Selection of knee radiographs for trials of structure-modifying drugs in patients with knee osteoarthritis: a prospective, longitudinal study of Lyon Schuss knee radiographs with the definition of adequate alignment of the medial tibial plateau

OBJECTIVE: The quality of medial tibial plateau (MTP) alignment, which is assessed by measuring the distance between the anterior and posterior margins (intermargin distance [IMD]) of the tibial plateau, and the reproducibility of alignment in serial radiographs are suggested to be key elements in determining the accuracy and sensitivity to change in knee radiographs in patients with tibiofemoral osteoarthritis (OA). We evaluated the influence of both MTP alignment and radiograph superimposition on the sensitivity to change in radiographic joint space narrowing (JSN) in knee OA. METHODS: The study group comprised 106 patients with knee pain (73 with OA). Lyon schuss radiographic images of the knee were obtained twice (at baseline [month 0] and 12 months later), using a standardized radiographic procedure. Computerized measurement of the IMD for the assessment of MTP alignment was compared with the grading of MTP alignment by 2 observers using a 5-point scale (excellent, good, fair, poor, bad). To obtain the rate of JSN, computerized measurement of the joint space width was performed at month 0 and month 12. The sensitivity of the joint space width to change over 1 year was evaluated by the standardized response mean (SRM). RESULTS: The mean (+/-SD) IMD was 1.2 +/- 0.9 mm. The correlation between scoring and computer measurement of MTP alignment was highly significant. The cutoff value for satisfactory alignment (excellent or good) was an IMD of 1.2 mm at month 0 and/or month 12. CONCLUSION: The quality of MTP alignment at both baseline and the end point highly influences the sensitivity to change in radiographic JSN in knee OA. To obtain relevant data, only radiographs showing an IMD of 相似文献   

Effect of alignment of the medial tibial plateau and X‐ray beam on apparent progression of osteoarthritis in the standing anteroposterior knee radiograph

Objective

Previous studies of knee osteoarthritis (OA) have yielded variable estimates of the rate of joint space narrowing (JSN) in the standing anteroposterior (AP) radiograph, due largely to longitudinal changes in the alignment of the medial tibial plateau (MTP) and x‐ray beam. To characterize this bias, we examined serial radiographs of subjects with knee OA in population‐based and clinical OA cohorts from 3 locations in the United States and the United Kingdom.

Methods

Radiographic features of knee OA (e.g., osteophytosis, JSN) and MTP alignment in 428 OA knees were evaluated by consensus of 2 readers. Alignment was considered satisfactory if the anterior and posterior margins of the MTP were superimposed within 1 mm. Readers were blinded to subject identity, and films were read in random order. The minimum medial joint space width was also measured manually (standard error of repeated measurements 0.20 mm) in serial knee images.

Results

Only 14% of serial radiographs exhibited alignment of the MTP in both images. In OA knees with satisfactory alignment in both images, the mean rate of JSN over 2–3 years (0.26 mm/year) was significantly larger (P = 0.004) than that in OA knees with misalignment in 1 or both radiographs and was 86% more rapid than the mean JSN in all OA knees. Moreover, the within‐group standard deviation of JSN was significantly smaller among knees with reproduced alignment of the MTP than in knees in which misalignment occurred in 1 or both images (P = 0.006).

Conclusion

Poor standardization of knee positioning in serial standing AP radiographs in previous studies of OA progression has obscured the rate and variability of articular cartilage loss in subjects with knee OA. True JSN (i.e., JSN that is not attributable to longitudinal changes in the alignment of the MTP with the x‐ray beam in serial radiographic examinations) may occur more rapidly, and with less between‐subject variability, than that previously thought to be characteristic of knee OA.

     

Effect of alignment of the medial tibial plateau and x-ray beam on apparent progression of osteoarthritis in the standing anteroposterior knee radiograph

