Study Examines Combination Of Procedures For Hallux Rigidus

Can a combination of two procedures yield positive results for patients with hallux rigidus? A recent study, presented as an abstract at the annual meeting of the American College of Foot and Ankle Surgeons (ACFAS), notes increased function and decreased pain in patients who underwent a combination of a hemi-implant arthroplasty with a decompressional osteotomy.
As part of the study, 11 patients with hallux rigidus underwent the combination of surgical procedures. Patients had either grade III or IV hallux rigidus, less than 20 degrees of first metatarsophalangeal joint (MPJ) dorsiflexion, and a first and second intermetatarsal angle of less than 14 degrees. Of the eight patients available for follow-up, six patients received the Waterman-Green osteotomy and K2 hemi-implant (KMI), one received the Waterman-Green osteotomy with the Great Toe Hemi Implant (Biopro), and one underwent the Austin-Youngswick osteotomy and received a K2 hemi-implant.
Patients who underwent the combination procedure experienced a significant decrease in pain and increase in function, according to the study. Eighty-seven percent of the patients (or seven out of the eight patients) rated their surgical results as good, very good or excellent. One patient reported a fair result.
Robby Amiot, DPM, a co-author of the study, says a 13-month follow-up revealed that the patients’ average American Orthopedic Foot and Ankle Society (AOFAS) Hallux MPJ/IPJ score increased by 31.7 points. He adds that the total range of first MPJ motion increased by an average of 20.1 degrees after the surgery and notes that patients’ average dorsiflexion increased 19.2 degrees after the surgery.

Dr. Amiot says the combination treatment has promising results and believes its long-term results will prove to be better than performing only a hemi-implant arthroplasty or a first MPJ fusion. Dr. Amiot is currently working on a long-term prospective study to examine the effects of the therapy.
“We feel maintaining motion of the first MPJ is extremely important for a patient to have a normal gait pattern,” says Dr. Amiot. “It is our belief that a decompressional osteotomy of the first metatarsal will not only plantarflex the metatarsal head but will also decompress the first MPJ.”
He notes the decompression will permit a greater post-op range of motion as opposed to performing only a hemi-implant arthroplasty.
Dr. Amiot compares the decompressional osteotomy to distraction arthrodiastasis of the first MPJ, saying each procedure permits greater joint space, easier range of motion and results in less pain.

What About Potential Complications?
As Dr. Amiot points out, a few patients experienced “minor” post-op complications. However, with the exception of one patient, Dr. Amiot says the complications did not affect the surgical outcome. He says the rate of complications in the study is equivalent to the complication rates reported in other hallux limitus/rigidus studies.
Among the complications was a delayed union in a patient, who was noncompliant and a smoker, and wound up achieving clinical and radiographic union after conservative measures. Another patient with a stress fracture healed with conservative treatment, notes Dr. Amiot.
One patient experienced deep vein thrombosis but later rated his result as excellent and wants to have the procedure performed on his contralateral foot, according to Dr. Amiot.

New Studies Tout Efficacy Of Duloxetine
By Brian McCurdy, Senior Editor

In recent years, a number of new medications have emerged to help control the pain associated with diabetic peripheral neuropathy. How effective is duloxetine HCl (Cymbalta, Eli Lilly) in treating neuropathy? Three new studies, presented in abstract form at the annual meeting of the American Academy of Pain Management, give duloxetine high marks for its pain relief properties.
As part of the three 12-week double-blind, placebo-controlled studies, researchers randomized a total of 1,139 patients who either took duloxetine or a placebo. Patients took duloxetine in doses of 20 mg qd, 60 mg qd or 60 mg bid. Using the Brief Pain Inventory, Short Form 36 and European Quality of Life Instrument 5D measurements, researchers assessed the functional outcomes as reported by patients.
The Brief Pain Inventory measurement showed duloxetine was superior to placebo when it came to general activity, walking ability, normal work and sleep, according to the study. The study notes the Short Form 36 measurement found duloxetine significantly superior to the placebo in the categories of general health, pain, vitality and physical functioning. Finally, researchers say the European Quality of Life scale showed duloxetine as “significantly better” than placebo.
“As an effective selective serotonin and norepinephrine reuptake inhibitor (SSNRI), duloxetine has the ability to address pain at its origin and clearly has helped many of my patients who have not responded to other forms of therapy,” notes Barry Rosenblum, DPM, an Assistant Clinical Professor of Surgery at Harvard Medical School.
Like any other drug or therapy used for diabetic neuropathic pain, some patients may respond and some may not, according to Dr. Rosenblum, who serves on the manufacturer’s advisory panel for the drug. However, he notes that one advantage to the drug is its FDA approval for painful diabetic peripheral neuropathy, the first drug to gain such approval.
On the downside, Dr. Rosenblum says cost is an issue, particularly if a third party payor does not pay for the new medication. He has encountered nausea as a side effect in patients but notes it resolves in a few days.
What about using duloxetine to treat depression? Although the drug is indicated to treat the depression that is often a side effect of diabetic neuropathy, Dr. Rosenblum says he has not used duloxetine for that purpose. However, as he notes, “that is not to say that patients with neuropathic pain may not have a dual mechanism of action and find benefit.”

