MCHAMP
MChamp
MCHAMP

Current MCHAMP Clinical Trials

AMNIOFIX

A phase 2b prospective, double-blinded, randomized controlled trial of the micronized DHACM injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee

Study Title:
A phase 2b prospective, double-blinded, randomized controlled trial of the micronized DHACM injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee

Disease:
Knee Osteoarthritis (OA)

Study PI:
Tariq Awan, DO

Study Coordinator:
Jordyn Sessel, jsessel@med.umich.edu

Study Overview:
Osteoarthritis of the knee is an almost universal occurrence in older patients, where it represents the biggest cause of disability and reduction of activity in patients over the age of 50. Treatment options include: lifestyle modification such as low-impact exercise and weight reduction; oral medications such as NSAIDS and acetaminophen, dietary supplements; injectable medications such as corticosteroid; other injections such as hyaluronic acid (HA) and platelet rich plasma (PRP); physical therapy; and surgery such as knee arthroscopy and knee replacement.

We are testing AmnioFix Injectable, a human tissue allograft made from part of human placenta, the amniotic membrane. We want to see if it will reduce knee pain, minimize stiffness, or improve function. Once assigned to a group, you will be seen by a member of the study staff. You will return to the clinic 6 times after your treatment visit, at 30 days, 60 days, 90 days, 180 days, 270 days and 365 days. Each visit will last about 30 minutes. At each visit, your study doctor will examine your knee, talk to you about your knee pain, check to be sure you are not having problems with your study treatment, ask about other medicines you are taking, and ask you to fill out the same questionnaires as you did at your first visit.

Link to study/sponsor website:
https://mimedx.com/amniofix/

ANCHOR – FAI

Study Title:
Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery

Disease:
Hip Abnormality

Study PI:
Asheesh Bedi, MD

Study Coordinator:
Bethany Ruffino, bruffino@med.umich.edu

Detailed Description:
The group is based out of and coordinated by Washington University in St. Louis, MO, and currently includes 15 surgeons at nine institutions. The investigators collect data on hip preservation procedures, including outcome measures of hip function, hip pain, quality of life, overall health, high-level activity, and economic value. This collected data can then be used by all contributing surgeons for research purposes, facilitating high-volume, multi-center research.

The purpose of the study is to follow patients who had surgery for FAI, to see how well they heal, and compare differences in treatments. It is hoped this will help us to best understand how to treat FAI. During this study we will collect information routinely obtained as part of your standard of care visits both pre-and-postoperatively and at annual time points. This information includes: clinical exam findings, patient reported outcomes measures, radiographic imaging, surgical findings, intra-operative images and/or videos, and photographs. Intra-operative images and/or videos are not identifiable because they are taken inside the hip joint or right outside the hip joint. No tattoos or scars can be seen because skin around the joint is covered.

Link to study/sponsor website:
https://www.anchorhipsurgeons.com/research-adolescent-adult-hip-disorders.html

ANCHOR – REPOSITORY 2

Study Title:
Joint Preservation (JP) Repository 2 – ANCHOR

Disease:
Hip Abnormality

Study PI:
Asheesh Bedi, MD

Study Coordinator:
Bethany Ruffino, bruffino@med.umich.edu

Detailed Description:
The group is based out of and coordinated by Washington University in St. Louis, MO, and currently includes 15 surgeons at nine institutions. The investigators collect data on hip preservation procedures, including outcome measures of hip function, hip pain, quality of life, overall health, high-level activity, and economic value. This collected data can then be used by all contributing surgeons for research purposes, facilitating high-volume, multi-center research.

This research study is a database of information (research repository). The purpose of this research database is to collect data from patients treated with surgery for hip disorders. All collected data will be analyzed to help identify and improve the surgical care of future patients with hip problems.

If you are a patient that is scheduled to have hip surgery with Dr. Bedi, and are over the age of 9, you are eligible to participate in this study. You may not participate if you are pregnant or nursing.

Link to study/sponsor website:
https://www.anchorhipsurgeons.com/research-adolescent-adult-hip-disorders.html

ARC

Study Title:
Operative versus Non-Operative Treatment for Atraumatic Rotator Cuff (ARC) Tears: A Multicenter Randomized Controlled Pragmatic Trial

Disease:
Rotator Cuff Tears

Study PI:
Bruce Miller, MD

Study Coordinator:
Bethany Ruffino, bruffino@med.umich.edu

Detailed Description:
Rotator cuff tears are one of the most common causes of shoulder pain in adults in the United States, accounting for 10.7 million outpatient doctor visits in 2013. Specifically, it is estimated that 65-70% of adults with shoulder pain have an underlying rotator cuff disorder. Rotator cuff injuries are common due to their degenerative nature, meaning that they occur slowly over time as a person ages, often without a distinct injury. These kinds of tears are classified as atraumatic.