OBJECTIVE: Previous studies of knee osteoarthritis (OA) have yielded variable estimates of the rate of joint space narrowing (JSN) in the standing anteroposterior (AP) radiograph, due largely to longitudinal changes in the alignment of the medial tibial plateau (MTP) and x-ray beam. To characterize this bias, we examined serial radiographs of subjects with knee OA in population-based and clinical OA cohorts from 3 locations in the United States and the United Kingdom. METHODS: Radiographic features of knee OA (e.g., osteophytosis, JSN) and MTP alignment in 428 OA knees were evaluated by consensus of 2 readers. Alignment was considered satisfactory if the anterior and posterior margins of the MTP were superimposed within 1 mm. Readers were blinded to subject identity, and films were read in random order. The minimum medial joint space width was also measured manually (standard error of repeated measurements 0.20 mm) in serial knee images. RESULTS: Only 14% of serial radiographs exhibited alignment of the MTP in both images. In OA knees with satisfactory alignment in both images, the mean rate of JSN over 2-3 years (0.26 mm/year) was significantly larger (P = 0.004) than that in OA knees with misalignment in 1 or both radiographs and was 86% more rapid than the mean JSN in all OA knees. Moreover, the within-group standard deviation of JSN was significantly smaller among knees with reproduced alignment of the MTP than in knees in which misalignment occurred in 1 or both images (P = 0.006). CONCLUSION: Poor standardization of knee positioning in serial standing AP radiographs in previous studies of OA progression has obscured the rate and variability of articular cartilage loss in subjects with knee OA. True JSN (i.e., JSN that is not attributable to longitudinal changes in the alignment of the MTP with the x-ray beam in serial radiographic examinations) may occur more rapidly, and with less between-subject variability, than that previously thought to be characteristic of knee OA.     

Assessing bone loss on radiographs of the knee in osteoarthritis: A cross‐sectional study

Objective

The only established system to grade subchondral bone attrition in knee osteoarthritis (OA) has low interobserver reliability. In this study, our aim was to convert this system into a reliable tool for the assessment of subchondral bone loss in knee OA.

Methods

Templates that were designed to outline the normal contours of the knee were overlaid onto conventional radiographs of a random sample of 100 knees of OA patients who were awaiting total knee replacement (TKR). Seventy‐five films from individuals with chronic knee pain who were not awaiting TKR and 75 films from asymptomatic control subjects were also assessed. Bone loss was graded from 0 (no attrition) to 3 (severe attrition of >10 mm); other established radiologic features were also graded. Spearman's rho was used to determine the correlation of attrition scores with other features, and logistic regression was used to explore whether definite bone attrition was associated with night pain.

Results

The inter‐ and intraobserver reliability values were high for attrition scores and for the presence of definite attrition (score ≥2). Bone attrition was evident in 62% of films from patients awaiting TKR, in 9% of films from individuals with chronic knee pain who were not awaiting TKR, and in 1% of films from controls. In all groups, the correlation between attrition and other features was weak to moderate. There was a nonsignificant association between definite bone attrition and night pain.

Conclusion

Bone attrition is an additional dimension of knee OA that can be measured reliably. Definite attrition may be associated with night pain.

     

Predictors of single‐leg standing balance in individuals with medial knee osteoarthritis

Objective

To identify factors related to single‐leg standing balance in individuals with medial compartment knee osteoarthritis (OA).

Methods

This cross‐sectional study assessed clinical, demographic, and biomechanical measures in 57 individuals and their relationships with single‐leg standing balance. Differences in age, mass, symptoms, knee pain, radiographic severity, lower extremity alignment, and hip and knee extension as well as hip abduction torques were compared between those who could and could not perform 3 trials of single‐leg standing balance. Multiple regression was used to identify predictors of center of pressure (COP) path length in those who could complete the task.

Results

Thirty‐four individuals (60%) successfully completed all 3 single‐leg standing balance trials and were significantly younger (P = 0.003) than those who could not. No other variable was significantly different between the groups. Disease severity, number of painful knees, lower extremity alignment, pain intensity, and quadriceps torque were all significant predictors of COP path length. Specifically, better single‐leg standing balance (smaller COP path length) was related to more severe radiographic changes and stronger quadriceps, those with bilateral symptoms, and to less varus malalignment and knee pain.

Conclusion

Single‐leg standing balance in those with medial knee OA is related to the modifiable factors lower extremity alignment, knee pain, and quadriceps strength. Given the reduced balancing ability in this patient population, interventions targeting these factors are necessary.     

Evaluation of the structure‐modifying effects of diacerein in hip osteoarthritis: ECHODIAH,a three‐year,placebo‐controlled trial

Objective

To evaluate the ability of diacerein, an interleukin‐1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis (OA).

Methods

In this randomized, double‐blind, placebo‐controlled 3‐year study, 507 patients with primary OA of the hip (by the American College of Rheumatology criteria) received diacerein (50 mg twice a day) or placebo. The minimal hip joint space width was measured by a central reader on yearly pelvic radiographs, using a 0.1‐mm–graduated magnifying glass.

