Recommendations of the OARSI FDA Osteoarthritis Devices Working Group.

Osteoarthritis (OA) is the most common type of arthritis and a major cause of chronic musculoskeletal pain and functional disability. While both pharmacologic and non-pharmacologic modalities are recommended in the management of OA, when patients with hip or knee OA do not obtain adequate pain relief and/or functional improvement, joint replacement surgery or other surgical interventions should be considered. Total joint arthroplasties are reliable and cost-effective treatments for patients with significant OA of the hip and knee. Evidence from cohort and observational studies has confirmed substantial improvements in pain relief with cumulative revision rates at 10 years following total hip (THA) and total knee arthroplasties (TKA) at 7% and 10%, respectively. Joint replacements have been used in most every synovial joint, although results for joints other than hip and knee replacement have not been as successful. The evolution of new device designs and surgical techniques highlights the need to better understand the risk to benefit ratio for different joint replacements and to identify the appropriate methodology for evaluating the efficacy and optimal outcomes of these new devices, designed to treat OA joints.

The use of gravity or manual-stress radiographs in the assessment of supination-external rotation fractures of the ankle.

Supination-external rotation (SER) fractures of the ankle may present with a medial ligamentous injury that is not apparent on the initial radiographs. A cadaver gravity-stress view has been described, but the manual-stress view is considered to be the examination of choice for the diagnosis of medial injuries. We prospectively compared the efficacy of these two examinations. We undertook both examinations in 29 patients with SER fractures. Of these, 16 (55%) were stress-positive, i.e. and had widening of the medial clear space of > 4 mm with a mean medial clear space of 6.09 mm (4.4 to 8.1) on gravity-stress and 5.81 mm (4.0 to 8.2) on manual-stress examination, and 13 patients (45%) were stress-negative with a mean medial clear space of 3.91 mm (3.3 to 5.1) and 3.61 mm (2.6 to 4.5) on examination of gravity- and manual-stress respectively. The mean absolute visual analgoue scale score for discomfort in the examination of gravity stress was 3.45 (1 to 6) and in the manual-stress procedure 6.14 (3 to 10). We have shown that examination of gravity-stress is as reliable and perceived as more comfortable than that of manual stress. We recommend using it as the initial diagnostic screening examination for the detection of occult medial ligamentous injuries in SER fractures of the ankle.

Transarticular stabilization for malunited fracture of the distal tibia in diabetics with loss of protective sensation.

Five diabetic patients who require insulin developed symptomatic malunited stress fracture of the distal tibia and fibula. All were treated with intramedullary fixation crossing the ankle joint. All progressed to stable union without evidence of infection. Two patients treated with antegrade intramedullary nailing required nail exchange for subsidence at the fracture site. One patient sustained a fracture at the proximal tip of a short retrograde nail, requiring replacement with a longer nail. Transarticular intramedullary fixation is an effective method of achieving stabilization for malunited fracture of the distal tibia in individuals with diabetes who are insensate. Due to the risk of fracture at the proximal tip of a standard short intramedullary nail, it is recommended to use a nail that extends to the proximal tibial metaphysis.

Development of a nurse-provided health system strategy for diabetic foot care.

A nurse-provided university health system diabetic foot screening/education/treatment program evaluated 403 patients in the initial 12 months of development. All patients were provided individualized foot-specific patient education, varying in intensity with the magnitude of their risk status. One hundred and forty-five (36%) were categorized as being at risk for the development of a diabetic foot ulcer. Improper footwear capable of producing foot ulceration was recorded in 268 (66.5%) of the enrollees. Seven patients with previously undiagnosed Charcot foot disorder were identified. Eighty-three of the enrollees were seen at least once in follow-up. Sixty-one (73%) used improper footwear at the initial evaluation, which was decreased to 36 (43%) at the first follow-up visit. Nurse-provided foot-specific diabetic screening and education, combined with protective footwear, has been shown to be a cost- and resource-effective method of decreasing the rate of diabetic foot ulcers, and the risk for eventual lower extremity amputation.

Pitfalls in the treatment of fractures of the ankle and talus.

Displaced fractures of the ankle are a common component of current orthopaedic practice, whereas displaced fractures of the talus are unusual. Ankle fractures generally are produced by indirectly applied, relatively low energy forces, whereas talus fractures are created by higher energy axial loading. Despite these inherent differences, the end result of either injury can be avascular necrosis, posttraumatic arthritis, or soft tissue loss. Complications and poor results can arise from the inherent characteristics of the injury, from failure to accomplish appropriate treatment objectives, from overzealous treatment goals, or from overlooking subtle clinical or radiographic signs. The goal of the current study is to provide a method of evaluating the characteristics of these injuries to optimize functional outcomes and avoid morbidity.

