Annunziato Amendola

Prospective Controlled Trial of STAR Total Ankle Replacement versus Ankle Fusion: Initial Results

Background: Mobile-bearing ankle replacements have become popular outside of the United States over the past two decades. The goal of the present study was to perform a prospective evaluation of the safety and efficacy of a mobile-bearing prosthesis to treat end stage ankle arthritis. We report the results of three separate cohorts of patients: a group of Scandanavian Total Ankle Replacement (STAR) patients and a control group of ankle fusion patients (the Pivotal Study Groups) and another group of STAR total ankle patients (Continued Access Group) whose surgery was performed following the completion of enrollment in the Pivotal Study. Materials and Methods: The Pivotal Study design was a non-inferiority study using ankle fusion as the control. A non-randomized multi-centered design with concurrent fusion controls was used. We report the initial perioperative findings up to 24 months following surgery. For an individual patient to be considered an overall success, all of the following criteria needed to be met: a) a 40-point improvement in total Buechel-Pappas ankle score, b) no device failures, revisions, or removals, c) radiographic success, and d) no major complications. In the Pivotal Study (9/00 to 12/01), 158 ankle replacement and 66 arthrodesis procedures were performed; in the Continued Access Study (4/02 to 10/06), 448 ankle replacements were performed, of which 416 were at minimum 24 months post-surgery at time of the database closure. Results: Major complications and need for secondary surgical intervention were more common in the Pivotal Study arthroplasty group than the Pivotal Study ankle fusion group. In the Continued Access Group, secondary procedures performed on these arthroplasty patients decreased by half when compared with the Pivotal Arthroplasty Group. When the Pivotal Groups were compared, treatment efficacy was higher for the ankle replacement group due to improvement in functional scores. Pain relief was equivalent between fusion and replacement patients. The hypothesis of non-inferiority of ankle replacement was met for overall patient success. Conclusion: By 24 months, ankles treated with STAR ankle replacement (in both the Pivotal and Continued Access Groups) had better function and equivalent pain relief as ankles treated with fusion. Level of Evidence: II, Prospective Controlled Comparative Surgical Trial

The effect of bracing on varus gonarthrosis.

BACKGROUND The purpose of this study was to compare a custom-made valgus-producing functional knee (unloader) brace, a neoprene sleeve, and medical treatment only (control group) with regard to their ability to improve the disease-specific quality of life and the functional status of patients who had osteoarthritis in association with a varus deformity of the knee (varus gonarthrosis). METHODS The study design was a prospective, parallel-group, randomized clinical trial. Patients who had varus gonarthrosis were screened for eligibility. The criteria for exclusion included arthritides other than osteoarthritis; an operation on the knee within the previous six months; symptomatic disease of the hip, ankle, or foot; a previous fracture of the tibia or femur; morbid obesity (a body-mass index of more than thirty-five kilograms per square meter); skin disease; peripheral vascular disease or varicose veins that would preclude use of a brace; a severe cardiovascular deficit; blindness; poor English-language skills; and an inability to apply a brace because of physical limitations such as arthritis in the hand or an inability to bend over. Treatment was assigned on the basis of a computer-generated block method of randomization with use of sealed envelopes. The patients were stratified according to age (less than fifty years or at least fifty years), deformity (the mechanical axis in less than 5 degrees of varus or in at least 5 degrees of varus), and the status of the anterior cruciate ligament (torn or intact). The patients were randomly assigned to one of three treatment groups: medical treatment only (control group), medical treatment and use of a neoprene sleeve, or medical treatment and use of an unloader brace. The disease-specific quality of life was measured with use of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR), and function was assessed with use of the six-minute walking and thirty-second stair-climbing tests. The primary outcome measure consisted of an analysis of covariance of the change in scores between the baseline and six-month evaluations. RESULTS One hundred and nineteen patients were randomized. The control group consisted of forty patients (thirty-one men and nine women; mean age, 60.9 years); the neoprene-sleeve group, of thirty-eight patients (twenty-seven men and eleven women; mean age, 58.2 years); and the unloader-brace group, of forty-one patients (twenty-eight men and thirteen women; mean age, 59.5 years). Nine patients withdrew from the study. At the six-month follow-up evaluation, there was a significant improvement in the disease-specific quality of life (p = 0.001) and in function (p< or =0.001) in both the neoprene-sleeve group and the unloader-brace group compared with the control group. There was a significant difference between the unloader-brace group and the neoprene-sleeve group with regard to pain after both the six-minute walking test (p = 0.021) and the thirty-second stair-climbing test (p = 0.016). There was a strong trend toward a significant difference between the unloader-brace group and the neoprene-sleeve group with regard to the change in the WOMAC aggregate (p = 0.062) and WOMAC physical function scores (p = 0.081). CONCLUSIONS The results indicate that patients who have varus gonarthrosis may benefit significantly from use of a knee brace in addition to standard medical treatment. The unloader brace was, on the average, more effective than the neoprene sleeve. The ideal candidates for each of these bracing options remain to be identified.