The two standard treatments for atraumatic rotator cuff tears are non-operative (physical therapy alone) and operative (surgery followed by physical therapy). The percentage of rotator cuff patients treated with surgery rose from 33.8% to 40.4% from 2005 to 2012, showing an increasing tendency to treat with surgery. It is not clear, however, if this trend has resulted in more successful outcomes for patients. The purpose of the ARC Trial is to help answer this question. We are also studying whether size of tear and age influence which treatment works best. This trial is different from previous observational studies because patients are randomly assigned to a treatment group, which will allow us to better measure the differences between these two treatments without any biases. We believe this study will help patients and providers to make better and more informed decisions in the future.

Link to study/sponsor website:
https://shoulderstudy.org/studies/arc-trial/

INGENERON

Study Title:
A Prospective, Double Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection into Chronic Partial-Thickness Rotator Cuff Tears

Disease:
Rotator Cuff

Study PI:
Tariq Awan, DO

Study Coordinator:
Jordyn Sessel, jsessel@med.umich.edu

Detailed Description:
The purpose of this clinical trial is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after they receive a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to when they receive of a single corticosteroid injection. There are cells that exist within your fat cells that will be concentrated and injected and we think that this might help with healing.

A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the startup of a similar study with a larger number of participants. A total of 246 patients will be studied from between 10-20 sites in the United States.164 patients will be enrolled in the investigational treatment group and 82 patients will be enrolled in the control treatment group. Up to 20 subjects at the University of Michigan will take part.

Link to study/sponsor website:
http://ingeneron.com/

MIACLR

Study Title:
The Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

Disease:
Anterior Cruciate Ligament (ACL)

Study PI:
Riann Palmieri-Smith

Study Coordinator:
Bethany Ruffino, bruffino@med.umich.edu

Detailed Description:
Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may help prevent the post-traumatic knee osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction. However, a fundamental gap exists in our understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. Our pilot work shows that when patients return to activity, quadriceps strength is ~70% of the uninjured side, which is far below the recommended 90%. Further, our data suggest that embedding high-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise into standard of care ACL rehabilitation leads to higher quadriceps strength when compared with standard of care alone. However, the true efficacy of these interventions is unknown, as we currently lack controlled trials with adequate sample sizes. The absence of this information serves as the driving force and focus of the proposed trial. This study is innovative because it employs interventions that directly target the primary mechanisms that result in strength loss following ACLR and will also evaluate whether improving muscle strength can minimize early changes in cartilage health, which may be indicative of future osteoarthritis. The proposed research is significant as it will identify evidence-based treatment approaches that can successfully counteract the muscle weakness that plagues ACLR patients for years after injury and contributes to the onset of post-traumatic osteoarthritis.

Link to study/sponsor website:
https://www.kines.umich.edu/research/orb

NOVOCART

Study Title:
A Phase 3 Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART® 3D,Compared to Microfracture in the Treatment of Articular Cartilage Defects

Disease:
Multi-Ligament Knee

Study PI:
John Grant, MD

Study Coordinator:
Jordyn Sessel, jsessel@med.umich.edu

Detailed Description:
The purpose of this research study is to assess the pain, stiffness and physical function of your knee. You will receive one of two possible surgical procedures. One surgical procedure, which is the investigational procedure under study, utilizes the Novocart® 3D autologous cartilage implant system. The other possible procedure is called Microfracture and is one of the current standard of care options to treat your condition. Both surgical procedures will be followed by pain and knee function assessments and a course of physical rehabilitation.

Novocart® 3D is the cellular implant system that is being investigated in this clinical study. “Investigational” means that this study product has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authorities in the United States. The investigational treatment (Novocart® 3D) in this study has been used in Europe since 2003 to treat patients with damaged knee cartilage.

Link to study/sponsor website:
https://www.aesculapbiologics.com/en/patients.html?utm_source=km&utm_medium=ppc&utm_campaign=patient

ORTHOFIX

Study Title:
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of Pulsed Electromagnetic Field (PEMF) therapy with the use of a special device as an adjunctive treatment to surgical repair of full thickness rotator cuff tears

Disease:
Rotator Cuff Tears

Study PI:
James Carpenter, MD

Study Coordinator:
Bethany Ruffino, bruffino@med.umich.edu

Detailed Description:
The purpose of this research study is to understand if PEMF (Pulsed electromagnetic field) therapy with the RCStim device (shoulder brace being studied) will help reduce tendon re-tear rate, decrease user pain, and increase the range of motion and strength of the shoulder following surgical repair of a full thickness rotator cuff tear. Some study patients will receive an active PEMF device and some study subjects will receive a placebo (control) or inactive device for the entire 6-month period. Because this study is a randomized, double-blind study, neither the patient nor the study doctor knows which device (active or placebo) the patient is getting. The assignment of the device is random, like the flip of a coin, with 2 out of 3 people receiving an active PEMF device as receiving a placebo (control) device (that is, 1 out of 3 people would get a placebo (control) device). The RCStim device is not approved for use as a medical device by the Food and Drug Administration (FDA). Therefore, its use is considered to be experimental.