Pedorthic management of the diabetic foot.

Foot ulceration in diabetic patients is a resource-consuming, disabling morbidity that often is the first step in the downward spiral to lower extremity amputation. The best treatment is prevention. Prevention of foot ulcers requires a coordinated program of foot-specific patient education, prophylactic skin and nail care, and protective footwear. The goal of prescription footwear is to keep individuals ambulatory, while protecting them from ulcer formation. The complexity of pedorthic prescription increases with decreasing protective sensation and increasing structural deformity of the foot and ankle. Prescription footwear accommodates deformity, while decreasing pressure and shear forces applied to skin overlying bone prominences.

Healing of partial flap necrosis in ankle disarticulation amputation by débridement and continued weight-bearing.

Five patients with partial tissue loss of the weight-bearing surface of the heel pad following ankle disarticulation were treated with residual-limb debridement and continued end-weight-bearing using a total-contact cast. The patients, ranging in age from 53 to 76 years, had insulin-requiring diabetes and insensate heel pads and were low-demand, limited-activity, community walkers before amputation surgery. Each underwent amputation surgery as a consequence of peripheral vascular disease. All patients progressed to complete wound healing over 3 to 6 months and were able to return to their previous ambulatory level using a prosthesis. At a minimum 2-year follow-up, no patient experienced further residual-limb complications. Partial loss of the weight-bearing heel pad in ankle disarticulation amputation does not preclude successful return to independent ambulation using a standard ankle disarticulation prosthesis. Weight-bearing ambulation need not be avoided during healing.

Peripheral neuropathy in the hands of diabetic patients with lower extremity amputations.

One hundred unilateral ambulatory lower extremity amputees underwent sensibility testing of their remaining foot and right hands to determine if the magnitude of peripheral neuropathy present in the feet of patients with diabetes was of greater magnitude than that in their hands. Testing was performed with a series of Semmes-Weinstein monofilaments. Ninety-one of the subjects were male, and 9 were female. Sixty-five were diabetic, 40 required insulin. The magnitude of peripheral neuropathy was compared between the hands and feet of patients with and without diabetes, and between insulin-dependent and non-insulin-dependent diabetics. There was a slight trend to a more severe degree of insensitivity in the feet as compared with the hands in each of the individual groups. There was no statistically significant difference when comparing hand and foot sensibility in any of the comparison groupings. The quantitative amount of peripheral neuropathy appears to affect the hands and feet of diabetics in a similar "stocking-glove" fashion. The results of this screening gives further support to the concept of prophylactic foot care programs in diabetics with peripheral neuropathy to decrease the risk for the development of foot ulcers, which are often the precursor of eventual lower extremity amputation.

Health related quality of life in patients with dysvascular transtibial amputation.

Sixty adults with transtibial amputations completed a validated outcomes instrument assessing their prosthesis related quality of life. All had their amputations because of peripheral vascular disease or nonsalvageable diabetic foot infection. Of the patients, 46 were male and 14 were female. Forty-four had diabetes. All of the subjects used a prosthesis for a minimum of 6 months. The Prosthetic Evaluation Questionnaire measured prosthesis function (usefulness, residual limb health, and appearance), mobility (ambulation and transfers), psychosocial response (perceived responses, frustration, and social burden), well-being, and satisfaction. Scoring was accomplished using a linear analog scale, with poor responses rated as 0 and excellent responses rated as 100. Mobility scores were the lowest (ambulation, 55.3; transfer, 64.6). Functional scores were slightly better (usefulness, 65.7; residual limb health, 79.7; and appearance, 73.3). Psychosocial response scored best (perceived responses, 86.6; frustration, 69.1; and social burden, 66.4). The overall well-being scale graded at 67.0, and overall satisfaction scored at 65.2. Although experts in rehabilitation would expect function and mobility scores to be highest and psychosocial scores to be lowest, this population actually perceived the reverse to be true. These data provide realistic expectations for patients faced with transtibial amputation and a benchmark to measure newer treatment modalities or technical innovations.

Current practice patterns in the treatment of Charcot foot.