Allograft Versus Autograft Anterior Cruciate Ligament Reconstruction: Predictors of Failure From a MOON Prospective Longitudinal Cohort.

Background: Tearing an anterior cruciate ligament (ACL) graft is a devastating occurrence after ACL reconstruction (ACLR). Identifying and understanding the independent predictors of ACLR graft failure is important for surgical planning, patient counseling, and efforts to decrease the risk of graft failure. Hypothesis: Patient and surgical variables will predict graft failure after ACLR. Study Design: Prospective cohort study. Methods: A multicenter group initiated a cohort study in 2002 to identify predictors of ACLR outcomes, including graft failure. First, to control for confounders, a single surgeon’s data (n = 281 ACLRs) were used to develop a multivariable regression model for ACLR graft failure. Evaluated variables were graft type (autograft vs allograft), sex, age, body mass index, activity at index injury, presence of a meniscus tear, and primary versus revision reconstruction. Second, the model was validated with the rest of the multicenter study’s data (n = 645 ACLRs) to evaluate the generalizability of the model. Results: Patient age and ACL graft type were significant predictors of graft failure for all study surgeons. Patients in the age group of 10 to 19 years had the highest percentage of graft failures. The odds of graft rupture with an allograft reconstruction are 4 times higher than those of autograft reconstructions. For each 10-year decrease in age, the odds of graft rupture increase 2.3 times. Conclusion: There is an increased risk of ACL graft rupture in patients who have undergone allograft reconstruction. Younger patients also have an increased risk of ACL graft failure. Clinical Relevance: Given these risks for ACL graft rupture, allograft ACLRs should be performed with caution in the younger patient population.

Operative versus Nonoperative Treatment of Acute Achilles Tendon Ruptures A Multicenter Randomized Trial Using Accelerated Functional Rehabilitation

