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PubMed2005

Urinary CTX-II levels are associated with radiographic subtypes of osteoarthritis in hip, knee, hand, and facet joints in subject with familial osteoarthritis at multiple sites: the GARP study.

OBJECTIVE: To assess the relation between the urinary concentrations of type II collagen C-telopeptide (UCTX-II) and radiographic signs of osteoarthritis (ROA) in the GARP (Genetics, Arthrosis and Progression) study. METHODS: UCTX-II levels were measured in GARP study participants, who are sibling pairs predominantly with symptomatic osteoarthritis at multiple sites. Kellgren and Lawrence scores were used to assess ROA in the knees, hips, hands, and vertebral facet joints, and spinal disc degeneration. A proportionate score was made for each joint location, based on the number of joints with ROA. The sum total ROA score represents a measure of cartilage abnormalities within each patient. By using linear mixed models the total ROA score and the joint site specific ROA scores were correlated with the UCTX-II level. RESULTS: In 302 subjects the mean (SD) and median (range) for UCTX-II were 265 (168) and 219 (1346) ng/mmol creatine, respectively. There was a significant association between the total ROA score and UCTX-II levels. Subsequent multivariate analysis showed that the joint site specific ROA score at all joint sites, except for spinal disc degeneration, contributed independently to this association. CONCLUSIONS: The total ROA score of GARP patients, representing cartilage abnormalities at the most prevalent ROA joint locations, showed an excellent correlation with UCTX-II levels. The specific ROA scores at the hip, hand, facet, and knee joints additively and independently explained this association. Even in patients with osteoarthritis at multiple sites, UCTX-II may be a sensitive quantitative marker of ROA.

Adult↗
PubMed1999

Measurement of matrix metalloproteinases (MMPs) and tissue inhibitor of metalloproteinases-1 (TIMP-1) in patients with knee osteoarthritis: comparison with generalized osteoarthritis.

OBJECTIVES: To compare plasma levels of matrix metalloproteinase (MMP)-3, MMP-9 and tissue inhibitor of metalloproteinases-1 (TIMP-1) between patients with knee osteoarthritis and normal subjects, to investigate whether the degree of knee joint involvement is related to those measurements, and to compare patients with and without generalized osteoarthritis. METHODS: Eighty-three women with knee osteoarthritis (OA patients) were studied. Plasma levels of MMP-3, MMP-9 and TIMP-1 were measured by enzyme immunoassays. Knee and hand radiographs were taken of all patients. The joints of the knee and hand were graded from 0 to 4 according to Kellgren and Lawrence criteria. All OA patients were divided into a generalized OA (GOA) group (n = 37) and a knee OA (KOA) group (n = 46) according to Doherty's criteria. MMPs and TIMP were also measured in 19 normal subjects. RESULTS: Plasma levels of MMP-3 and TIMP-1 were significantly higher in OA patients than in normal subjects. In contrast, MMP-9 was lower in OA patients than in normal subjects. Plasma levels of MMP-3 and MMP-9 were not influenced by the grade of knee OA. TIMP-1 was influenced by the grade of knee OA. Plasma levels of MMP-3 were significantly elevated in GOA compared to KOA. In contrast, there were no significant differences in plasma levels of MMP-9 and TIMP-1 between GOA and KOA. CONCLUSION: Since the plasma level of MMP-3 in GOA was higher than that in KOA patients, it may be a superior indicator for whole-joint degeneration.

Aged↗
PubMed2003

Partial meniscectomy in the presence of severe osteoarthritis does not hasten the symptomatic progression of osteoarthritis.

