponsored by Ferring Pharmaceuticals.

Efficacy of AposTherapy in Knee OA

The purpose of this study is to examine the efficacy of AposTherapy® at 6 and 12 months after treatment for knee osteoarthritis (OA). Our primary efficacy assessment is based on improvement in knee pain score and improvement in function in patients, as compared with a control group, after diagnosis of OA. The investigator is Dennis A. Cardone, DO.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, currently in a data analysis phase, is sponsored by Apos US Management, Inc.

A Post-Market, Single-Blind, Multicenter, Randomized, Controlled Trial of HYMOVIS Intra-Articular Injections in Active Subjects with Knee Osteoarthritis

The purpose of this trial is to compare responses to treatment with HYMOVIS® injections combined with a physical exercise program (PEP) with responses to PEP alone in subjects 21 to 55 years of age with patellofemoral osteoarthritis, tibiofemoral osteoarthritis, or both. The study allows subjects randomized to the PEP-alone study group to cross over to the HYMOVIS®-plus-PEP group if improvement has not been achieved by the three-month follow-up visit. The investigators are Eric J. Strauss, MD, and Laith M. Jazrawi, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial is sponsored by Fidia Pharma USA, Inc.

An Investigation of ReNu Knee Injection in Patients with Osteoarthritis

The purpose of this study is to evaluate the efficacy of the ReNu knee injection for the treatment of grade 2 or 3 osteoarthritis, based on the Kellgren-Lawrence grading system. Patients are randomized into one of three groups for injection into the affected knee: injection with ReNu; injection with hyaluronic acid, using common injection material; or injection with saline. After treatment, patients are followed for up to 12 months, using common pain and function subscales to assess improvements. The investigators are Eric J. Strauss, MD; Dennis A. Cardone, DO; Laith M. Jazrawi, MD; and Robert J. Meislin, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, which is now closed, was sponsored by NuTech Medical, Inc.

Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

The purpose of this study is to evaluate how intraoperative sensors may help surgeons achieve appropriate knee position and balance during knee replacement surgery (also called total knee arthroscopy, or TKA). We also collect information about the participants’ pain, function, and satisfaction with their knee replacements. The investigators are Ivan Madrid, MD; Patrick A. Meere, MD; and Peter S. Walker, PhD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, currently in long-term follow-up, is sponsored by OrthoSensor, Inc.

Prospective Efficacy Evaluation of Subchondroplasty for the Treatment of Defects Associated with Bone Marrow Lesions

The purpose of this study is to provide an estimate of the one- and two-year clinical success rates of the Subchondroplasty® procedure with minimum bias and sufficient statistical precision to permit meaningful comparison with commonly accepted one- and two-year clinical success rates for currently available treatments. The investigators are Thomas Youm, MD, and Laith M. Jazrawi, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. This trial, currently in long-term follow-up, is sponsored by Zimmer Biomet.

SCP Observational Study of the Knee

The purpose of this study is to understand postoperative outcomes in subjects choosing to have the Subchondroplasty® (SCP®) procedure. SCP® treats bone defects in knees associated with bone marrow lesions. Subjects complete questionnaires about their pain and function. The investigator is James Gurtowski, MD.

For more information about this trial, contact Ariel Aponte, ACRP-PM, CCRC, senior clinical research coordinator, at ariel.aponte@nyulangone.org. See full clinical trial information. This trial, currently in long-term follow-up, is sponsored by Zimmer Biomet.

Testosterone Levels in Anterior Cruciate Ligament Reconstruction

The purpose of this study is to evaluate whether anterior cruciate ligament (ACL) reconstruction surgery has an effect on testosterone levels and whether testosterone levels have an effect on ACL reconstruction outcomes by collecting clinical data and patient-reported outcomes over a one-year period. The investigators are Guillem Gonzalez-Lomas, MD; Laith M. Jazrawi, MD; Eric J. Strauss, MD; Michael J. Alaia, MD; and Kirk A. Campbell, MD.

For more information about participating in this trial, including additional eligibility criteria, contact Samuel L. Baron, research fellow, at samuel.baron@nyulangone.org, or Kamali Thompson, clinical research fellow, at kamali.thompson@nyulangone.org.