Link to study/sponsor website:
https://clinicaltrials.gov/ct2/show/NCT03339492?term=Orthofix&draw=2&rank=2

STABLE

Study Title:
Shoulder Instability Trial – STABLE

Disease:
Shoulder Instability

Study PI:
Asheesh Bedi, MD

Study Coordinator:
Bethany Ruffino, bruffino@med.umich.edu

Detailed Description:
The shoulder is the most commonly dislocated joint in the body with a global incidence that ranges from 15.3 to 24.8 per 100 000 people. Anterior dislocations, the most common type of shoulder dislocation, are often complicated by subsequent instability, and recurrent dislocation, with reported rates as high as 42% and primarily affecting young males. Shoulder instability commonly results in pain and negatively impacts quality of life. Shoulder pathology is the third most common cause of musculoskeletal pain and in the United States estimated direct costs for the treatment of shoulder pathology accounts for over $7 billion USD annually. A number of long-term studies have demonstrated an association between the recurrent instability episodes and the risk of degenerative arthritis and more than 50% of patients with shoulder instability will go on to require surgical intervention.

The goal of this study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic capsuloligamentous repair vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and outcomes over a 24-month period. This trial led by McMaster University.

STAR

Study Title:
Surgical Timing and Rehabilitation (STaR) for Multiple Ligament Knee Injuries (MLKIs): A Multicenter Integrated Clinical Trial

Disease:
Multiple Ligament Knee

Study PI:
John Grant, MD

Study Coordinator:
Jordyn Sessel, jsessel@med.umich.edu

Detailed Description:
Combat and sports injuries as well as automobile accidents can result in complex knee injuries involving tears of two or more major ligaments. These are referred to as multiple ligament knee injuries (or knee dislocations). Other structures like nerves, blood vessels, tendons and bones may also be injured at the same time. Due to their severity, knee dislocations are difficult to treat and problems after surgery, such as poor healing, stiffness or looseness of the knee, persistent pain, and early arthritis, can be quite common.

Experts agree that surgery is necessary after a knee dislocation, but they do not agree on when to perform surgery or when rehabilitation after surgery should be started. Early surgery for knee dislocations may result in better outcomes, but may also be associated with increased joint stiffness. However, delayed surgery may be associated with the knee being too loose.

The best evidence for when to start rehabilitation is based on treatment of anterior cruciate ligament (ACL) injuries in sports, where early post-op rehabilitation is the standard. However, unlike ACL surgery which typically replaces the ACL with a tendon graft, surgeons frequently sew torn ligaments back together after a knee dislocation. Therefore, rehabilitation typically involves protection of the knee by keeping weight off the leg and not allowing the knee to move for 6 weeks, which may delay return to activity.

This study is being conducted to determine when is the best time to do surgery is and when to start rehabilitation after surgery for the treatment of a multiple ligament knee injury.

Link to study/sponsor website:

https://clinicaltrials.gov/ct2/show/NCT03543098

SVF

Disease:
Rotator Cuff

Study Title:
SVF Cells for Nonoperative Treatment of Small Rotator Cuff Tears

Study PI:
Tariq Awan, DO and Michael T Freehill, MD

Study Coordinator:
Jordyn Sessel, jsessel@med.umich.edu

Detailed Description:
Partial and small rotator cuff tendon tears are a big challenge in shoulder care. They are often not operated on because research has not shown any benefit of surgery over non-surgery in these types of tears. The most common way to treat these tears is through physical therapy or cortisone injections. However, the relief provided through these treatments is short-lived. Recent studies have shown a high occurrence of the tear size worsening over time. This occurs because the non-surgical options can treat the pain and symptoms, but do not heal the actual tear.

Another non-surgical option for treating partial and small tears is through adipose-derived stem cells. Found in the fat in our bodies, adipose-derived cells have shown promise in repairing tissue and may provide assistance to the non-surgical treatment of small rotator cuff tears. We are studying a part of these adipose-derived cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. These cells are removed from your body using liposuction. They are cleaned, processed and reinjected to your shoulder. This is important because they have the ability to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used SVF cells to help the non-operative treatment of small tears. Our goal is to determine the effectiveness of SVF-cell injection to improve the non-surgical treatment of small rotator cuff tears. This study is a randomize double blind trial. This means that you have a 50:50 chance of getting your cells injected back to your shoulder or you will receive a cortisone injection. You or you treating doctor and study team will not know which injection that you received.