Trial aims to cushion rotator cuff blow

Balloon offers a new treatment for major tears
March 20th, 2016

Madeline Vogt doesn’t appear to have much in common with baseball players. The 69-year-old had a career in the banking industry and now enjoys retirement in Arvada with husband Herman. But Vogt shares one thing with guys who throw the horsehide around: She has a rotator cuff injury.

Jonathan Bravman, MD, an orthopedic surgeon at UCH, examines images of a patient’s shoulder before an outpatient procedure Feb. 29.

Like dozens of ballplayers, mostly pitchers, Vogt suffered a “full thickness tear” – 5 centimeters or more – in the muscles and tendons collectively called the rotator cuff. They connect the bone at the top of the arm (the humerus) to the shoulder blade (the scapula). These bones, with the glenoid cavity, respectively form the ball-and-socket shoulder joint. When the rotator cuff is intact, it helps the joint to move freely. A rotator cuff tear destabilizes the joint and can lead to friction between the two bones.

For a pitcher, it’s a painful and sometimes career-ending injury. For a non-athlete like Vogt, a serious rotator cuff tear puts a big crimp in everyday activities. Vogt traces her injury to a day the hatchback of her car fell and hit her right arm while she unloaded groceries. She tried to rehabilitate with physical therapy, but the pain grew progressively worse, making tasks like vacuuming, picking up dishes, folding towels, and even combing her hair wince-inducing.

“It limits my movement, and when it flares up, the pain is very sharp,” Vogt said.

Unless he intends to hang up the cleats, a rotator cuff injury for a ballplayer means surgery to reattach torn tendons and muscle to the bone, and Vogt could have chosen the same route. Instead, she enrolled in a new FDA study and had the possibility of receiving a device designed to reduce the pain by cushioning the space between the humerus and the scapula.

Filling a gap

Bravman Shoulder Scope
The InSpace procedure began with Bravman using a scope to examine damage to a patient’s rotator cuff.

The procedure, the first of its kind in the United States west of the Mississippi, occurred Feb. 29 at University of Colorado Hospital as part of a randomized clinical trial of the InSpace device, a biodegradable polymer balloon delivered by a cylinder-shaped tube in a minimally invasive outpatient procedure. Jonathan Bravman, MD, an orthopedic surgeon at UCH and director of both Sports Medicine Research and the Shoulder Center for University of Colorado Sports Medicine, led the procedure and is the principal investigator for the trial, which targets patients with full thickness rotator cuff tears.

The balloon nestles between the head of the humerus and the acromion, which forms the top of the shoulder blade, and acts as a spacer between the bones. The rotator cuff tear doesn’t heal, Bravman said, but the balloon helps to center the head of the humerus to the scapula. The repositioning stabilizes the joint and reduces stress while the patient rehabilitates. The balloon gradually degrades over a six- to 12-month period.

The Feb. 29 procedure in an Anschutz Outpatient Pavilion OR began with Bravman inserting a scope fitted with a camera in Vogt’s upper arm while she was under general anesthesia. Bravman steered the scope into and around the rotator cuff and the surrounding tissue. He watched the images projected on flat-screen TVs above the table, periodically conferring with Itay Barnea, CEO of OrthoSpace, the Israeli manufacturer of InSpace. In perhaps 20 minutes, Bravman and Barnea agreed that Vogt’s rotator cuff had sustained extensive damage.

Vogt was one of several patients included in the study that day and since the patients are “blinded” to their treatment as part of the study, she and the others do not know if they received either the new device or the current standard of care – an arthroscopic debridement of frayed tissue with a partial rotator cuff repair, if the remaining tissue will allow it.

Bravman InSpace
The thin tube in Bravman’s hand is the InSpace delivery device.

However, in at least one of the procedures that day, with Barnea watching and advising, Bravman inserted the InSpace delivery system, fitted at the tip with a crimped balloon, in the patient’s upper arm and guided it to the space below the acromion. When he and Barnea agreed that it was positioned correctly, Bravman inflated the balloon with saline, sealed it, and then retracted the delivery device. The InSpace portion of the procedure was over in a matter of minutes.
As for Vogt, Bravman noted that her condition falls in a kind of orthopedic “gray area.” The joint damage was not yet serious enough to indicate replacing the shoulder, which is one of the only solutions for an irreparable rotator cuff tear with shoulder pain. But rotator cuff repair, while potentially possible in the outpatient setting, would have been difficult because the tear was so extensive.

“The muscles of the rotator cuff had atrophied to fat,” Bravman added. “That portends a poor prognosis in regards to seeing the tissue actually heal after surgery.”

The InSpace procedure, he said, offers patients like Vogt “a middle ground between reverse total shoulder replacement and partial rotator cuff repair or simple arthroscopic debridement. That’s the whole crux of what we are doing.”

Tried and true – elsewhere

Bravman InSpace Insertion
Bravman positions the device and prepares to inflate the balloon in the space below the patient’s shoulder blade.

The clinical trial will test the safety and efficacy of the InSpace device. Bravman said he plans to randomize up to 20 patients – the estimated total for all participating sites is a little more than 180 – with some undergoing the conventional repair procedure and others receiving the InSpace.

The device has been used to treat more than 5,000 patients in Europe since its approval in 2010.The stringency of the U.S. device approval process has delayed adoption in the United States, Bravman said, but its success in Europe is a plus for potential approval.

“We’re not experimenting with a new device,” he said. He noted that European orthopedic surgeons now frequently deliver the InSpace while patients are under local anesthetic in a procedure that takes only about 12 minutes.
Four days after the procedure, Vogt does not know which procedure Bravman performed, but she is hopeful for a good recovery. “I’m doing great,” she said in a phone interview.

She will need eight to 12 weeks of physical therapy, which she began two days after the procedure with a provider close to her home. Her arm was in a sling and she was still taking pain pills, but the prospect of relief lay ahead. She will continue to see Bravman at regular intervals.

“I’m not moving much yet,” Vogt said, “but the pain has already lessened from what it was before.”

About the author

Tyler Smith is a freelance writer based in metro Denver.