Risk factors predictive of joint replacement in a 2-year multicentre clinical trial in knee osteoarthritis using MRI: results from over 6 years of observation.

Abstract

OBJECTIVE:

To identify predictive factors for total knee replacement (TKR) using data from MRI of knee osteoarthritis patients in a phase III multicentre disease-modifying osteoarthritis drug (DMOAD) study.

METHODS:

Knee osteoarthritis patients from a 2-year clinical trial evaluating licofelone versus naproxen were investigated for the incidence of TKR of the study knee. Patients (n=161) who completed the study according to protocol were selected. Incidence of TKR was assessed blindly to the treatment following telephone interviews (n=123).

RESULTS:

18 TKR (14.6%) were performed in 4-7 years following enrolment in the original study. More TKR were performed within the naproxen than the licofelone group (61% vs 39%, p=0.232). Baseline score of bone marrow lesions (BML) in the medial compartment (p=0.0001), medial joint space width (JSW) as assessed by standardised radiographs (p=0.0008), presence of severe medial meniscal tear (p=0.004), medial meniscal extrusion (p=0.013), and C-reactive protein level (p=0.049) were strong predictors of TKR. Changes at the end of the study also yielded strong predictors: change in cartilage volume of the medial compartment (p=0.005) and of the global knee (p=0.034), reduction in the JSW of greater than 7% (p=0.009), and WOMAC pain (p=0.009) and function (p=0.023) scores. Multivariate analysis showed that baseline severe medial meniscal tear (p=0.023) and presence of medial BML (p=0.025) were the strongest independent long-term predictors of TKR.

CONCLUSION:

This study shows that in the context of osteoarthritis trials, clinical data and structural changes identified by MRI allow prediction of a 'hard' outcome such as TKR. The findings support the usefulness and predictive value of MRI in defining study outcome in DMOAD trials.

• Authors: Jean-Pierre Raynauld, Johanne Martel-Pelletier, Boulos Haraoui, Denis Choquette, Marc Dorais, Lukas M Wildi, François Abram, Jean-Pierre Pelletier, Canadian Licofelone Study Group
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 70 Issue 8 Pg. 1382-8 (Aug 2011) ISSN: 1468-2060 [Electronic] England
• PMID: 21551506 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Pyrroles
• Naproxen
• C-Reactive Protein
• licofelone

Topics

• Aged
• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Arthroplasty, Replacement, Knee
• C-Reactive Protein (metabolism)
• Disease Progression
• Epidemiologic Methods
• Female
• Humans
• Knee Joint (pathology)
• Magnetic Resonance Imaging (methods)
• Male
• Menisci, Tibial (pathology)
• Middle Aged
• Naproxen (therapeutic use)
• Osteoarthritis, Knee (drug therapy, pathology, surgery)
• Prognosis
• Pyrroles (therapeutic use)
• Tibial Meniscus Injuries