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Active Implants’ VENUS Clinical Trial for Persistent Knee Pain Now Underway in Memphis

Active Implants’ VENUS Clinical Trial for Persistent Knee Pain Now Underway in Memphis

OrthoMemphis Only Site in the South – and One of 10 Sites Nationwide – Enrolling Patients
in New Study of Investigational NUsurface® Meniscus Replacement

 

MEMPHIS, Tennessee – February 9, 2016 – Active Implants, a Memphis-based company that develops orthopedic implant solutions, today announced that the company’s VENUS (Verification of the Effectiveness of the NUsurface® System) trial is now underway at OrthoMemphis. OrthoMemphis is the only center in the South – and just one of 10 sites nationwide – participating in the VENUS clinical trial to evaluate the Active Implants’ NUsurface (pronounced “new surface”) investigational meniscus implant for the treatment of persistent knee pain caused by injured or deteriorating meniscus cartilage.

 

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal.  Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery. NUsurface is being evaluated as a new treatment option to fill the gap between minimally invasive meniscus repair and total knee replacement.

 

“There aren’t many options for patients who experience persistent knee pain following meniscus surgery,” said Dr. Randall Holcomb, orthopedic surgeon at OrthoMemphis. “Damage to the meniscus can lead to arthritis and the need for knee replacement surgery. We hope this study finds that the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery.”

 

The VENUS study will enroll approximately 130 patients at orthopedic centers in the U.S., Europe and Israel. Participants who meet study requirements and agree to enter the trial are randomized to receive either the NUsurface device or non-surgical treatment, which is the current standard of care for patients with persistent knee pain following meniscus surgery.

 

“We are excited to have OrthoMemphis – a leader in orthopedic care throughout the Southern states that is conveniently located in our back yard – participating in the VENUS study,” said Henry Klyce, chief executive officer of Active Implants, which established its U.S. headquarters in Memphis in 2004. “There is a large, unmet need in the orthopedic market for a new treatment option for the many patients who continue to suffer from knee pain even after undergoing meniscus surgery.”

 

To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the study, visit or call (844) 680-8951 or visit www.meniscus-trial.com.

 

 

About the NUsurface® Meniscus Implant

In the U.S., the NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery.  NUsurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint.  It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation.  After surgery, patients undergo a six-week rehabilitation program. NUsurface has been used clinically in Europe since 2008 and Israel since 2012.

 

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle.   Active Implants is privately held with headquarters in Memphis, Tennessee.  European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

 

About OrthoMemphis

OrthoMemphis’ team of 19 doctors provides surgical and non-surgical treatment in general orthopedic and subspecialty areas of sports medicine, spine, hand, foot & ankle, hip & knee, total joint replacement, treatments of bone and soft tumors of the extremities (benign and malignant) in children and adults, and workers’ compensation injuries. For more information, go to http://www.orthomemphis.com/.

 

CAUTION Investigational device. Limited by United States law to investigational use.

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Back on the Saddle | Health + Fitness Magazine

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While cycling is not America’s favorite pastime, it has its ups and downs, and Jimmy Reed, 57, co-owner of Marx-Bensdorf Realtors, experiences the good, the bad, and the broken.

Reed has been riding since 1983, and was sold on the sport after placing fifth in his first race.

“It sucked me in to it,” Reed said. “I remember how painful and fun it was at the same time. It’s a crazy addiction.”

From then on Reed has competed 12 to 15 times a year, finishing without a scratch in most races.

“Some race courses are truly dangerous, but I got banged up on a fairly unchallenging turn in the road,” Reed said.

In many cycling accidents, when one falls, the rest come tumbling after, which is what happened to Reed.

“With whatever activity you happen to love, you have to get back on the horse,” Reed said.

But Reed wasn’t thrown off of a horse in some lush field. He was bumped off his bike during a road race in East Tennessee. The crash left him with road burns, five broken ribs, and a shattered right collarbone.

“The drive home was a little uncomfortable,” Reed said.

Like any injury needing assistance, Reed met with doctors, but not until he drove more than 200 miles to Memphis to see the doctors at OrthoMemphis.

Twenty plus years of riding will take its toll on any body. As an endurance athlete, Reed has go-to surgeons.

“Randy Holcomb at OrthoMemphis was shaking his head when looking at the x-ray,” Reed said.