BACKGROUND To date, studies directly comparing the rerupture rate in patients with an Achilles tendon rupture who are treated with surgical repair with the rate in patients treated nonoperatively have been inconclusive but the pooled relative risk of rerupture favored surgical repair. In all but one study, the limb was immobilized for six to eight weeks. Published studies of animals and humans have shown a benefit of early functional stimulus to healing tendons. The purpose of the present study was to compare the outcomes of patients with an acute Achilles tendon rupture treated with operative repair and accelerated functional rehabilitation with the outcomes of similar patients treated with accelerated functional rehabilitation alone. METHODS Patients were randomized to operative or nonoperative treatment for acute Achilles tendon rupture. All patients underwent an accelerated rehabilitation protocol that featured early weight-bearing and early range of motion. The primary outcome was the rerupture rate as demonstrated by a positive Thompson squeeze test, the presence of a palpable gap, and loss of plantar flexion strength. Secondary outcomes included isokinetic strength, the Leppilahti score, range of motion, and calf circumference measured at three, six, twelve, and twenty-four months after injury. RESULTS A total of 144 patients (seventy-two treated operatively and seventy-two treated nonoperatively) were randomized. There were 118 males and twenty-six females, and the mean age (and standard deviation) was 40.4 ± 8.8 years. Rerupture occurred in two patients in the operative group and in three patients in the nonoperative group. There was no clinically important difference between groups with regard to strength, range of motion, calf circumference, or Leppilahti score. There were thirteen complications in the operative group and six in the nonoperative group, with the main difference being the greater number of soft-tissue-related complications in the operative group. CONCLUSIONS This study supports accelerated functional rehabilitation and nonoperative treatment for acute Achilles tendon ruptures. All measured outcomes of nonoperative treatment were acceptable and were clinically similar to those for operative treatment. In addition, this study suggests that the application of an accelerated-rehabilitation nonoperative protocol avoids serious complications related to surgical management.

Risk of Tearing the Intact Anterior Cruciate Ligament in the Contralateral Knee and Rupturing the Anterior Cruciate Ligament Graft During the First 2 Years After Anterior Cruciate Ligament Reconstruction A Prospective MOON Cohort Study

Background The risk of tear of the intact anterior cruciate ligament in the contralateral knee after anterior cruciate ligament reconstruction of the opposite knee and the incidence of rupturing the anterior cruciate ligament graft during the first 2 years after surgery have not been extensively studied in a prospective manner. Clinicians have hypothesized that the opposite normal knee is at equal or increased risk compared with the risk of anterior cruciate ligament graft rupture in the operated knee. Hypothesis The risk of anterior cruciate ligament graft rupture and contralateral normal knee anterior cruciate ligament rupture at 2-year follow-up is equal. Study Design Cohort study; Level of evidence, 2. Methods The Multicenter Orthopaedic Outcome Network (MOON) database of a prospective longitudinal cohort of anterior cruciate ligament reconstructions was used to determine the number of anterior cruciate ligament graft ruptures and tears of the intact anterior cruciate ligament in the contralateral knee at 2-year follow-up. Two-year follow-up consisted of a phone interview and review of operative reports. Results Two-year data were obtained for 235 of 273 patients (86%). There were 14 ligament disruptions. Of these, 7 were tears of the intact anterior cruciate ligament in the contralateral knee (3.0%) and 7 were anterior cruciate ligament graft failures (3.0%). Conclusion The contralateral normal knee anterior cruciate ligament is at a similar risk of anterior cruciate ligament tear (3.0%) as the anterior cruciate ligament graft after primary anterior cruciate ligament reconstruction (3.0%).

The Prognosis and Predictors of Sports Function and Activity at Minimum 6 Years After Anterior Cruciate Ligament Reconstruction A Population Cohort Study

Background: The predictors of anterior cruciate ligament reconstruction (ACLR) outcome at 6 years as measured by validated patient-based outcome instruments are unknown. Hypothesis: Certain variables evaluated at the time of ACLR will predict return to sports function (as measured by the International Knee Documentation Committee [IKDC] questionnaire and the Knee injury and Osteoarthritis Outcome Score [KOOS] Sports and Recreation subscale), knee-related quality of life (KOOS Knee Related Quality of Life subscale), and activity level (Marx Activity Scale). Potential predictor variables include demographic factors, surgical technique and graft choice for ACLR, and intra-articular injuries and treatment. Study Design: Cohort study; Level of evidence, 2. Methods: All patients with unilateral ACLRs from 2002 currently enrolled in the MOON (Multicenter Orthopaedic Outcomes Network) cohort were evaluated. Patients completed the validated outcome instruments preoperatively. Physicians documented intra-articular pathologic abnormalities, treatment, and surgical techniques used at the time of surgery. At 2 and 6 years postoperatively, patients completed the same validated outcome instruments. Results: Follow-up was obtained at 2 years (88%) and at 6 years (84%). The cohort was 57% male with a median age of 23 years at enrollment. The ability to perform sports function was maintained at 6 years, but the Marx activity level continued to decline from baseline. Revision ACLR and use of allograft predicted worse outcomes on the IKDC and both KOOS subscales. Lateral meniscus treatment, smoking status, and body mass index at baseline were each predictors on 2 of 3 scales. The predictors of lower activity level were revision ACLR and female sex. Conclusion: Six years after ACLR, patients could perform sports-related functions and maintain a high knee-related quality of life similar to their 2-year level, although their physical activity level (Marx) dropped over time. Choosing autograft rather than allograft, not smoking, and having normal body mass index are advised to improve long-term outcomes.