PURPOSE: This study had 2 aims: to determine whether arthroscopic partial meniscectomy improved symptoms in patients with a torn meniscus and severe degenerative change and to determine whether meniscectomy hastened the symptomatic progression of osteoarthritis in these patients. TYPE OF STUDY: An outcome study. METHODS: The study group consisted of 126 patients with Outerbridge grade IV degeneration (exposed bone) in the same compartment as a meniscal tear. These patients underwent arthroscopic partial meniscectomy. The control group consisted of 13 patients with exposed bone in the tibiofemoral compartment but intact menisci. They underwent washout. Data were obtained from a database of over 3,000 consecutive arthroscopies, patient medical records, and patients directly. Outcome was assessed a minimum of 12 months after surgery. RESULTS: Meniscectomy improved symptoms initially in 82 cases (65%). At a median of 52 months after meniscectomy, 41 patients (32%) had undergone further surgery (39 total knee arthroplasty, 1 unicompartmental knee arthroplasty, and 1 tibial osteotomy). Fifty patients (40%) reported subjective improvement. The subjective outcome assessment by patients was consistent with patient activity, use of nonsteroidal anti-inflammatory drugs, and the Lysholm score. Meniscectomy did not hasten the progression of osteoarthritis because more patients required joint replacement after washout (P =.04), and the mean time to further surgery was greater for meniscectomy than for washout (74 months [standard error, 4.11] and 50 months [standard error, 12.3], respectively, P =.067). CONCLUSIONS: Arthroscopic partial meniscectomy in the presence of Outerbridge grade IV degenerative change is likely to improve symptoms initially in patients with symptomatic meniscal tears and may provide lasting benefit. It does not appear to hasten the progression of the osteoarthritis in these patients.

Aged↗
PubMed1999

A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis. Rofecoxib Osteoarthritis Endoscopy Study Group.

BACKGROUND & AIMS: Prostaglandin production in the normal gastrointestinal tract, believed to be critical for mucosal integrity, is mediated by cyclooxygenase (COX)-1, whereas prostaglandin production at inflammatory sites seems to occur via induction of COX-2. We hypothesized that COX-2-specific inhibition with rofecoxib (25 mg once daily) in the treatment of patients with osteoarthritis would cause fewer gastroduodenal ulcers than an equally effective dose of ibuprofen (800 mg 3 times a day), a nonspecific COX inhibitor. METHODS: A total of 742 osteoarthritis patients without ulcers on baseline endoscopy were randomly assigned to receive rofecoxib (25 or 50 mg once daily), ibuprofen (800 mg 3 times daily), or placebo. Endoscopy was repeated at 6, 12, and 24 weeks. At 16 weeks, by study design, 95% of the placebo group and 5% of the other groups were discontinued. RESULTS: The cumulative incidence of gastroduodenal ulcers >/=3 mm with rofecoxib (25 or 50 mg once daily) was significantly (P < 0.001) lower than with ibuprofen and was statistically equivalent to placebo at week 12 (placebo, 9.9%; 25 mg rofecoxib, 4.1%; 50 mg rofecoxib, 7.3%; and ibuprofen, 27.7%). At 24 weeks, ulcer rates were 25 mg rofecoxib, 9. 6%; 50 mg rofecoxib, 14.7%; and ibuprofen, 45.8% (P < 0.001, ibuprofen vs. 25 and 50 mg rofecoxib). CONCLUSIONS: Rofecoxib, at doses 2-4 times the dose demonstrated to relieve symptoms of osteoarthritis, caused significantly less gastroduodenal ulceration than ibuprofen, with ulcer rates comparable to placebo.

Aged↗
PubMed2003

Hip disability and osteoarthritis outcome score. An extension of the Western Ontario and McMaster Universities Osteoarthritis Index.

To further develop the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC LK 3.0) for people with hip disability with or without hip osteoarthritis (OA), 52 subjects (median age 64 yrs, 35 women) answered a version of the Index with additional dimensions, twice, with a one-week interval. Reproducibility, percentage of zero scores (best possible scores), mean score of symptoms, and importance, were analyzed. This resulted in the Hip disability and osteoarthritis outcome score (HOOS LK 1.1), a 39-item questionnaire with five separate sub-scales. There were higher median scores (more symptoms) for three of HOOS sub-scales Pain, Activity limitations--sport and recreation, and Hip-related Quality of life compared to those in the WOMAC, improving the ability to assess change in patients over time. The HOOS appears to be an evaluative instrument for assessing important self-rated hip problems for people with hip disability with/without hip OA, but additional studies are needed.

Adult↗
PubMed2006

Are they relevant? A critical evaluation of the international classification of functioning, disability, and health core sets for osteoarthritis from the perspective of patients with knee osteoarthritis in Singapore.