Prior to this accident, Holcomb operated on Reed multiple times. However, with Holcomb unavailable for a quick surgery, Reed was referred to and operated on by doctors David Brown and Kenneth Weiss, also of OrthoMemphis.

Reed was familiar with Weiss and Brown’s work through his wife, Janice, who also lives an active lifestyle that requires medical attention from time to time.

It’s been nearly six months since Reed’s late-July accident, and he’s almost fully recovered.

“The recovery time was slower than past experiences given all the damage,” Reed said. “But I am very happy to be back riding.”

The doctors told Reed that his surgery was as successful as they hoped it would be. After a shattered collarbone, he can expect to regain full range of motion within a few months, progress which he also contributes to Casey Malone in the rehab department of OrthoMemphis.

Through hard times and broken bones, Reed manages to hop back on the saddle and do what he loves.

“Folks that are truly passionate about their activity are blessed,” Reed said. “The friendships you make with like-minded people are really a blessing.”

Mike Neel OrthoMemphis | Click Magazine

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As Memphis’ foremost orthopaedic oncologist, Dr. Mike Neel has pioneered changes in a myriad of procedures that were once guaranteed to end in amputation. Neel specializes in limb salvation and the diagnosis and treatment of various kinds of bone cancer. Through his treatment and research, he has saved countless lives and limbs in the battle against osteosarcoma and other forms of malignant bone growth.

Neel’s role as one of less than 150 orthopaedic oncologists in the country attracts patients in need of highly specialized care. With the aid of a team of nurse practitioners, he has divided his time as an orthopaedic specialist between OrthoMemphis and St. Jude Children’s Research Hospital for 19 years. “It’s about a 50/50 split,” Neel says. “It’s a challenge, but I have a lot of people to help me bridge the two worlds.”

Neel’s work alongside 16 other specialists at the OrthoMemphis clinic in East Memphis consists of surgical procedures to remove malignant bone tumors, while avoiding amputation in the process. Limb-sparing procedures at this location are often performed on adults seeking total hip and knee replacements, as well as those with oncological issues such as metastatic tumors associated with other forms of cancer that may have spread to the skeletal system. “With adults, the orthopaedic problems are usually secondary to their primary cancer,” he says. “We see a lot of patients with other forms of cancer, where it has spread to the bone.”

While much of Neel’s work at OrthoMemphis focuses on adult reconstructive surgery, his time at St. Jude is spent developing new and innovative surgical techniques and methods of treatment for younger patients. At St Jude, Neel deals with the removal of malignant tumors, as well as the application of various prostheses and management of complications associated with leukemia and subsequent chemotherapy.

In adolescents, the problem usually begins within the musculoskeletal system in the form of malignant tumors caused by osteosarcoma, the most frequently contracted form of bone cancer in the United States. Neel’s research also deals with Ewing’s Sarcoma, another form of bone cancer that primarily affects the arms and legs. Both are especially prevalent in younger cancer patients.

Aside from the research and obvious age discrepancy in patients, Neel’s job at St. Jude carries a few added bonuses. “I tend to get more hugs from the kids, I think,” he says.

Neel’s other duties include treating bone lesions and making strides to shape larger invasive surgeries into smaller more manageable procedures with less lingering trauma. However, simple pain management is often key for the day-to-day rigors of treatment. “Sometimes, you’re doing nothing more than making the patient comfortable,” he says.

In 2005, Neel performed a first-of-its-kind surgery involving the implementation of the bone transport rod, a high-tech tool that eschews the traditional bone-graft method in lieu of a state-of-the-art metal rod. This procedure is unique in that it allows for a patient’s prosthesis to grow along with them by moving the tumor along the bone and adjusting by centimeters as it scales to a patient’s exact height. “We’re able to move the defect down the bone – like a napkin ring – and new bone is filled in behind it,” Neel says.

Patients return periodically for a non-invasive lengthening procedure. This provides newly formed native bone that adapts to a patient much easier and presents a safer, less invasive alternative to traditional bone grafts. The recepient, a young osteosarcoma sufferer, eventually made a complete recovery. “Right now, he’s back to lifting weights, jumping rope, and doing everything he wants as an 18 year-old kid,” Neel says.

