New Shoulder Surgery Successfully Treats Serious Injuries

A surgeon at the Emory Sports Medicine Center has helped to pioneer a surgical option for people suffering from severe shoulder injuries.

Spero Karas, MD, Emory orthopaedic surgeon and team doctor for the Atlanta Falcons, has found safe and effective results using a procedure called the “Bridge Technique” for rotator cuff injuries. This procedure uses a skin graft that is surgically attached to both the deficient tendon and bone to ‘bridge’ the defect.

“We have a number of treatments available to fix most rotator cuff injuries, but there are times when the tendon defect is so severe that those options are inadequate,” says Karas, who is also an associate professor of orthopaedics at Emory University School of Medicine.

For individuals with severe injuries that were untreatable in the past, this is a procedure that now offers a potential alternative.

"When the rotator cuff is repaired using this technique, it reestablishes normal function of the rotator cuff," Karas explains. "This results in eliminating pain, improving function and potentially slowing the progression of arthritis."

Not only does this procedure offer help for patients who may never have been able to completely recover from a serious injury, but Karas says it also may give the patient the ability to return to normal activity.

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FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs

The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.

To support the effort to help these patients, the agency also is launching a new Web site where patients and their health care professionals can learn about options for investigational drugs. In general, these options include being treated with a drug that has been approved by FDA, being given an investigational drug as part of a clinical trial, or obtaining access to an investigational drug outside of a clinical trial.

The new rule, “Expanded Access to Investigational Drugs for Treatment Use,” makes investigational drugs more widely available to patients by clarifying procedures and standards. The other rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the specific circumstances and the types of costs for which a manufacturer can charge patients for an investigational drug when used as part of a clinical trial or when used outside the scope of a clinical trial.

“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”

Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials.

The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.

“The final rules balance access to promising new therapies against the need to protect patient safety and seek to ensure that expanded access does not discourage participation in clinical trials or otherwise interfere with the drug development process,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Clinical trials are the most important part of the drug development process in determining whether new drugs are safe and effective, and how to best use them.”

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Emerging Techniques Put a New Twist on Ankle Repair

/PRNewswire / -- People with ankle injuries who do not respond successfully to initial treatment may have a second chance at recovery, thanks to two new procedures developed to restore the injured area, according to a study published in the July 2009 issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS).

The study reviews emerging techniques that have proven successful in treating injuries to the talus, the small bone, which is located between the heel bone and the lower bones of the leg. The talus helps form the ankle joint.

Although most injuries to the talus can be successfully treated using traditional "first-line" therapies involving removal of dead tissue (called "debridement") and drilling, about one-fifth to one-quarter of people with ankle injuries need additional "second-line" restorative treatment to heal successfully, said lead author Matthew Mitchell, M.D., an orthopaedic surgeon in private practice in Casper, Wyoming.

The two new techniques rely on cells grown in a lab, and eliminate the need for ostetomy (cutting the bone of the tibia) in some cases, he said.

-- Autologous chondorcyte implantation, or ACI, involves removing
cartilage cells from the knee or the ankle and growing them in a lab.
Once grown, the cartilage is transplanted to the talus. ACI usually
involves an ostetomy in order to implant the cells.

-- In matrix-induced autologous chondrocyte implantation, or MACI, cells
are grown on a special backing material, or "matrix," and then
transplanted to the talus. In the authors' experience, an osteotomy
is not necessary to implant the cells.


Of these two techniques, the newer MACI technique may offer the most benefits to the patient, according to Dr. Mitchell.

"Both ACI and MACI show a lot of promise, but I think the advantage of MACI is that an osteotomy is not necessary in order to successfully implant the matrix," he said. "You only need to make an incision to place the graft, which decreases the morbidity of the procedure quite a bit."

"In my experience so far with this emerging technique in Australia, the results have been as good as, or better than, other restorative techniques," he added. MACI is currently considered investigational by the FDA in the United States.

Traditional restorative techniques involve removing a cartilage donor plug from the knee and implanting it over the ankle injury, or "lesion." This requires an operation on the knee and cutting the bone (osteotomy) of the tibia to accommodate the graft. As a result, these traditional techniques involve potential problems, including:

-- pain in the donor knee
-- tissue damage in the donor knee
-- tissue damage in the ankle as a result of osteotomy

"In most individuals, results are favorable with reparative techniques, such as debridement and drilling," said Dr. Mitchell. "The lesions that are problematic and which don't respond well to reparative treatments are lesions that are larger, and those which are fairly deep, as well as lesions which have a cyst-like structure. Whether or not an ankle "lesion" requires additional treatment after an initial reparative procedure often depends upon several factors, including: size, depth and structure of the legion.

"Once you've performed a reparative technique and the patient still doesn't heal properly, then we would move on to a second-line restorative treatment," he said.

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