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M Lequesne

Publications and source records attributed to M Lequesne.

At least 37 records · Page 2Linked to original sources
PubMed1997

Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.

Significant progress has been made in outcome measurement procedures for osteoarthritis (OA) clinical trials, and guidelines have been established by the US Food and Drug Administration, European League Against Rheumatism, the World Health Organization/International League of Associations for Rheumatology, and the Group for the Respect of Ethics and Excellence in Science. However, there remains a need for further international harmonization of measurement procedures used to establish beneficial effects in Phase III clinical trials. A key objective of the OMERACT III conference was to establish a core set of outcome measures for future phase III clinical trials. During the conference, using a combination of discussion and polling procedures, a consensus was reached by at least 90% of participants that the following 4 domains should be evaluated in future phase III trials of knee, hip, and hand OA: pain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging (using standardized methods for taking and rating radiographs, or any demonstrably superior imaging technique). These evidence based preferences, achieved with a high degree of consensus, establish an international standard for future phase III trials and will also facilitate metaanalysis and Cochrane Collaborative Project goals.

Clinical Trials, Phase III as Topic↗
PubMed1997

Floctafenin versus acetaminophen for pain control in patients with osteoarthritis in the lower limbs. Franco-Belgian Task Force.

A multicenter, double-blind, cross-over, random-order study compared the efficacy of floctafenin, 800 mg/day and acetaminophen, 3000 mg/day, in providing pain relief to 192 patients with chronic pain due to osteoarthritis in the lower limbs. Each drug was given for 12 days and the interval between the two treatment periods was two days. The primary evaluation criterion was pain relief as assessed using the visual analog scale developed by Huskisson (mean baseline score, 62.7 +/- 13.6 mm). Secondary criteria were the algofunctional index, the investigator's overall efficacy rating and patient preference. Floctafenin therapy was associated with significantly better results regarding the visual analog scale score (P = 0.036, 149 patients in the per protocol analysis) and the investigator's overall efficacy rating (P = 0.0001, 169 evaluable patients). Among the 169 evaluable patients, 68 had no preference for either treatment and 101 had a preference, which was for floctafenin therapy in 65% of cases (P = 0.001). Clinical tolerance was satisfactory with both drugs. Gastrointestinal symptoms were the most common side effects (13% and 11% of patients with floctafenin and acetaminophen, respectively).

Acetaminophen↗
PubMed1997

Radiographic features predictive of radiographic progression of hip osteoarthritis.

OBJECTIVES: To evaluate potential radiographic predictors of hip osteoarthritis progression. PATIENTS AND METHODS: A prospective, longitudinal two-year study was conducted in patients meeting American College of Rheumatology criteria for hip osteoarthritis. Hip osteoarthritis progression was defined as a greater than 0.5-mm decrease in joint space width measured using a magnifying glass marked at intervals of 0.1 mm, at the site of maximum joint space narrowing, by a single investigator who was blinded to the chronological order of the radiographs. Radiographic parameters determined at study entry were as follows: presence of osteophytes, osteosclerosis, and subchondral cysts; femoral head migration (superolateral, superomedial, concentric); and severity (joint space width in mm, Kellgren and Lawrence grade, subjective evaluation of joint space narrowing). RESULTS: In the 463 study patients, joint space width decreased from 2.2 +/- 0.8 at baseline to 1.7 +/- 1.0 mm after two years (P < 0.0001). Radiographic progression was seen in 148 patients (32%). Radiologic parameters predictive of disease progression in the multivariate analyses were as follows: CONCLUSION: Our data suggest that a number of baseline radiological features including distribution of joint space loss, subchondral bone production, and severity of joint space loss are predictive of progression of hip osteoarthritis.

Aged↗
PubMed1996

Radiological progression of hip osteoarthritis: definition, risk factors and correlations with clinical status.