OBJECTIVES: To determine the extent to which health items identified from the perspective of patients with knee osteoarthritis can be linked with the International Classification of Functioning, Disability and Health (ICF); and to evaluate critically the content validity of ICF comprehensive and brief core sets for osteoarthritis. METHODS: Items identified from a focus group study were linked independently by two researchers based on the 10 a priori linking rules. Both percentage agreement and kappa statistics were calculated to measure interobserver agreement. Any disagreements were resolved by reaching a consensus among the researchers. The categories linked with all items were compared with the comprehensive core set, while the categories linked with those items reported as important by over 30% of subjects within each of three local ethnic groups (Chinese, Malay, and Indian) were compared with the brief core set. Both comparisons were made only at the second level of the ICF. RESULTS: In all, 74 items were linked with 44 different ICF categories through 105 linkages with generally good interobserver agreement. The 69 items were linked with the ICF at the third or fourth levels. Both commonalities and disparities were found through comparison between the categories linked with these items and both core sets. CONCLUSIONS: All items could be successfully linked with the ICF. The comprehensive core set showed good content validity, while the brief core set needs to be supported by more empirical evidence in various sociocultural contexts. This study specifically complemented the development and refinement of both core sets from the perspective of patients with knee osteoarthritis.

Adult↗
PubMed1988

The synovial membrane in osteoarthritis: a histological study including the characterisation of the cellular infiltrate present in inflammatory osteoarthritis using monoclonal antibodies.

Inflammatory infiltration of the synovial membrane has been described in a proportion of cases of osteoarthritis (OA). Using conventional histology, lymphoid follicles, diffuse fibrosis, and perivascular fibrosis were shown to be present to a significantly greater extent and in more synovial membranes in osteoarthritis than in those cases where there was a mechanical or traumatic background to the joint disease. Calcium pyrophosphate dihydrate crystals (five patients) and detritus fragments of bone and cartilage (seven patients) were present in small numbers of the total cases of OA (38) studied. Neither of these features was related to the presence of an inflammatory infiltrate. Examination of 20 osteoarthritic synovial membranes using monoclonal antibodies showed the presence of lymphoid follicles containing T helper and T suppressor lymphocytes, B lymphocytes, and macrophages expressing HLA-DR in five cases. The T helper:suppressor ratio varied between 1:1 and 2.5:1 in these follicles. In addition, half of the OA samples, including these five cases, showed the presence of a diffuse cellular infiltrate containing T and B lymphocytes and macrophages, which were HLA-DR positive. Granulocytes were present in this diffuse infiltrate in those cases containing lymphoid follicles. The results confirm the presence of an inflammatory form of osteoarthritis but also show that the proportions of lymphoid cells are not the same as those considered to be typical of rheumatoid arthritis.

Antibodies, Monoclonal↗
PubMed2000

Evaluation of the efficacy and dose-response relationship of dexibuprofen (S(+)-ibuprofen) in patients with osteoarthritis of the hip and comparison with racemic ibuprofen using the WOMAC osteoarthritis index.

