A New Solution For The Arthritic Ankle
Arthritis of the ankle can be a painful and disabling condition. Clinicians can effectively treat mild or moderate arthritis with conservative therapies and joint preserving surgical procedures.1-5 Advanced cases that do not respond to more conservative measures require aggressive surgery. Traditional procedures for severe ankle arthritis pain include ankle arthrodesis and arthroplasty with implant. These are lengthy, usually invasive procedures that can successfully treat severe ankle arthritis but they also have some serious surgical risks. Researchers have reported rates of deep infection and non-union with ankle arthrodesis that range between 5 and 11 percent.6,7 Many patients and surgeons are reluctant to opt for this procedure since eliminating movement at the ankle can produce an aberrant gait and limit the patient’s ability to return to normal activity. Ankle joint arthroplasty with total joint replacement has its own drawbacks. Most importantly, ankle implants are not yet a realistic option for many patients. There are specific surgical indications for this procedure and not all patients with severe ankle arthritis are candidates for an ankle implant.8 Additionally, there are few surgeons in the United States who have ankle implant training and who regularly perform the surgery. Although ankle replacement may sound like a desirable option, the literature regarding ankle implants suggests that improvements in implant design are needed.9 Accordingly, we sought to evaluate two minimally invasive techniques, ankle arthrodiastasis and joint fluid replacement therapy. These procedures are not joint destructive and provide the podiatric surgeon with an option for patients who are in serious pain but are also reluctant to undergo a fusion procedure. Surgeons have used these procedures separately to treat arthritis of many joints in the lower extremity. While these techniques are relatively new, the early research has been promising.10-13
What The Literature Reveals About Arthrodiastasis And Joint Fluid Replacement
The term “arthrodiastasis” comes from the Greek word “arthros” for joint, and “diastis,” which means a separation or gap. Although the concept was discussed as early as 1978, the use of joint distraction as a means of treating cartilaginous defects became more common in Europe during the late ‘80s and early ‘90s. The term arthrodiastasis was coined around 1993 by Canadell, Gonzalez, Barrios and Amillo. They used the term to describe a procedure, which involved the stretching of hip joints in adolescent patients with Legg-Calves-Perthes disease to relieve intraarticular pressure.10 In 1995, van Valburg, et. al., studied arthrodiastasis on a series of 11 patients with post-traumatic arthritis of the ankle. They applied distraction with an Ilizarov frame for three months as a means of preventing or delaying the need for arthrodesis. Patients reported pain relief for an average of two years after the removal of the frame.11 Van Valburg, et. al., reported a follow up study in 1999. They found that using an Ilizarov frame to distract the arthritic ankle allowed patients to ambulate during treatment and produced “significant improvement” in two-thirds of patients.14 Many other authors have subsequently reported on the successful use of arthrodiastasis to restore function of arthritic joints.15-19 Recently, Ploegmakers, et. al., published a seven-year follow-up study that evaluated ankle joint distraction via the Ilizarov method for the treatment of osteoarthritis. They found significant clinical benefit in 73 percent of patients and failures in 27 percent of the patients. While they concluded that arthrodiastasis can be effective for severe ankle arthritis, the authors emphasized the need for further research in order to predict which patients will do well with this approach.20 Joint fluid replacement therapy involves injecting the joint with a synovial fluid-like solution containing hyaluronan. Hyaluronan is secreted by cells in the cartilage of joints and is one of the major molecular components of joint fluid. It gives the joint fluid its viscous quality. The high viscosity of synovial fluid allows for the cartilage surfaces of joints to glide upon each other in a smooth fashion. Researchers have shown that intraarticular hyaluronan injections are a safe, effective treatment for osteoarthritis of the knee.21-29 The use of these injections for the treatment of ankle arthritis is not FDA approved and, to the best of our knowledge, has not been reported in the literature. With these points in mind, we proceeded to conduct a multicenter study that examines the combined use of arthrodiastasis and joint fluid replacement therapy for treating advanced ankle arthritis.
Key Insights Into A Multicenter Study
Between May of 2001 and July of 2003, we treated a total of 65 ankles in 63 patients for various forms of degenerative joint disease of the ankle. The patients included in this study were those with moderate to severe arthritis of the ankle. This was defined as a painful joint with limited range of motion, arthritic changes on standard radiographs, persistent pain despite previous treatment and symptoms of at least one year in duration. The average patient age was 42.5 years with patients ranging in age between 28 and 62 years with a standard deviation of 7.51 years. Forty-one patients were male and 22 patients were female. Forty-four patients (68 percent) were diagnosed with osteoarthritis, 13 patients (20 percent) with posttraumatic arthritis, five patients (8 percent) with Charcot arthropathy and three patients (5 percent) with adult residual clubfoot. Utilizing small, tensioned wires (1.8 mm), the surgeons applied a full-ring, small wire external fixator to the foot and leg with standard Ilizarov technique. The construct consisted of two rings and a foot plate connected with threaded rods. The surgeons distracted the ankle joint 5 to 10 mm by adjusting the nuts on the threaded rods between the footplate and distal ring. We verified the distraction length under C-Arm imaging. We proceeded to evaluate vascular supply and small vessel integrity via palpation of pedal pulses, capillary refill time and observation. Patients received the first joint fluid replacement therapy intraoperatively with a 2.5 mL injection of Supartz (hyaluronan, 25 mg/2.5 mL). We administered subsequent injections once a week for a total of five injections. Surgeons encouraged patients to begin full weightbearing on the first postoperative day as tolerated. We removed the external fixator after five weeks. The surgeons participating in the study performed postoperative examinations on the third and 14th postoperative day, and at subsequent one-month intervals for one year. At these visits, we asked patients to evaluate and rate their pain according to the Wong-Baker FACES pain rating scale.30,31
Analyzing The Results And Some Key Study Caveats