Can 3D Technology Facilitate Customized Bone Grafts?
By Brian McCurdy, Senior Editor

When searching for bone graft options, podiatric surgeons may want to consider a new technology that permits three-dimensional fabrication of grafts. Authors of a new study say the technology gives DPMs the ability to customize grafts for patients.
In the study, which was recently presented as an abstract at the aforementioned ACFAS conference, researchers tracked the use of the 3D bone grafts in 36 patients over two years. The cases included 16 hindfoot or ankle fusions, six Lapidus fusions, three first MPJ fusions, four opening osteotomies, six calcaneus backfills and one secondary fill for bone loss due to a crush injury. The grafts were the cross-shaped TheriLok™, the wedge-shaped TheriWedge™ and the rectangular bar TheriLink™ (Therics). All were designed with a defined internal structure that encouraged ingrowth of bone and controlled resorption of the graft, according to the study. Researchers say surgeons wicked all the grafts with the patient’s blood or marrow.

In three months, each patient attained bony union with structural support, according to the study. Researchers also note that resorption occurred gradually and the grafts incorporated well.
“As a surgeon, the ability to make preoperative assessments and have a wedge, block or dowel made to your specific indications is quite a luxury,” comments study co-author Luis Leal, DPM.
Tailoring grafts to one’s specifications cuts out the guesswork and decreases time in the operating room, according to Dr. Leal, who practices at the Reconstructive Foot and Ankle Center at Palisades in Edgewater, N.J. As he notes, another advantage is how the granules of the grafts interlock so they will stay where the surgeon places them.

Alleviating Patient Concerns About Bone Grafts
Dr. Leal says emphasizing the potential benefits of this technology may help remedy patient concerns about bone grafts.
“Patients show great concern when they are informed that a bone graft is needed or may be needed to correct their condition,” says Dr. Leal. “They are well aware of the illegal harvesting of bone that has been in the news of late and are aware that this applies to all bone products, be it allograft or demineralized bone matrix (DBM).”
Dr. Leal says the Therics grafts mimic bone as if they were the patient’s own. If he anticipates the need for bone, Dr. Leal will use the patient’s own bone marrow to bolster the beta tricalcium graft. He says this provides patients with “the next best thing to their own bone” and avoids the morbidity associated with the harvest site. In intraoperative situations in which he does not anticipate grafting, Dr. Leal will mix the graft with the patient’s own blood.
During healing, the Therics grafts can act as a scaffold and do not resorb too quickly. Dr. Leal says this is an important consideration as too rapid resorption can lead to a poorly evolved bone. In addition, he says the graft does not stay in the body indefinitely and if something leaks from the graft site, it will not produce heterotopic bone.

In Brief

The American Medical Association has released two new Current Procedural Terminology (CPT) Codes for the application of Oasis products (Healthpoint). In addition, the Centers for Medicare and Medicaid Services has introduced a new HCPCS Level II code for Oasis products, according to Healthpoint.
CPT Code 15430 pertains to the use of an acellular xenograft for the first 100 cm2 or less, or 1 percent of the body area of infants and children. CPT Code 15431 is for the use of the acellular xenograft for each additional 100 cm2, or each additional 1 percent of body area of infants and children. Healthpoint notes that one should list the 15431 code separately in addition to the code for the primary procedure.
HCPCS Level II J7341 pertains to the use of a “dermal (substitute) tissue of non-human origin, with or without other bioengineered or processed elements, with metabolically active elements per cm2.”
The Oasis Wound Matrix is indicated for the management of partial and full-thickness wounds such as venous stasis ulcers and diabetic foot ulcers, according to Healthpoint.