OBJECTIVE: Treatment with non-steroidal anti-inflammatory drugs is the most common pharmacological therapy of rheumatic diseases. For the symptomatic treatment of painful disorders a dose-response relationship of the NSAID should be a basic requirement, which is difficult to be proven in studies because rheumatic diseases are heterogenous in terms of clinical involvement. The aim of this double-blind randomized trial was to compare the isolated active enantiomer dexibuprofen (S(+)-ibuprofen) with the double dose of racemic ibuprofen and to show a dose-response relationship of dexibuprofen in painful osteoarthritis of the hip. METHODS: 178 patients were randomly assigned to dexibuprofen 600/1,200 mg or racemic ibuprofen 2,400 mg daily. The primary endpoint was the improvement of the WOMAC osteoarthritis index after 15 days of therapy. The analysis was by intention to treat. RESULTS: The evaluation of the WOMAC OA index showed statistically significant equivalence of dexibuprofen 400 mg t.i.d. compared with racemic ibuprofen 800 mg t.i.d. by a Mann-Whitney statistic of 0.578 and the corresponding lower bound of the 95% confidence interval of 0.498. The test for superiority of dexibuprofen was borderline significant with p = 0.055. Dexibuprofen 400 mg t.i.d. and dexibuprofen 200 mg t.i.d. showed a statistically significant dose-response relationship in improving the WOMAC OA index (p = 0.023). Patients suffered from adverse drug reactions, mainly gastrointestinal disorders, 13.34% on dexibuprofen 200 mg, 15.25% on dexibuprofen 400 mg and 16.94% on racemic ibuprofen 800 mg. CONCLUSIONS: The active enantiomer dexibuprofen (S(+)-ibuprofen) proved to be an effective non-steroidal anti-inflammatory drug with a significant dose-response relationship in patients with painful osteoarthritis of the hip. Compared with racemic ibuprofen half of the daily dose of dexibuprofen shows at least equivalent efficacy. In contrast to pharmacokinetic data, the additional administration of R(-)-ibuprofen in form of racemate does not contribute to the clinical efficacy of racemic ibuprofen.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1990

[Social impact of osteoarthritis. Risk/benefit--cost/effectiveness ratio of osteoarthritis treatments].

The development of a drug for the fundamental treatment of osteoarthritis requires that its efficacy should be proven clinically. This implies that there must be a clear definition of the evaluation criterion (slowing down in the progression of osteoarthritic lesions). Marketing of a drug depends on the efficacy/safety relationship, but any assessment of the value of a fundamental treatment for osteoarthritis goes beyond the framework of a study of its efficacy. Its usefulness can be measured in terms of scales estimating the quality of life that are related to the osteoarthritic disease. Overall criteria, such as the level of maintenance treatment, can be used in comparative, randomized, double blinds trials. Pragmatic trials seem to afford a methodology which is suited to the evaluation of usefulness and therapeutic benefit. The basis of cost/effectiveness, cost/usefulness and cost/benefit studies relies on a comparison of the cost of osteoarthritis and its treatment with the benefits brought about by such treatment.

Cost-Benefit Analysis↗
PubMed1971

Studies in osteoarthritis of the hip. 3. Congenital subluxation and osteoarthritis of the hip.

Although congenital subluxation of the hip is an important primary abnormality, upon which OA hip may later supervene, other factors may also be important in individual patients. When osteoarthritis is seen with subluxation, it probably represents congenital subluxation and not displacement of the femoral head secondary to remodelling. Osteoarthritis in these cases is usually superolateral or supermedial in type, with the major impact of the disease in the superior articular cartilage. A similar form of osteoarthritis is seen in cases where leg-length disparity exists, with or without the presence of congenital subluxation, the wear occurring on the side of the long leg. It has been suggested that bio-mechanical considerations support the contention that stress is likely to be increased in the superior area of the joint on the side of a long leg, and wear can be expected to occur here. If either anomaly may provoke the later development of OA hip, it remains to be shown which is more important when both are present in the same patient.

Adult↗
PubMed1997

[Efficacy and safety of nabumetone in the treatment of knee osteoarthritis: a comparative clinical trial versus aceclofenac. Study Group of Nabumetone for Osteoarthritis of the Knee].

BACKGROUND: Non-steroidal antiinflammatory drugs are extensively prescribed for the symptomatic treatment of osteoarthritis (OA). This study compared the efficacy and safety of nabumetone with aceclofenac in patients with active knee osteoarthritis. PATIENTS AND METHODS: Phase IV, multicentre, prospective, open-label, parallel-group, randomized, three-month treatment, clinical trial, of nabumetone (1-2 g once a day) vs aceclofenac (100 mg two times each day). The main efficacy variable was intensity of pain, evaluated on a Visual Analogic Scale (VAS). In addition: Gonarthrosis Severity Index (GSI)-baseline score > 5 and < 17-, patient and physician Global Assessment of OA Activity, patient and physician Global Assessment of OA progression were assessed. Adverse events incidence and severity were assessed. Three study visits were made on a monthly basis. The main statistical analysis was by intention to treat (ITT). RESULTS: In 12 centres 274 patients were recruited (137/group), aged 62.5 +/- 8.4 years, of whom 189 completed the trial (97 nabumetone and 92 aceclofenac). 90% were female, and 83% of the patients had both knees affected. In both groups the intensity of pain at month 3 improved significantly (p < 0.001) with respect to baseline: VAS of the nabumetone group: 6.1 +/- 1.9 to 4.3 +/- 2.8 cm; VAS of the aceclofenac group: 6.1 +/- 1.9 to 4.4 +/- 2.7 cm. There were no significant differences in any of the intergroup comparisons made. 15 nabumetone-treated and 23 aceclofenac-treated patients withdrew from the study due to moderate to severe adverse events. Gastrointestinal adverse events were the reason for withdrawal in 7 nabumetone and 14 aceclofenac-treated patients. CONCLUSIONS: The efficacy and safety of nabumetone are similar to those of aceclofenac in the treatment of knee osteoarthritis.

