Amit Mor – What current rehabilitation methods have been doing is showing them how to stand in the clinic. We wanted to be able to simulate real life.

For two decades, Yael Duvdevany suffered terrible knee and joint problems. The retired nurse from Mount Sinai Hospital in New York was diagnosed with osteoarthritis, a chronic disease that causes the cushioning (cartilage) between the bone joints to wear away, leading to pain and stiffness. It can also cause new pieces of bone, called bone spurs, to grow around the joints.

“I had severe pain when walking long distances,” Duvdevany told ISRAEL21c from her Tel Aviv home where she moved upon retirement.

But over the last year, Duvdevany has experienced a physical rebirth and today can go for long walks and even two-hour workouts without feeling knee pain. She credits a unique walking system invented by two Israeli physicians specializing in orthopedic rehabilitation for her new condition.

The APOS system, developed by APOS Medical and Sports Technologies Ltd. of Herzliya, looks like a makeshift type of rollerskate – with two half-balls protruding from the shoe’s base. But it’s anything but a toy.

Developed over eight years by Drs. Amit Mor and Avi Elbaz (from the Assaf Harofe Medical Center in Tel Aviv), the APOS shoe has been clinically proven to both improve the patient’s gait and alleviate the pain in the knee and other leg joints.

“At Mount Sinai, I had access to many types of physical therapy. But this shoe does everything – it’s great,” said Duvdevany who was one of 61 patients who took part in trials of the APOS shoe held throughout Israel last year.

Currently, 21 million Americans have osteoarthritis (OA), and according to statistics, 50 percent of people aged over 50 in the Western world suffer from OA – and it gets worse as you get older. The consensus solution – painful and costly joint replacement operations, said Mor, speaking to ISRAEL21c from the company’s APOS clinic in Herzliya.

“Basically the way joint rehabilitation has been carried out over the last 50 years or so hasn’t change,” Mor explained. “The most important issue is functional rehabilitation – the simulation of life and environment. For example, what do you want an injured person to be able to return to do? To be able to go out and walk in the supermarket. But what current rehabilitation methods have been doing is showing them how to stand in the clinic. We wanted to be able to simulate real life.”

Mor explained that for the first few thousand years of man’s existence, there wasn’t a problem with neuro-muscular control – people walked in sand, mud, natural platforms that went up and down in natural inclines and declines, forcing people to use all their muscles equally.

“Nowadays, with Crocs, Nikes, and all the artificial flat surfaces made of parquet or carpet, everything is level, and every step we take is no different from the last thousand steps, or the next thousand steps. In addition, we all sit near a computer where we work in unnatural settings – the result is osteoarthritis, back pain,” said Mor.

“Our aim was to simulate the way mammals rehabilitated in nature and evolution but we wanted to KISS – keep it simple. We wanted to connect the hemispheres under the hind and fore foot,” he added, explaining that a hemisphere creates multi-directional instability and has been the general practice for decades in simulating instability for patients.

The result is the APOS footwear that involves the use of semispherical, individually calibrated bio-mechanical units that are placed on the soles of the shoes at the hindfoot and forefoot. These units can move medially, laterally, forward, and backward, and may be individually adjusted in order to balance loads.

The APOS individually calibrated shoes provide dynamic wedging, and can significantly reduce pain and improve function in patients with knee osteoarthritis. The footwear can enable patients to walk painlessly during real-life activity, thus reacquiring neuromuscular skills and balance.

“It’s the first and only rehabilitation device and treatment method that works through all the phases of the step cycle,” said Mor. “This is the reason we’ve named it APOS.”

Mor and Elbaz took their invention to Dr. Mati Nof, an orthopedic specialist at Assaf Harofe who is an expert in foot and ankle surgery as well as joint replacement.

“Amit and Avi came up with the concept that by giving people more instability when walking, it activates muscles and positions the leg in ways they weren’t being used,” Nof told ISRAEL21c. “With physiotherapy, you do the same thing – you activate those muscles, but then you go home and try the exercises, and it doesn’t work so well, or you don’t pay attention to do them right.”

Nof, who founded a company which was later sold to Johnson and Johnson, agreed to serve as an advisor for the fledgling company, because he was excited about the breakthrough he saw coming.

“For the first time, with the APOS system, the patient is forced to use the correct muscles without thinking about it,” he said. “And with the clinical trials, what they found is that after a while, it not only helps the way the patient walks, but it also reduces the pain.”

To examine the effectiveness of the APOS system in reducing pain and improving function, the researchers (headed by Prof. Nahum Halperin, head of the orthopedic division in Assaf-Harofe Medical Center, former head of the Israeli Orthopedic Society and one of Israel’s foremost joint surgeons) conducted a double-blind study of 61 knee OA patients.

The patients were randomized into active and placebo groups, and underwent eight weeks of treatment. Patients in the placebo group wore shoes that appeared identical to those worn by the treated group, but did not include the units on the soles.

The findings showed that 69% saw improved function, and 70% of the subjects saw a decrease in pain.

“For 70% of the subjects, the pain was diminished in such a way that they decided against having a joint replacement operation,” emphasized Nof. “More amazingly, after the shoe was removed, they continued to walk like they were walking with the shoe – they learned instinctively to walk the way they should walk so as not to cause more injury. I was astonished.”

Mor and Elbaz were overjoyed and vindicated by the trial results, and the resultant buzz that has followed.

“It was an unprecedented result – and since then we’ve presented the findings at the annual conference of OARSI – The Osteoarthritis Research Society International, as well as before the Academy of Orthopedic Surgeons,” he said.

The Apos System has been approved by both the FDA and the Israeli Ministry of Health, and it has two patents in the US – one for the device and the other for the treatment. According to Mor, over 3,500 people have been treated at the APOS clinic in Herzliya which opened last year.

“When a patient first comes in, we calibrate the platform, and customize it for each patient. When they start walking the pain goes away. It trains the muscles to regain control of the joints again. At the beginning, they use the device for 20-30 minutes a day. When they remove it, the pain is still there, but after two months, they’ve learned to regain control and the pain is lessened,” he said.

“The patient returns for a half dozen visits during the first six months to be recalibrated and checked. And then there are occasional return visits every few months for observation and “fine tuning.” We’ve seen patients who had difficulty walking 200 yards now walking three or four miles.”

“It was a little strange to be walking on balls at first,” admitted Duvdevany. “But once I got used to it, I started walking faster, and it made me feel more secure. Before, I felt that something was always about to happen to my knee.”

Health funds in Israel are now beginning a reimbursement policy for the device, according to Mor, who estimated that 15,000 Israelis would be using the system next year. APOS plans to open more clinics in Israel as well as their first education and treatment centers in the US and England. The treatment – including the platform, the treatment and return visits, costs around $3,000.

“We’re feeling a lot of enthusiasm and joy to see what we envisioned become bigger than we imagined,” said Mor.

Mor’s joy is nothing compared to the happiness felt by Duvdevany and the other patients who have learned to walk anew thanks to the APOS system.

“Now, I go to the gym for two hours and exercise and feel very little pain. I’ve kept using it steadily, even though I started over a year ago. I come back for checkups every three or four months and get the rubber balls replaced,” she laughed. “I wear them out from all that walking.”

(For more information, email amitm@apos.co.il)