OBJECTIVES: To determine a cut off value for changes in radiological joint space width that allowed definition of radiological progression of hip osteoarthritis not related to measurement method errors and, thereafter, to determine factors predictive of radiological progression of hip osteoarthritis and to evaluate the correlations between clinical and radiological parameters. METHODS: A prospective, longitudinal (one year duration), multicentre study was made of patients with osteoarthritis of the hip (American College of Rheumatology criteria). Data on clinical activity (pain, functional impairment), demographic data (age, gender, body mass index), and femoral head migration (superolateral, superomedial, concentric) were collected when the patient entered the study; radiological grade (joint space width in millimetres at the narrowest point using a 0.1 mm graduated magnifying glass, evaluated by a single observer unaware of the chronology of the films) was recorded at the patient's entry to the study and after one year. RESULTS: Analysis of the means of the differences between two analyses performed by a single observer of 30 pairs of radiographs (one performed after an interval of one year) (0.06 (SD 0.23)) suggested that a change of more than 0.56 mm (2 SD) after a one year follow up could define progression of osteoarthritis of the hip. Of the 508 patients recruited, 461 (91%) completed the one year follow up and radiological progression was observed in 102 (22%). The factors predictive of radiological progression that were identified in the multivariate analysis were: radiological joint space width at entry < or = 2 mm, superolateral migration of the femoral head, female gender, Lequesne's functional index > 10, age at entry > 65 years (odds ratios 2.11, 4.25, 2.51, 2.66, 1.90, respectively). The level of clinical parameters (pain, functional impairment) and the amount of symptomatic treatment required (non-steroidal anti-inflammatory drugs and analgesic intake) accounted for 20% (p < 0.0001) of the variability of the changes in radiological joint space width over the one year study period. CONCLUSION: These data suggest that radiological progression of hip osteoarthritis could be defined by a change in joint space width of at least 0.6 mm after a one year follow up period, is correlated with the changes in clinical status of the patients, and is related not only to demographic data (age, gender), but also to some specific characteristics of osteoarthritis (localisation, radiological severity, clinical activity).

Aged↗
PubMed1995

Methodology of clinical trials in hand osteoarthritis. Issues and proposals.

Although very common, hand osteoarthritis has rarely been the focus of clinical trials aimed at determining whether old or new drugs are effective on its symptoms or anatomical course. In addition to the difficulties inherent to studies of osteoarthritis in general, the highly unpredictable course of hand osteoarthritis poses specific challenges. Hand osteoarthritis is only beginning to be considered a potentially useful model for therapeutic trials and clinical research, in addition to the two widely-used models, knee and hip osteoarthritis. Recent studies have provided new information on the clinical and roentgenographic course of hand osteoarthritis. An algofunctional index and a quantitative roentgenographic score have been developed and validated as tools for evaluating and monitoring hand osteoarthritis. These tools are now available for use during therapeutic trials. In this article, we will make a number of recommendations about the selection of patients and of quantitative evaluation methods. These recommendations take into account the specific features of hand osteoarthritis and of the various categories of drugs for osteoarthritis; they place special emphasis on the most recent drug classes, namely symptomatic slow-acting drugs for osteoarthritis and potentially "chondroprotective" agents.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1995

Atlas of individual radiographic features in osteoarthritis.

Radiographs of the hand, hip and knee were screened for evidence of osteoarthritis (OA). Specific sites selected for screening on the postero-anterior radiographs of the hand included the base of the thumb with distal and proximal interphalangeal joints; these regions were examined for formation of marginal osteophytes, joint space narrowing and subchondral lucency. Sites selected from antero-posterior radiographs of the hip included the acetabular and femoral portions of the joint; these regions were examined for joint space narrowing, subchondral lucency, marginal osteophytes and subchondral sclerosis. Sites selected from antero-posterior weight-bearing radiographs of the knee included distal femora and proximal tibiae including the medial and lateral compartments; these regions were examined for joint space narrowing, marginal osteophytes and subchondral sclerosis. Sites selected from axial views of the patellofemoral joint examined the medial and lateral portions; these regions were examined for joint space narrowing, osteophytes, subluxations and subchondral sclerosis. A set of photographic prints was made from the collection of radiographs. These specific features of OA were graded on each print and a subset of prints was selected that best demonstrated the spectrum of severity for each feature of OA. This resultant atlas is offered as an updated guide to standardize interpretation of radiographs prior to and during clinical trials.