Aged↗
PubMed2000

Low level laser therapy (classes I, II and III) for the treatment of osteoarthritis.

BACKGROUND: Osteoarthritis (OA) affects a large proportion of the population. Low Level Laser Therapy (LLLT) is a light source that generates extremely pure light, of a single wavelength. The effect is not thermal, but rather related to photochemical reactions in the cells. LLLT was introduced as an alternative non-invasive treatment for OA about 10 years ago, but its effectiveness is still controversial. OBJECTIVES: To assess the effectiveness of LLLT in the treatment of OA. SEARCH STRATEGY: We searched MEDLINE, EMBASE, the Cochrane Musculoskeletal registry, the registry of the Rehabilitation and Related Thereapies field and the Cochrane Controlled Trials Register up to January 30, 2000. SELECTION CRITERIA: Following an a priori protocol, only controlled clinical trials of LLLT for the treatment of patients with a clinical diagnosis of OA were eligible. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and abstracted data using predetermined forms. Heterogeneity was tested with Cochran's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results were analyzed as weighted mean differences (WMD) with 95% confidence intervals (CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept (e.g. pain). Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: Five trials were included, with 112 patients randomized to laser, 85 patients to placebo laser. Treatment duration ranged from 4 to 10 weeks. Pain was assessed by four trials. The pooled estimate (random effects) of three trials showed no effect on pain measured using a scale (SMD: -0.2, 95% CI: -1.0, +0.6), but there was statistically significant heterogeneity (p>0,05). Two of the trials showed no effect and one demonstrated very beneficial effects with laser. In another trial, with no scale-based pain outcome, significantly more patients reported pain relief (yes/no) with laser with an odds ratio of 0.05, (95% CI: 0.0 to 1.56). Other outcomes of joint tenderness, joint mobility and strength were not significant. REVIEWER'S CONCLUSIONS: For OA, the results are conflicting in different studies and may depend on the method of application and other features of the LLLT application. Clinicians and researchers should consistently report the characteristics of the LLLT device and the application techniques used. New trials on LLLT should make use of standardized, validated outcomes. Despite some positive findings, this meta-analysis lacked data on how LLLT effectiveness is affected by four important factors: wavelength, treatment duration of LLLT, dosage and site of application over nerves instead of joints. There is clearly a need to investigate the effects of these factors on LLLT effectiveness for OA in randomized controlled clinical trials.

Humans↗
PubMed2003

Investigation of generalized osteoarthritis by combining X-ray grading of the knee, spine and hand using biochemical markers for arthritis in patients with knee osteoarthritis.

