BBI Contributing Writer
SAN DIEGO, California More than 4 million people in the U.S. seek medical care each year for shoulder problems. Nearly 300,000 will undergo surgical repair of the rotator cuff. Although there are many reasons for shoulder pain, a common problem for those over 40 years of age is a rotator cuff tear. The rotator cuff is comprised of the muscles and tendons that surround the top of the humerus and hold it in the shoulder joint. A tear may result suddenly from a single traumatic event or develop gradually because of repetitive overhead activities.
During the annual meeting of the American Orthopaedic Society for Sports Medicine (AOSSM; Rosemont, Illinois) held here in July, one debate centered on how best to repair torn rotator cuffs. Is it better to use an arthroscopic approach or better to open the shoulder and accomplish the repair under direct vision? Robert Arciero, MD, of Farmington, Connecticut, spoke for the arthroscopic approach, and Edward Craig, MD, of New York, took the open surgery position. Arciero opined that the arthroscopic approach is superior in that it preserves the deltoid muscle, gets results just as good as an open procedure and allows treatment of associated pathology. "Even massive cuff repairs can be done arthroscopically," he said. Arthroscopic cuff repairs do require advanced arthroscopic skills, according to Arciero. Surgical time can be longer than the open, but the repair is equally strong and the results are equivalent.
"Preserving the deltoid muscle allows for quicker rehabilitation," Arciero said. "While even the 'mini-open' procedure where the incision is less than six inches splits the deltoid muscle and brings increased stiffness to the joint." The arthroscopic approach may provide a better range of motion and certainly causes less pain. Patients use fewer narcotics, and length of stay is shorter than with the open technique.
Taking the opposing view, Craig said, "The best way to fix the rotator cuff depends on the patient and our own skills. We have to evaluate how good we are at both the arthroscopic and open approaches and decide what is best." Using the "mini-open" technique, Craig gets 84% to 95% good and excellent results. Failures are rare. "The repair depends on the device or method used to repair the tear," he said. He questioned whether the arthroscopic devices such as tacks and anchors have the mechanical strength of a double row of sutures applied under direct vision. In Craig's opinion, the mini-open approach is best.
Julie Mary McBirnie, MD, of Edinburgh, Scotland, and Anthony Miniaci, MD, of Toronto, Ontario, presented their findings in a study using Suretac III Fixation Device and Rapid Delivery System from Smith & Nephew Endoscopy (Andover, Massachusetts) for cuff repairs. The pair reported satisfactory outcomes and no complications related to the Suretac III. The deltoid muscles were preserved in these patients and there was less soft tissue dissection. The surgeons were able to deal with other intra-articular pathologies. These teams found the tacks less demanding with a shorter learning curve than with other fixation devices like suture anchors. The Suretac was used for full thickness tears in 103 patients where the average tear was 2.5 cm. The tacks are made of polyglycolic acid polymer, which degrades to gel and is absorbed by hydrolysis in four to six weeks. The head of the Suretac is 8 mm in diameter and the shaft is 16 mm long by 3 mm in diameter. The teams used one Suretac for every 1 cm of torn rotator cuff.
Six-year study of ACI for the knee
Knee cartilage damage does not normally regenerate. In addition to causing pain and restricted mobility, chronic injuries to joint cartilage over time may lead to further deterioration of the joint service. More severe and chronic forms of knee cartilage damage can lead to greater deterioration of the joint and may eventually lead to one of the approximately 200,000 total knee replacements performed in the U.S. annually. Autologous chondrocyte implantation (ACI) uses a patient's own cartilage cells to repair traumatic damage to articular cartilage and thereby improve joint function and reduce pain. The procedure involves collecting and producing an ex vivo culture of articular cartilage cells. These are later implanted into the patient's cartilage defect, where they contribute to regeneration and repair of the articular surface. This technique is marketed as Carticel (autologous cultured chondrocytes) by Genzyme Biosurgery (Cambridge, Massachusetts).
Jon Browne, MD, of the University of Missouri-Kansas City School of Medicine (Kansas City, Missouri) and others reported on a six-year multi-center outcomes study. Sixty-two patients completed six-year evaluations, and 14 patients had incomplete follow-up. Mean age was 36 years. ACI patients continued to report statistically and clinically significant long-term improvements in symptoms and were able to return to a high level of physical function, including sports. Browne noted that these good results are very promising given the severity of illness of these patients at baseline. They had multiple previous or concurrent operations. Large/multiple defects were present, and 40% of the patients were worker's compensation patients.
Evolutionary tools for sports medicine
AOSSM exhibitors offered new minimally invasive devices for the arthroscopic approach to rotator cuff repair. In particular, the Opus Medical (San Juan Capistrano, California) instruments seem cleverly evolved from disposable suturing/stapling devices used in laparoscopy. Extracorporeal shockwave machines were shown for treatment of heel and elbow pain having evolved directly from similar equipment used by urologists for fragmentation of kidney stones.
Many arthroscopic surgeons believe the weakest link in arthroscopic rotator cuff repair is the knot tying. No two arthroscopic knots are tied exactly the same. As a result, arthroscopic cuff repairs are difficult to reproduce and leave a stack of bulky knots in the joint. The minimally invasive AutoCuff System from Opus Medical includes the company's core technologies the SmartStitch Suturing Device and the Magnum Knotless Fixation Implant. When used together, they eliminate the shortcomings found in many current shoulder repair devices. The suturing device eliminates knot tying by using a mechanized mattress stitch. The device places the stitch directly into the tissue. Once the stitch is placed in the cuff, the surgeon loads and deploys the Magnum Knotless Implant. An internal mechanism provides cinchable and reversible tension for good tissue-to-bone interface.
Urologic surgeons have been using extracorporeal shockwave lithotripsy for almost 20 years to treat kidney and ureteral stones. Similar new devices are being used by orthopedic surgeons and sports medicine specialists for the treatment of heel pain (plantar fasciitis) and tennis elbow. Available devices include the OssaTron from Healthtronics Surgical Services (Marietta, Georgia) and the Epos Ultra from Dornier MedTech (Kennesaw, Georgia). EMS Medical-America (Dallas, Texas) showed its Swiss DolorClast, which has been used in Europe for several years. The device is in clinical trials in the U.S. and not yet available for sale.
Application of extracorporeal shockwave treatment in orthopedics can involve the use of low, medium or high-energy systems also known as piezoelectric, electromagnetic or electrohydraulic respectively. The OssaTron device uses electrohydraulic or spark gap technology the same platform used for kidney stones. Treatments are accomplished in the operating room with the patient under light general anesthesia. The Epos Ultra uses an electromagnetic shock wave emitter. Dornier says there is no need to use the device in the operating room, as no anesthesia is required. The DolorClast uses a radial shockwave mechanism. The OssaTron costs about $250,000 and weighs 704 pounds; the Epos Ultra costs about $350,000 and weighs 270 pounds. No price is yet set for the DolorClast, but company reps estimated it will be a fraction of its competitors. It weighs just 66 pounds.