Results

Baseline characteristics were comparable in the 2 treatment groups (255 patients receiving diacerein, 252 receiving placebo); 238 patients (47%) discontinued the study, mainly because of adverse events in the diacerein group (25% versus 12% with placebo) and because of inefficacy in the placebo group (14% versus 7% with diacerein). The percentage of patients with radiographic progression, defined by a joint space loss of at least 0.5 mm, was significantly lower in patients receiving diacerein than in patients receiving placebo, both in the intent‐to‐treat analysis and in the completer analysis (50.7% versus 60.4% [P = 0.036] and 47.3% versus 62.3% [P = 0.007], respectively). In those patients who completed 3 years of treatment, the rate of joint space narrowing was significantly lower with diacerein (mean ± SD 0.18 ± 0.25 mm/year versus 0.23 ± 0.23 mm/year with placebo; P = 0.042). Diacerein had no evident effect on the symptoms of OA in this study. However, a post hoc covariate analysis that took into account the use of analgesics and antiinflammatory drugs showed an effect of diacerein on the Lequesne functional index. Diacerein was well tolerated during the 3‐year study. The most frequent adverse events were transient changes in bowel habits.

Conclusion

This study confirms previous clinical findings indicating that the demonstration of a structure‐modifying effect in hip OA is feasible, and shows, for the first time, that treatment with diacerein for 3 years has a significant structure‐modifying effect as compared with placebo, coupled with a good safety profile. The clinical relevance of these findings requires further investigation.

     

Test–retest reliability of the peak knee adduction moment during walking in patients with medial compartment knee osteoarthritis

Objective

To estimate the test–retest reliability of the peak external knee adduction moment during walking in patients with medial compartment knee osteoarthritis (OA), and to describe the interpretation of the reported values.

Methods

A total of 31 patients diagnosed with knee OA confined primarily to the medial compartment underwent quantitative gait analyses during 2 separate test sessions at least 24 hours apart and within 1 week. The peak knee adduction moment was calculated for each patient at each session based on the mean of 5 walking trials. Reliability was estimated using the intraclass correlation coefficient (ICC_2,1) and the standard error of measurement (SEM).

Results

The mean difference in peak adduction moments between test sessions was 0.1% body weight × height (BW × ht; 95% confidence interval [95% CI] ?0.1, 0.3). The point estimate for the ICC was 0.86 (95% CI 0.73, 0.96). The point estimate for the SEM was 0.36% BW × ht (95% CI 0.29, 0.48).

Conclusion

The ICC suggests that the peak knee adduction moment is appropriate for use when distinguishing among patients, for example, in studies of various interventions intended to decrease dynamic load on the knee medial compartment. The SEM illustrates the importance of considering measurement error and incorporating confidence levels when interpreting an individual patient's peak knee adduction moment value.

     

Test-retest reliability of the peak knee adduction moment during walking in patients with medial compartment knee osteoarthritis

OBJECTIVE: To estimate the test-retest reliability of the peak external knee adduction moment during walking in patients with medial compartment knee osteoarthritis (OA), and to describe the interpretation of the reported values. METHODS: A total of 31 patients diagnosed with knee OA confined primarily to the medial compartment underwent quantitative gait analyses during 2 separate test sessions at least 24 hours apart and within 1 week. The peak knee adduction moment was calculated for each patient at each session based on the mean of 5 walking trials. Reliability was estimated using the intraclass correlation coefficient (ICC(2,1)) and the standard error of measurement (SEM). RESULTS: The mean difference in peak adduction moments between test sessions was 0.1% body weight x height (BW x ht; 95% confidence interval [95% CI] -0.1, 0.3). The point estimate for the ICC was 0.86 (95% CI 0.73, 0.96). The point estimate for the SEM was 0.36% BW x ht (95% CI 0.29, 0.48). CONCLUSION: The ICC suggests that the peak knee adduction moment is appropriate for use when distinguishing among patients, for example, in studies of various interventions intended to decrease dynamic load on the knee medial compartment. The SEM illustrates the importance of considering measurement error and incorporating confidence levels when interpreting an individual patient's peak knee adduction moment value.     

Comparison of two hyaluronan drugs in patients with advanced osteoarthritis of the knee. A prospective, randomized, double-blind study with long term follow-up

OBJECTIVES: To compare the long-term effects of high and low molecular weight hyaluronic acid (HA) applications in severe (Kellgren Lawrence stage III) osteoarthritis (OA) of the knee. METHODS: In a prospective clinical trial 184 knees (92 patients) with radiographic Kellgren Lawrence stage III OA were randomized to receive either 3 intra-articular high molecular weight HA (Hylan G-F 20) injections or 3 low molecular weight HA (Orthovisc) injections at one-week intervals. Patients were evaluated by the Hospital for Special Surgery (HSS) Knee Score and were followed-up for 12 months. RESULTS: The total HSS score in high molecular weight HA patients improved from 71.8+/-11.6 to 86.7+/-11.6 and in low molecular weight HA patients from 66.7+/-11.0 to 86.6+/-9.1 at the end of the trial (p < 0.01). There were no statistically significant differences between the groups and both had improved in all parameters at the latest follow-up (p = 0.000). CONCLUSIONS: Three intra-articular injections at intervals of 1 week of both HA preparations resulted in a pronounced reduction in pain and improved function as measured by the HSS score during a period of 52 weeks, without complications.     