Treatment of Charcot foot osteoarthropathy has emerged as a major component of the American Orthopaedic Foot and Ankle Society (AOFAS) Diabetes 2000 Initiative. A two-part survey described treatment patterns and current footwear use of patients with Charcot osteoarthropathy of the foot and ankle. In the first part, 94 consecutive patients with a history of Charcot foot and ankle presenting for care were questioned on their foot-specific treatment and current footwear use. A history of diabetic foot ulcer was given by 39 (41%) patients, and an infection had been present in a foot of 20 (21%) patients. The initial treatment of the Charcot foot and ankle had been a total contact cast in 46 (49%) patients, and a pre-fabricated walking boot in 19 (20%). Charcot related surgery had consisted of 76 procedures in 46 (49%) patients. Sixty-three (67%) patients were currently using accommodative footwear (depth-inlay shoes in 46 [49%], custom shoes in 10 [11%], and CROW in 7 [7%] patients), and 72 (77%) were currently using custom accommodative foot orthoses. The second part of this study consisted of a questionnaire completed by 37 orthopaedic surgeons (members of AOFAS) interested in forming a Charcot Study Group. They treated an average of 11.8 patients having Charcot foot or ankle per month. Thirty (81%) used the Semmes-Weinstein 5.07 monofilament as a screening tool for peripheral neuropathy. For treatment of Eichenholtz Stage I, 29 (78%) used a total contact cast and 15 (41%) allowed weightbearing; for Stage II, 30 (81%) physicians used a total contact cast and 18 (49%) allowed weightbearing. Although the literature contains uniform recommendations for immobilization and non-weightbearing as treatment for the initial phases of Charcot arthropathy, the results of this benchmarking study reveal that currenl treatment is varied.

North American experience with knee disarticulation with use of a posterior myofasciocutaneous flap. Healing rate and functional results in seventy-seven patients.

BACKGROUND: A method for closure of a knee disarticulation wound with use of the posterior calf skin and gastrocnemius muscle bellies as an integral flap, without destruction of the perforating vessels, was described by Klaes and Eigler in 1985. The purposes of the present study were to report our experience with use of this technique in a prospective series of knee disarticulations and to determine the healing rate and the functional result after use of the flap. METHODS: Eighty knee disarticulations, performed with use of the flap described by Klaes and Eigler, in seventy-seven patients were evaluated in a prospective manner. The patients ranged in age from nineteen to ninety-two years (mean, sixty-four years). Thirty-one patients had diabetes mellitus with peripheral vascular disease, and twenty-nine had peripheral vascular disease alone as the primary cause of gangrene. Fourteen patients had a traumatic injury, two had a sarcoma, and one had Ollier disease. RESULTS: Five patients died in the early postoperative period, leaving seventy-five stumps available for evaluation. A total of sixty-seven stumps (89 percent) healed; sixty-three (84 percent) of them healed primarily. Major wound dehiscence occurred in seven stumps (9 percent), requiring revision to the transfemoral level. Six of those patients had a serum albumin level of less than thirty millimoles per liter. Twenty-two (81 percent) of the twenty-seven patients who could walk before surgery were able to walk with a prosthesis after it. CONCLUSIONS: This simple technique offers reliable healing of knee disarticulation wounds in properly selected patients with a variety of conditions. It also provides comfortable end-bearing for prosthesis wearers because the distal flap is thick and mobile.

Intraoperative lower extremity compartment pressures in lithotomy-positioned patients.

PURPOSE: Measurement of anterior leg compartment pressures in eight patients (16 limbs) who were positioned in the lithotomy position for prolonged periods of time while undergoing colorectal intra-abdominal surgery. METHODS: Anterior leg compartment pressures were measured in eight patients (16 limbs) by using a slit catheter, whereas subjects were positioned in the lithotomy position for prolonged periods of time while undergoing colorectal intra-abdominal surgery. RESULTS: Compartment pressures had minor elevations after initial lithotomy positioning, and gradually increased over time. Levels elevated to 30 mmHg at an average of five (range, 3.5 to 6) hours. The maximum recorded leg compartment pressure was 70 mmHg. The addition of Trendelenburg positioning was noted to consistently increase compartment pressures. All pressures returned to less than 10 mmHg shortly after removing the limb from the stirrups and placing the limb supine. No patients developed clinical evidence of compartment syndrome. CONCLUSIONS: Leg anterior compartment pressures rise when limbs are placed in the lithotomy position for prolonged periods of time. The rise in pressure is increased with the addition of Trendelenburg positioning. Anterior compartment pressures reached a threshold of 30 mmHg at an average of five hours. The results of this study suggest that lithotomy positioning of the lower extremities has the potential to initiate leg compartment syndrome when the period of positioning approaches five hours. Removing the limbs from the stirrups and placing them in the supine position allows the pressure in the compartments to return to normal.