Is stress radiography necessary in the diagnosis of acute or chronic ankle instability

BACKGROUND Clinicians often use the talar tilt (TT) and anterior drawer (AD) stress x-rays to diagnose acute or chronic mechanical ankle instability. However, the wide range of TT and AD values in normal and injured ankles makes interpretation of the test results difficult. OBJECTIVE To critically review the literature and determine the accuracy of stress radiography in the diagnosis of mechanical ankle instability. DATA SOURCES MEDLINE was searched for relevant articles published since 1966 using MEDLINE subject headings (MeSH) and textwords for English articles related to ankle injuries and radiography. Additional references were reviewed from the bibliographies of the retrieved articles. The total number of articles reviewed was 67. Of these, 8 studies met criteria for inclusion and were analyzed. STUDY SELECTION Only clinical studies that used surgical exploration as the gold standard for diagnosing lateral ligament rupture were evaluated for this study. Cadaver or laboratory studies were excluded. DATA EXTRACTION AND SYNTHESIS In reviewing the literature, pertinent strengths of the different study designs were emphasized. From these data, particular attention was paid to the diagnostic accuracy of each study in comparing TT and AD stress x-rays to surgical confirmation of lateral ligament rupture. MAIN RESULTS A total of eight prospective clinical series satisfied the inclusion criteria. Seven of the eight assessed acute ankle instability as the outcome and one assessed chronic ankle instability. Of the seven studies that focused on acute ankle injuries, only one concluded significant benefit in using stress views to diagnose lateral ligament rupture. Three of the seven reported a positive relationship between stress radiography and surgical findings, although all six studies concluded that TT and AD stress x-rays are not reliable enough to make the diagnosis. The authors who assessed chronic ankle instability stated that TT and AD stress views combined were not useful in defining ankle instability. CONCLUSION The published data regarding TT and AD stress x-rays are too variable to determine accepted normal values compared with injured values. There are insufficient data for comparison of the use of mechanical versus manual techniques, or use of local anesthetic to facilitate the stress test. Because the treatment evolution of all acute ankle sprains is toward functional nonoperative treatment and because treatment does not depend on the degree of ankle instability on stress views, the TT and AD stress x-rays have no clinical relevance in the acute situation. In cases of chronic instability, the large variability in TT and AD values in both injured and noninjured ankles precludes their routine use.

The use of magnetic resonance imaging in exertional compartment syndromes

This prospective, double-blind study was carried out to assess the usefulness of magnetic resonance imaging (MRI) as a noninvasive method in the diagnosis of chronic compartment syndrome (CCS). As well, a new radiopharmaceutical known as methoxy isobutyl isoni trile that has been shown to be taken up by muscle in direct proportion to its blood flow was used to illustrate the possible pathophysiology of this syndrome. Twenty patients with a history of chronic leg pain and possible diagnosis of CCS and five normal volunteers had preexercise and postexercise MRI, nuclear medi cine imaging, and static and dynamic slit catheter pres sure studies. Nine patients had classic symptoms; only five of these nine had abnormal pressure studies. The other 11 patients had an element of pain at rest and had normal pressure studies. The nuclear blood flow studies were normal in all 25 legs tested in this study. Measurement of intrinsic MRI parameters T1 and T2 in the normal legs as well as in those with an atypical history showed a marked elevation with exercise and a gradual return to baseline postexercise that was similar to the pres sure curves. In the five patients with a clinical history and elevated pressures, four had abnormal MRI studies with failure of T1 to return to baseline values. Although these results demonstrate the potential of MRI as a tool for noninvasively monitoring muscle sta tus, clinical history and examination remain important in the diagnosis of CCS. This study indicates that the pathophysiology of exertional compartment syndrome does not appear to be related to ischemia.