Evidence for increased bone resorption in patients with progressive knee osteoarthritis: longitudinal results from the Chingford study

OBJECTIVE: Several studies have suggested that increased subchondral bone turnover is a determinant of progression of osteoarthritis (OA). To test this hypothesis, the level of urinary N-terminal type I collagen telopeptides (NTx) and C-terminal type I collagen telopeptides (CTx), which are validated markers of bone resorption, was measured at 3 different time points in a subset of patients from the Chingford study. METHODS: The original Chingford study population comprised 1,003 women. From this group, postmenopausal women not receiving any bone-modifying medication who had a baseline knee radiograph and a repeat radiograph 4 years later, and for whom a baseline lumbar spine bone mineral density (BMD) measurement was available, were identified and separated into 4 groups as follows: controls (n = 50), progressive OA (n = 71), nonprogressive OA (n = 36), and osteoporosis (n = 59). NTx and CTx were measured in urine samples collected at baseline, year 1, and year 2. RESULTS: Patient age and years since menopause were similar among groups at baseline. As expected, both body mass index (BMI) and BMD were lowest in patients with osteoporosis. Median resorption marker levels over the 3 time points were 31-87% higher in patients with either progressive OA or osteoporosis than in controls and patients with nonprogressive OA (P < 0.01, except for levels of CTx in patients with progressive OA versus nonprogressive OA). Levels of NTx and CTx did not differ significantly between women with progressive OA (defined either by the presence of osteophytes or by joint space narrowing) and those with osteoporosis or between controls and women with nonprogressive OA. Results were essentially unchanged after adjustment for age, BMI, BMD, and past use of hormone replacement therapy, or when NTx and CTx values at each time point were analyzed separately. CONCLUSION: Our data demonstrate that bone resorption is increased in patients with progressive knee OA and is not increased in those with nonprogressive knee OA. The increase in bone resorption seen in patients with progressive knee OA is similar to that observed in patients with osteoporosis. Altered bone turnover may be a diagnostic or therapeutic target in patients with progressive OA.     

A comparative study on the effect of the insole materials with subtalar strapping in patients with medial compartment osteoarthritis of the knee

Abstract

This study was conducted to assess the symptomatic effects of the insole with an elevation of 12?mm composed of urethane (urethane insole) or of sponge rubber (rubber insole) with subtalar strapping in patients with medial compartment osteoarthritis of the knee (knee OA). The setting was an outpatient clinic. Eighty-four patients with knee OA were prospectively randomized, and evaluated and treated with the urethane or rubber insole for 4 weeks. Randomization was performed according to birth date and each participant was categorized into the urethane group or the rubber group. The percentage of remission of Lequesne index of severity for knee OA was compared between urethane and rubber insole groups at the conclusion of the study. Participants were asked to report adverse effects of use of the respective insoles. The percentage of remission was significantly improved in the urethane insole group (n = 42) compared with the rubber insole group (n = 42) (P = 0.001). Adverse effects were more common in the rubber insole group (17 out of 42, 40.5%) than in the urethane insole group (8 out of 42, 19.0%), and this was statistically significant (P = 0.028). The inserted insole in combination with subtalar strapping had a more natural form-fit to the sole than the insole insert alone. In our study of the subtalar strapping insole, an insole composed of urethane, was more comfortable than that of rubber sponge.     