There was a marked reduction in overall pain at each postoperative visit for the majority of the patients. Two patients had increased pain at the 12-month visit and went on to an arthrodesis of the ankle joint. The most common complication we saw was superficial infection of the pin site. All 11 patients (17 percent) with this complication were treated with oral antibiotics and proper pin care. There were no deep infections. Four patients (6 percent) had ligamentous laxity and instability. We successfully managed these patients with physical therapy and functional bracing. Six patients (9 percent) continued to have edema to their operated ankle at the 12-month follow-up visit. Two patients (3 percent) developed a superficial necrosis along the anterior medial ankle. In both of these cases, the necrosis resolved with local wound care. There were no deep infections in this study. We did not see any allergic reactions to the hyaluronan injection therapy. The results of this particular study suggest that ankle arthrodiastasis with joint fluid replacement therapy may be a useful adjunct in managing progressive pain and debilitation from ankle joint osteoarthritis. These procedures gave the majority of patients the pain relief needed to continue normal activity and avoid ankle fusion. We are unable to determine how long the positive trend in pain relief will continue for these patients. The relative contribution each therapy made to this pain relief is also unknown. This study lacks control over the many variables involved in this procedure. We were more focused on providing optimal healing conditions for the patients rather than limiting the potential for healing with a variable controlled study. It is not clear as to which component of this procedure is most beneficial. Future study designs may possibly include comparing each variable individually for the treatment of ankle joint osteoarthritis. Other possibilities include a double-blind, placebo-controlled study comparing saline injection versus hyaluronan injections. Data for a one-year postoperative follow-up period is reported here. Long-term results and follow up studies are necessary to better evaluate this treatment for ankle arthritis.
A Closer Look At Supporting Theories
The goals of this study did not include an investigation into the methods by which these procedures relieved patients’ pain. However, previous research on cartilage regeneration and joint distraction have produced some theories. Gavril Ilizarov, the founder of the circular frame external fixator, developed the theory of tension stress, which states that controlled, mechanically applied tension and stress produces reliable regeneration of bone and soft tissue. This relates to cartilage regeneration in that applying tension along soft tissues during distraction stimulates microangiogenesis. This mild hypervascularity plays a key role in the reparative processes by enhancing nutrient synthesis and distribution to the articular cartilage.32 Another theory proposes that the combination of ankle distraction with ambulation produces ideal fluctuations in joint pressure similar to that of a continuous passive range of motion (CPM). Many scientific investigations on a variety of experimental models of the knee joint have shown that continuous passive range of motion stimulates pluripotential mesenchymal cells to differentiate into articular cartilage.33-35 In these studies, healing and regeneration of articular cartilage occurred after researchers applied CPM nonstop, day and night for a minimum of one week. This postoperative protocol is not practical for many patients who place great importance on returning to daily activity. Patients treated with the Ilizarov method of circular ring fixation are not only allowed to ambulate but encouraged to do so. The combination of weightbearing on the externally fixated limb with unloading and protecting the ankle from pathological forces creates the proposed healing environment. The biomechanical properties of the small wire, Ilizarov frame allow a small amount of axial motion with weightbearing but only minimal shearing and torsional forces.36 The slight flexibility of the wires creates a trampoline effect that produces intermittent fluid flow with loading and unloading. Ambulation on a distracted ankle that is relieved of normal mechanical stress creates small fluctuations in the joint fluid pressure that have been shown to significantly improve patients’ pain and functional ability in clinical trials.14 Studies evaluating the actual effects of joint distraction on cartilage have found that low levels of intermittent fluid pressure have beneficial effects on joint tissue in osteoarthritis.37,38 Van Valburg, et. al., performed an animal study to examine the effects of distraction on articular cartilage at a cellular level. They found that these changes in hydrostatic pressure stimulate cartilage matrix synthesis and decrease production of catabolic cytokines.37 They concluded that joint distraction could accordingly be a useful treatment for osteoarthritis. The exact mechanism by which hyaluronan produces its therapeutic effects is also unknown. Current research suggests that it reduces nerve impulses and nerve sensitivity associated with the pain of osteoarthritis. Hyaluronic acid (hyaluronan) is a glycosaminoglycan that has protective effects on cartilage. Researchers believe that exogenous hyaluronic acid enhances chondrocyte hyaluronic acid production, increases proteoglycan synthesis and reduces the production and activity of proinflammatory mediators and matrix metalloproteinases.39
Arthrodiastasis with hyaluronan joint fluid replacement therapy can reduce pain and preserve joint function in patients who suffer from moderate to severe ankle arthritis. One can use these minimally invasive procedures to treat ankle arthritis and delay, if not avoid altogether, the need for ankle fusion. While the arthrodiastasis procedure requires appropriate training and experience, applying the small wire, circular ring fixator becomes less complicated and expeditious with time. Further research is needed to determine the duration of pain relief that surgeons can achieve with these procedures. However, in our experience, arthrodiastasis with joint fluid replacement therapy is a useful intervention for painful and disabling ankle arthritis, and can help relieve pain and improve the patient’s quality of life. Dr. Vito is the Director of the Atlanta Leg Deformity Correction Center in Macon, Ga. He is a Fellow of the American College of Foot and Ankle Surgeons, and is a faculty member of the Podiatry Institute. Dr. Pacheco is a fourth-year resident at Mercy Hospital in Miami. Dr. Southerland is a Biomechanics Professor at the Barry University School of Graduate Medical Sciences in Miami Shore, Fla. Dr. Rodriguez is in private practice at the Chicago Foot and Ankle Deformity Correction Center in Chicago. Dr. Thompson is in private practice at the South Florida Institute of Sports Medicine in Weston, Fla.
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