Occult Osteochondral Lesions After Anterior Cruciate Ligament Rupture Six-Year Magnetic Resonance Imaging Follow-up Study

Twenty-three patients with acute anterior cruciate ligament injuries, normal radiographs, and occult osteochondral lesions revealed by magnetic resonance imaging were reviewed 6 years after initial injury and anterior cruciate ligament hamstring autograft reconstruction. Each patient completed the Mohtadi Quality of Life outcome measure for anterior cruciate ligament deficiency, underwent clinical examination, and had a repeat magnetic resonance imaging scan. The index and follow-up magnetic resonance imaging scans were compared with respect to cartilage thinning and marrow signal. A significant number of patients had evidence of cartilage thinning adjacent to the site of the initial osteochondral lesion. Marrow signal changes persisted in 15 (65%) of the patients. Clinical comparison of patients with normal cartilage with those who had cartilage thinning revealed similar results on both KT-1000 arthrometry and on the Mohtadi outcome measure. This suggests that the initial injury resulted in irreversible changes in the knee. Injuries causing marrow signal changes may result in an alteration in the load-bearing properties of subchondral bone, which in turn allow for changes in the overlying cartilage. Further follow-up will determine the clinical significance of changes detected by magnetic resonance imaging.

The Prognosis and Predictors of Sports Function and Activity at Minimum 6 Years After Anterior Cruciate Ligament Reconstruction

Background: The predictors of anterior cruciate ligament reconstruction (ACLR) outcome at 6 years as measured by validated patient-based outcome instruments are unknown. Hypothesis: Certain variables evaluated at the time of ACLR will predict return to sports function (as measured by the International Knee Documentation Committee [IKDC] questionnaire and the Knee injury and Osteoarthritis Outcome Score [KOOS] Sports and Recreation subscale), knee-related quality of life (KOOS Knee Related Quality of Life subscale), and activity level (Marx Activity Scale). Potential predictor variables include demographic factors, surgical technique and graft choice for ACLR, and intra-articular injuries and treatment. Study Design: Cohort study; Level of evidence, 2. Methods: All patients with unilateral ACLRs from 2002 currently enrolled in the MOON (Multicenter Orthopaedic Outcomes Network) cohort were evaluated. Patients completed the validated outcome instruments preoperatively. Physicians documented intra-articular pathologic abnormalities, treatment, and surgical techniques used at the time of surgery. At 2 and 6 years postoperatively, patients completed the same validated outcome instruments. Results: Follow-up was obtained at 2 years (88%) and at 6 years (84%). The cohort was 57% male with a median age of 23 years at enrollment. The ability to perform sports function was maintained at 6 years, but the Marx activity level continued to decline from baseline. Revision ACLR and use of allograft predicted worse outcomes on the IKDC and both KOOS subscales. Lateral meniscus treatment, smoking status, and body mass index at baseline were each predictors on 2 of 3 scales. The predictors of lower activity level were revision ACLR and female sex. Conclusion: Six years after ACLR, patients could perform sports-related functions and maintain a high knee-related quality of life similar to their 2-year level, although their physical activity level (Marx) dropped over time. Choosing autograft rather than allograft, not smoking, and having normal body mass index are advised to improve long-term outcomes.