A comparative study on the effect of the insole materials with subtalar strapping in patients with medial compartment osteoarthritis of the knee

This study was conducted to assess the symptomatic effects of the insole with an elevation of 12 mm composed of urethane (urethane insole) or of sponge rubber (rubber insole) with subtalar strapping in patients with medial compartment osteoarthritis of the knee (knee OA). The setting was an outpatient clinic. Eighty-four patients with knee OA were prospectively randomized, and evaluated and treated with the urethane or rubber insole for 4 weeks. Randomization was performed according to birth date and each participant was categorized into the urethane group or the rubber group. The percentage of remission of Lequesne index of severity for knee OA was compared between urethane and rubber insole groups at the conclusion of the study. Participants were asked to report adverse effects of use of the respective insoles. The percentage of remission was significantly improved in the urethane insole group (n = 42) compared with the rubber insole group (n = 42) (P = 0.001). Adverse effects were more common in the rubber insole group (17 out of 42, 40.5%) than in the urethane insole group (8 out of 42, 19.0%), and this was statistically significant (P = 0.028). The inserted insole in combination with subtalar strapping had a more natural form-fit to the sole than the insole insert alone. In our study of the subtalar strapping insole, an insole composed of urethane, was more comfortable than that of rubber sponge. Potential conflict of interest: Dr. Toda owns a patent, U.S. Patent No. 6,585,674 B2, for the insole with subtalar strapping used in this study. The abstract of this work was presented at the 48th General Assembly and Scientific Meeting of the Japanese College of Rheumatology at Okayama, Japan, in 2004.     

Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radiographic progression in patients with medial compartment osteoarthritis of the knee: Results of the two‐year multinational knee osteoarthritis structural arthritis study

Objective

Bisphosphonates have slowed the progression of osteoarthritis (OA) in animal models and have decreased pain in states of high bone turnover. The Knee OA Structural Arthritis (KOSTAR) study, which is the largest study to date investigating a potential structure‐modifying OA drug, tested the efficacy of risedronate in providing symptom relief and slowing disease progression in patients with knee OA.

Methods

The study group comprised 2,483 patients with medial compartment knee OA and 2–4 mm of joint space width (JSW), as determined using fluoroscopically positioned, semiflexed‐view radiography. Patients were enrolled in 2 parallel 2‐year studies in North America and the European Union. These studies evaluated the efficacy of risedronate at dosages of 5 mg/day, 15 mg/day, 35 mg/week (in Europe), and 50 mg/week (in North America) compared with placebo in reducing signs and symptoms, as measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and patient global assessment (PGA) scores, and in slowing radiographic progression.

Results

A reduction of ∼20% in signs and symptoms, as measured by WOMAC subscales and PGA scores, was observed in all groups, with no treatment effect of risedronate demonstrated. Risedronate did not significantly reduce radiographic progression as measured by decreased JSW or using a dichotomous definition of progression (joint space loss of ≥0.6 mm). Thirteen percent of patients receiving placebo demonstrated significant disease progression over 2 years. A dose‐dependent reduction in the level of C‐terminal crosslinking telopeptide of type II collagen, a cartilage degradation marker associated with progressive OA, was seen in patients who received risedronate. No increase in the number of adverse events was demonstrated for risedronate compared with placebo.

Conclusion

Although risedronate (compared with placebo) did not improve signs or symptoms of OA, nor did it alter progression of OA, a reduction in the level of a marker of cartilage degradation was observed. A sustained clinically relevant improvement in signs and symptoms was observed in all treatment and placebo groups.

     

Usefulness of an insole with subtalar strapping for analgesia in patients with medial compartment osteoarthritis of the knee

OBJECTIVE: To assess the effect of an insole with subtalar strapping on patients with medial compartment osteoarthritis (OA) of the knee. METHODS: Novel lateral wedged insoles with elastic subtalar strapping (the subtalar strapping support group) and ankle supporters with a lateral wedged heel insert (the sock-type ankle support group) were prepared. Eighty-eight female outpatients with knee OA were treated with 1 of the 2 insoles for 8 weeks. Femorotibial angle was assessed by standing radiographs with and without unilateral insole use for each subject. Symptoms of knee OA were evaluated according to the severity index of Lequesne et al at baseline and at the final assessment. RESULTS: Participants wearing the insole with subtalar strapping (n = 42) demonstrated significantly decreased femorotibial angle (an average of change: -3.1 degrees +/- 2.5 degrees, P < 0.0001), but a significant difference was not found in the sock-type ankle support group (n = 46; -0.4 degrees +/- 1.1 degrees, P > 0.05). In the subtalar strapping support group, pain during bed rest with full extension of the knee (P < 0.0001), pain after getting up (P = 0.04), pain on getting up from a seated position (P = 0.021), maximum distance walked (P = 0.009), and aggregate severity score (P < 0.0001) were significantly improved compared with baseline. In contrast, significant symptomatic improvement was detected only in the aggregate score (P = 0.016) in the sock-type ankle support group, but not in any of the 10 specific categories. CONCLUSION: The lateral wedged insole with subtalar strapping induces correction of the femorotibial angle and symptomatic relief in patients with varus-deformity knee OA.