Cartilage, Articular↗
PubMed1994

[Methods for evaluating chondroprotective agents].

A number of compounds have "chondroprotective" effects in animals or chondrocyte cultures. However, in humans, these drugs have not been convincingly shown to prevent, delay, arrest, or repair structural cartilage lesions due to osteoarthritis. In clinical trials, the main evaluation criterion should be the time-course of cartilage lesions. One parameter for assessing cartilage lesions is cartilage thickness, which can be measured at the site of greatest joint space loss using compasses and a magnifying glass. Alternatively, joint space surface area in the abnormal zone can be determined by automatic analysis of digitalized images. Use of echotomographic sections obtained using an intraarticular probe inserted during arthroscopy of the knee has been advocated. External measurements by magnetic resonance imaging or ultrasonography are technically difficult and most have been found inadequate during validation studies. Clinical trials should also include a clinical assessment of therapeutic benefits, without which chondroprotection would be pointless. Duration of these trials should be two to four years, since cartilage loss occurs slowly in osteoarthritis: mean values of 1/4 mm per year, with wide variations, have been reported at the hip and knee. A randomized, double-blind, placebo-controlled design should be used.

Cartilage Diseases↗
PubMed1994

Guidelines for testing slow acting drugs in osteoarthritis.

New compounds appear to improve symptoms of osteoarthritis (OA), and others are putative chondroprotective agents. We suggest experimental designs for studying the effects of these agents in subjects with hip and knee OA. The course of the articular cartilage lesion is the primary outcome measure to be assessed in putative chondroprotective agent trials. Serial radiographic studies suggest that the annual rate of joint space narrowing in patients with hip or knee OA is about 0.25 mm. Other approaches to quantitation of cartilage loss, e.g., radiographic measurement of the area of joint space, ultrasonography, magnetic resonance imaging and fiberoptic arthroscopy (for knee OA) are under investigation.

Antirheumatic Agents↗
PubMed1994

[Pigmented villonodular synovitis of the hip. Results of a national survey apropos of 58 cases].

Pigmented villonodular synovitis is an uncommon synovial disease which only rarely involves the hip. In a multicenter retrospective study, we identified 58 histologically-proven cases. There were 33 females and 25 males. Mean age at diagnosis was 38 years. In all but two cases, only one hip was involved; the right hip was affected somewhat more often (33 cases) than the left. Two patients probably had bilateral hip disease. Mean delay to diagnosis was four years. Pain was the presenting symptom in most cases. A palpable mass in the groin was found in six patients. Plain roentgenograms were considered normal in only three patients. Bony cysts were seen in 39 patients and kissing cysts in 19. Joint space narrowing was found in 40 patients and was diffuse in half the cases. Roentgenograms suggested pigmented villonodular synovitis in 63% of cases, osteoarthritis of the hip in 16%, and inflammatory hip disease in 14%. Additional imaging studies included opaque arthrography in 21 subjects, computed tomography in 23, magnetic resonance imaging in 11, and arthroscopy in 9. Initial treatment was osmic acid synoviorthesis in 14 patients, partial synovectomy in 9, and total synovectomy in 21; in addition, eight patients had insertion of a cup prosthesis and 13 had total arthroplasty of the hip. Treatment was successful in 65% of cases after a mean follow-up of three years; among the 35% of failures, there were seven recurrences (14%). Total hip arthroplasty was performed secondarily in nine patients. This study illustrates the diversity of roentgenological changes in pigmented villonodular synovitis of the hip and the high frequency of osteoarticular lesions precluding conservative treatment. Magnetic resonance imaging and/or arthroscopy should be used to establish the diagnosis at an early stage when conservative treatment with total synovectomy and synoviorthesis is most likely to be successful.

Adolescent↗