Charcot's foot.

Charcot's foot used to be considered an unusual complication of diabetic peripheral neuropathy. With the current appreciation that approximately 25% of adult diabetics have an appreciable peripheral neuropathy, it is understandable that Charcot's neuro-osteoarthropathy has become recognized as a major problem for clinicians caring for diabetics. Differentiation from acute diabetic foot infection is the first challenge. Once Charcot's foot is identified, treatment generally involves immobilization during the acute inflammatory stage. When deformity develops, the orthopedic foot and ankle surgeon must decide whether accommodative care with a combination of inlay depth shoes, accommodative foot orthoses, and ankle-foot orthoses is adequate. If a plantigrade weight-bearing surface cannot be achieved, surgical stabilization or reconstruction requires rigid stabilization in a poor biomechanical environment using tools that are not designed for structures as small as the foot. The controversies presented to clinicians charged with care of this difficult patient population are as follows: 1. When to allow weight bearing in the acute phase of the disease process. 2. Whether prefabricated devices are as successful as the total contact cast in the acute phase. 3. Early surgical stabilization versus accommodation when deformity first develops. 4. Late reconstruction versus accommodation or amputation in the deformed late stages.

Guidelines for diabetic foot care. The Diabetes Committee of the American Orthopaedic Foot and Ankle Society.

Foot infection is the most common reason for hospital admission of patients with diabetes in the United States. Foot ulceration leads to deep infection, sepsis, and lower extremity amputation. Prophylactic foot care has been shown to decrease patient morbidity, decrease the utilization of expensive resources, and decrease the risk for amputation and premature death. The Diabetes Committee of the American Orthopaedic Foot and Ankle Society has developed guidelines for implementing this type of prophylactic foot care. The guidelines are arranged as follows: I. Screening for Patients Who Are at Risk for Developing Diabetic Foot Complications A. Risk Factors B. Components of Screening and Examination II. Patient Education III. Basic Treatment Guidelines A. Risk Categories B. Nail Care C. Ulcer Care IV. Referral Guidelines A. Vascular Surgery Consultation B. Orthopaedic Consultation C. Endocrinologist/Diabetologist Consultation D. Infectious Disease Consultation E. Radiologic Consultation F. Pedorthic Consultation V. Resources.

American Orthopaedic Foot and Ankle Society shoe survey of diabetic patients.

A one-page written survey was completed by 402 randomly selected patients with diabetes in five cities during a scheduled visit to their endocrinologist. Patients averaged 61.5 years of age and had been diagnosed with diabetes for 27.3 years. This study suggests that approximately 25% of adults with diabetes are at risk for developing foot ulcers, the precursor to deep infection leading to lower limb amputation. The goal at the inception of this project was to obtain benchmark data on the current level of prophylactic foot care being provided to adult patients with diabetes. The results of this survey suggest that most individuals with diabetes and their physicians are aware of potential diabetic foot morbidity, yet very few take advantage of prophylactic protective footware. Even fewer are presently taking advantage of benefits established through the Medicare Therapeutic Foot Bill. This survey highlights a substantial opportunity for improvement in the long-term care of individuals with diabetes.

Benchmark analysis of diabetic patients with neuropathic (Charcot) foot deformity.

During a 10-year period, 237 patients (129 women, 108 men) with a diagnosis of neuropathic (Charcot) arthropathy of the foot and ankle were treated in a tertiary care university hospital medical center. During this period, 115 of the patients (48.5%) were treated nonoperatively as outpatients with local skin and nail care, accommodative shoe wear, and custom foot orthoses. A total of 120 (50.6%) underwent 143 operations. Surgery included 21 major limb amputations, 29 ankle fusions, 26 hindfoot fusions, 23 exostectomies, and 23 debridements for osteomyelitis. It is widely accepted that patients with diabetes are at risk for developing foot ulcers, which can lead to lower extremity amputation. Within the population of diabetic patients, it is widely accepted that patients with neuropathic (Charcot) arthropathy of the foot and ankle have one of the highest likelihoods of having to undergo lower extremity amputation. The current emphasis in care of the foot of a diabetic patient involves a multidisciplinary team approach combining patient education, skin and nail care, and accommodative shoe wear. As data from prophylactic programs become available, resource allocation and cost of care can be compared with this benchmark baseline. This benchmark analysis can be used by those who are responsible for allocating resources and projecting healthcare costs for this "high utilization"/high risk patient population.