The aim of this study was to investigate generalized osteoarthritis (GOA) by combining X-ray grading of the knee, spine and hand using biochemical markers for arthritis, such as YKL-40 and urinary pyridinoline (Pyr). One hundred and thirty postmenopausal women with primary knee osteoarthritis (OA) aged 55-92 years were included. Knee X-rays were taken in all patients. Spinal X-rays and hand X-rays were taken in 101 and 102 patients, respectively, and both spine and hand X-rays were taken in 86 patients. The degree of OA was graded using the Kellgren-Lawrence grading scale. Blood and urine were collected from all patients. Serum YKL-40 was measured using an ELISA kit and Pyr was measured using high-performance liquid chromatography directly linked to an automated sample preparation with extraction columns system. The knee X-ray grades were most related to YKL-40 and Pyr. A combination of knee and spinal OA grades revealed a significant relation to changes in both YKL-40 and Pyr, and a combination of hand OA and knee OA grades to YKL-40. Although OA of the three joints was related to YKL-40, hand OA alone was not related to either of the biochemical markers. We concluded that Pyr and YKL-40 as biochemical markers of arthritis did not discriminate GOA defined by hand OA alone. Overall observation in the combination of three joint sites indicated that the site to discriminate GOA, from the most useful to the least, was the knee, the spine and the hand, and knee OA was the most closely related to Pyr and YKL-40.

Adipokines↗
PubMed2002

Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index.

The aim of this study was to validate a translated version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire in Spanish patients with hip or knee osteoarthritis (OA). The WOMAC questionnaire and the SF-36 were administered to a sample of 269 patients on the waiting list for hip or knee replacement. We studied the convergent validity and the item-scale correlation using Pearson's correlation coefficient and Spearman's pi. For the reliability study we used another sample of 58 patients who received the WOMAC twice within 15 days. The Pearson's, Spearman's pi, and intraclass correlation coefficients were calculated. Internal consistency was measured by Cronbach's alpha. The responsiveness study was carried out by resending the two questionnaires to all patients 6 months after surgical intervention; responsiveness was measured by means of the paired t-test, the effect size I and the standardised response mean. The Pearson's coefficients for the convergent validity ranged from -0.52 to -0.63. The coefficients obtained for the item-scale correlation of the pain area were 0.74 or higher, 0.91 or higher for stiffness, and 0.61 or higher for function. When measuring the test-retest reliability, the coefficients ranged from 0.66 to 0.81. Internal consistency yielded a Cronbach's alpha ranging from 0.81 to 0.93. The responsiveness showed an effect size I ranging from 1.5 to 2.2 in patients who underwent hip replacement; for those who underwent knee replacement the range was 1 to 1.8. The standardised response mean ranged from 1.3 to 1.9 for patients with hip OA; those with knee OA ranged from 0.8 to 1.5. The Spanish version of WOMAC is a valid, reliable and responsive instrument in patients with hip or knee OA.

Aged↗
PubMed2005

The association of radiographic foot osteoarthritis and radiographic osteoarthritis at other sites.

OBJECTIVE: To quantify the association between radiographic foot osteoarthritis (OA) and radiographic OA at four joints: second distal interphalangeal (DIP), third proximal interphalangeal (PIP), first carpometacarpal (CMC), and the knee. METHODS: Data collected for the Clearwater Osteoarthritis Study (COS) were analyzed (N=3436). The study outcome was first metatarso-phalangeal joint (first MTP) OA status. The predictor variables were second DIP, third PIP, first CMC, and knee OA. The Kellgren and Lawrence scale determined OA status. The strength of the association between foot OA and other sites was further explored by unilateral and bilateral categories. RESULTS: For both genders, we found a significant, positive relationship between grade 2+ foot OA and second DIP, third PIP, first CMC, and knee OA. This relationship maintained its significance after adjustment for age, body mass index, and occupational history. Adjusted odds ratios ranged from 3.2 for the second DIP joint (P<0.0001) to 3.7 for the knee joint (P<0.0001). Relative to unilateral joint disease, co-existing bilateral disease yielded a significantly elevated risk for foot OA for all joints examined. While other studies have not specifically examined co-occurrence with foot OA, our findings are consistent with results from related studies. CONCLUSIONS: There is a dearth of studies exploring foot OA. Our findings support the theory of a systemic etiology involved in the development of OA. Future epidemiological studies that further distinguish the relationship between OA at differing sites will provide an enhanced ability to describe the respective influences of mechanical and systemic factors in the development of this disease.

Adult↗
PubMed2000

Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative.