Stories like this have become the hallmarks of Neel’s career. A native Memphian and father of two, the University of Tennessee graduate is familar with the characteristics that make a superior surgeon. “The most important quality is somewhere between compassion and energy – nobody goes into this business without a healthy does of both,” says Neel.

Pain management with a focus on comfort seems to be the central theme of OrthoMemphis, which provides a variety of services in addition to Neel’s oncological offerings, including treatment of the spine, hand, foot, and athletic injuries. “We’re big enough to provide a lot of services, but small enough to have a lot of professional interaction among the different surgeons,” Neel says.

 

Local Athlete Receives Bone Transplant

Paragould Daily Press by Katelyn Brown

A year ago 13-year-old Jacob Whitby-Lange would have appeared to be just another seventh-grader on his basketball team running, jumping, and scoring but, by his eigth grade year at Paragould Junior High things began to change.

Jacob like most kids his age began hitting a growth spurt and complained of minor pain along the way.

His mother Lorie just assumed that it was due to growing pains but as time progressed so did the pain.

She began noticing that Jacob was almost in tears every car ride home from practicing basketball.

“Jacob just isn’t one to complain that often,” says Lorie

Between the car rides and watching him play Lorie knew that there was just more to it than growing pains.

“By the time we would get home his leg would have had time to cool off. It would lock up and take Jacob a few tries to be able to just walk again,” says Lorie.

Lorie took Jacob to Dr. Ron Schecter an Orthopedic Surgeon at NEA Baptist, who after seeing Jacob felt certain a bone in his left leg was dead and advised Lori to take him to Memphis to see Orthopedic Dr. Michael Neel.

Once in Memphis several MRIs and X-rays were taken confirming that the bone in Jacob’s leg was in fact decaying.

As Lorie took a closer look at the x-rays, she compared the readings to resembling that of mashed potatoes.

She explains that the reasoning behind Jacob’s condition remains a mystery because he never sustained any major or minor injuries as a child.

The only explanation Lori can give is that he grew so quickly while playing a sport such as basketball that blood was unable to properly flow to his leg. “It just seems like the perfect storm,” says Whitby.

Dr. Neel’s partner Dr. Kenneth Weiss has performed several surgeries at St. Jude’s Hospital for Children who because of having cancer have experienced similar situations with their bones dying. He agreed to take on Jacob’s case.

In May 2013, Jacob was enlisted on a donor waiting list to receive the use of a cadaver bone as it became available.

Dr. Weiss informed the Whitby-Lange family that Jacob’s wait for a bone may not be as long as other children because of his height and the ability to use an adult size bone instead of a child sized bone.

“We were just at the mercy of their call and fortunately it was not long,” says Lorie.

During class on Aug. 20, Jacob’s mom sent him a text message that read: “We got a bone.”

“I was excited and thought alright we are really doing this,” Jacob said.

On Aug. 26, Jacob underwent a surgical procedure called Osteo Articular Allograft, which allowed Dr. Weiss to go in and carve out all the dead bone and tissue areas and hammer in a cadaver bone in its place.

It was a 4 cm long area located under his femur bone, which is the bone that starts at the hip and ends at the knee.

Currently, the doctors are waiting for Jacob’s bones to calcify over the new tissues. Until then Jacob will continue to place absolutely no weight on his left leg to ensure proper healing can take place.

“It’s not fun, but I am getting use to it,” says Jacob, who is not allowing this to keep him down.

Since the procedure Jacob has been on crutches, but continues to cheer on his teammates during their ball practices as he continues to work on his shots from home.

Lori said that she often finds Jacob in their driveway sitting in a lawn chair shooting hoops.

“It has really helped me develop more strength in my arms, but I’m afraid once I get back out there I may shoot too hard,” says Jacob.

Basketball isn’t the only sport that has been made more difficult for Jacob.

Jacob is an avid bow hunter and having this procedure has limited his chances of killing a deer this season.

He must sit in a ground blind because he cannot climb up into a deer stand with his crutches.

“Sitting on a ground blind puts me at eye level with deer, so they can easily spot me and it puts me at a real disadvantage,” says Jacob.

Today, after eight weeks of having no weight on his left leg, Jacob will return to Memphis for Dr. Weiss to check the progress made since his surgery.

“I just want to be normal again and my overall goal is to be back on the court playing at the end of this season,” says Jacob.