BACKGROUND: The domains of pain, function and patient's global assessment are identified as core variables and frequently measured in clinical trials of patients with osteoarthritis (OA) of the hip and knee. OBJECTIVE: To develop response criteria for OA of hip and knee based on the domains of pain, function and patient's global assessment. METHODS: A methodology was developed by an interaction of the Osteoarthritis Research Society International Standing Committee on Clinical Trials, biostatisticians, pharmaceutical company representatives and health agency representatives. Data from previously conducted placebo-controlled clinical trials were normalized and collated. Data were subset by location of OA (knee, hip), active agent used in the clinical trial (non-steroidal anti-inflammatory drug, other agent) and route of administration (oral, intra-articular). Statistical analysis identified response criteria which best discriminate active agent from placebo. RESULTS: Based on the analysis of data from 14 studies (totaling 1886 patients) and consensus opinion, the optimal responder criteria set differed for location of OA, active agent to be used, and route of administration. Because of nearly identical statistical results, two sets of responder criteria are proposed: (1) 'high' pain response or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment; (2) 'high' response for either pain or function or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment. The sensitivity (i.e., the percentage of responders in the active group) ranged from 52 to 96% and the specificity (i.e., the percentage of nonresponders in the control group) from 47 to 73%. CONCLUSION: Based on data from clinical trials, two sets of responder criteria have been developed that can categorize an individual's responses to treatment in a clinical trial. These responder criteria require validation in additional datasets.

Aged↗
PubMed2001

Validation of the Western Ontario and Mcmaster University osteoarthritis index in Asians with osteoarthritis in Singapore.

OBJECTIVE: To assess the reliability and validity of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) as an outcome measure in Asian patients with knee or hip osteoarthritis (OA) in Singapore. DESIGN: The WOMAC was administered twice 7 days apart to 66 consecutive English-speaking Chinese, Malay or Indian inpatients and outpatients with knee or hip OA seen at a tertiary referral centre through a structured interview, which also assessed demographic and other characteristics. Internal consistency was assessed using Cronbach's alpha, reliability using Spearman's correlations, intraclass correlations and repeatability coefficients, and relationships between WOMAC domains and known determinants of function using Spearman's correlations and the Mann-Whitney U-test. RESULTS: The WOMAC showed good internal consistency (alpha=0.70 to 0.93) and good reliability, with intraclass correlations of 0.83 to 0.90 and mean test-retest score differences of 0.02 to 0.13 points (possible range 4 points). Results of Likert scoring assessment supported the validity of the WOMAC when interpreted in the context of the close association between pain and physical function. Eight of nine a priori hypotheses relating WOMAC Pain and Physical Function scores to known determinants of function were present, supporting construct validity of this scale. CONCLUSION: The WOMAC is a valid and reliable outcome measure in Asian patients with OA in Singapore.

Adult↗
PubMed2003

Smoking and osteoarthritis: is there an association? The Clearwater Osteoarthritis Study.

OBJECTIVE: To evaluate the association between cigarette smoking and the subsequent development of osteoarthritis (OA) at four separate sites: knee, hand, foot and cervical spine. METHODS: This cohort study examined 2505 men and women aged 40 years and older participating in the longitudinal Clearwater Osteoarthritis Study (1988-current). Biennial physical exams, including serial radiographs, as well as historical information, were collected. The Lawrence and Kellgren ordinal scale was used to determine radiological evidence of the study outcome, OA. Self-reported history of smoking behavior was used to determine the study exposure. Smoking was classified using four approaches: (1) ever/never, (2) former/never, (3) current/never, and (4) dose. RESULTS: Among the individuals at study entry, radiologically confirmed incident OA was detected during the follow-up period at four sites: knee (32%), hand (49%), foot (28%), and cervical spine (52%). Approximately 11% were self-reported current smokers. Unadjusted analyses indicated that individuals classified as current smokers demonstrated significant levels of protection from OA at all four sites investigated. However, adjusted point estimates ranging from 0.60-1.48 were suggestive of no association between smoking and the development of OA at any of the four sites investigated. CONCLUSION: Based upon the findings of this prospective study, smoking does not appear to convey a clinically significant level of protection against the development of radiologically-confirmed OA. While these findings corroborate previous studies indicating no association between smoking and OA, anecdotal evidence warrants investigation into the role that cigarette smoking may play in the symptomatology of OA.

Cohort Studies↗