Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis

Roy D Altman, E. Abadie, B. Avouac, G. Bouvenot, J. Branco, O. Bruyere, G. Calvo, J. P. Devogelaer, R. L. Dreiser, G. Herrero-Beaumont, A. Kahan, G. Kreutz, A. Laslop, E. M. Lemmel, C. J. Menkes, K. Pavelka, L. Van De Putte, L. Vanhaelst, J. Y. Reginster, Francois BailleulWillard Dere, Dominique Ethgen, Eleonora Tajana Messi, Bruce Mitlak, John Orloff, Carole Robin, Lucio Rovati, Yannis Tsouderos, Philippe Van de Auwera

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents. Methods: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting. Results: There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30%. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (>90%), that remains after controlling for OA pain severity. Conclusion: At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of >90% for not having surgery. GREES suggests utilizing joint space narrowing (e.g., >0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., ≥ 20-25%) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee.

Original languageEnglish (US)
Pages (from-to)13-19
Number of pages7
JournalOsteoarthritis and Cartilage
Volume13
Issue number1
DOIs
StatePublished - Jan 2005
Externally publishedYes

Fingerprint

Replacement Arthroplasties
Osteoarthritis
Surgery
Hip
Knee
Outcome Assessment (Health Care)
Joints
Ethics
Hip Osteoarthritis
Knee Osteoarthritis
Structure Collapse
Manuscripts
PubMed
Guidelines
Sensitivity and Specificity
Pain

Keywords

  • Disease modification
  • GREES
  • Joint replacement surgery
  • Joint space narrowing
  • Randomized clinical trials
  • Structure modifying trials for osteoarthritis

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine

Cite this

Altman, R. D., Abadie, E., Avouac, B., Bouvenot, G., Branco, J., Bruyere, O., ... Van de Auwera, P. (2005). Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis. Osteoarthritis and Cartilage, 13(1), 13-19. https://doi.org/10.1016/j.joca.2004.10.012

Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis. / Altman, Roy D; Abadie, E.; Avouac, B.; Bouvenot, G.; Branco, J.; Bruyere, O.; Calvo, G.; Devogelaer, J. P.; Dreiser, R. L.; Herrero-Beaumont, G.; Kahan, A.; Kreutz, G.; Laslop, A.; Lemmel, E. M.; Menkes, C. J.; Pavelka, K.; Van De Putte, L.; Vanhaelst, L.; Reginster, J. Y.; Bailleul, Francois; Dere, Willard; Ethgen, Dominique; Tajana Messi, Eleonora; Mitlak, Bruce; Orloff, John; Robin, Carole; Rovati, Lucio; Tsouderos, Yannis; Van de Auwera, Philippe.

In: Osteoarthritis and Cartilage, Vol. 13, No. 1, 01.2005, p. 13-19.

Research output: Contribution to journalArticle

Altman, RD, Abadie, E, Avouac, B, Bouvenot, G, Branco, J, Bruyere, O, Calvo, G, Devogelaer, JP, Dreiser, RL, Herrero-Beaumont, G, Kahan, A, Kreutz, G, Laslop, A, Lemmel, EM, Menkes, CJ, Pavelka, K, Van De Putte, L, Vanhaelst, L, Reginster, JY, Bailleul, F, Dere, W, Ethgen, D, Tajana Messi, E, Mitlak, B, Orloff, J, Robin, C, Rovati, L, Tsouderos, Y & Van de Auwera, P 2005, 'Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis', Osteoarthritis and Cartilage, vol. 13, no. 1, pp. 13-19. https://doi.org/10.1016/j.joca.2004.10.012
Altman, Roy D ; Abadie, E. ; Avouac, B. ; Bouvenot, G. ; Branco, J. ; Bruyere, O. ; Calvo, G. ; Devogelaer, J. P. ; Dreiser, R. L. ; Herrero-Beaumont, G. ; Kahan, A. ; Kreutz, G. ; Laslop, A. ; Lemmel, E. M. ; Menkes, C. J. ; Pavelka, K. ; Van De Putte, L. ; Vanhaelst, L. ; Reginster, J. Y. ; Bailleul, Francois ; Dere, Willard ; Ethgen, Dominique ; Tajana Messi, Eleonora ; Mitlak, Bruce ; Orloff, John ; Robin, Carole ; Rovati, Lucio ; Tsouderos, Yannis ; Van de Auwera, Philippe. / Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis. In: Osteoarthritis and Cartilage. 2005 ; Vol. 13, No. 1. pp. 13-19.
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abstract = "Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents. Methods: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting. Results: There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30{\%}. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (>90{\%}), that remains after controlling for OA pain severity. Conclusion: At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of >90{\%} for not having surgery. GREES suggests utilizing joint space narrowing (e.g., >0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., ≥ 20-25{\%}) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee.",
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AU - Branco, J.

AU - Bruyere, O.

AU - Calvo, G.

AU - Devogelaer, J. P.

AU - Dreiser, R. L.

AU - Herrero-Beaumont, G.

AU - Kahan, A.

AU - Kreutz, G.

AU - Laslop, A.

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AU - Reginster, J. Y.

AU - Bailleul, Francois

AU - Dere, Willard

AU - Ethgen, Dominique

AU - Tajana Messi, Eleonora

AU - Mitlak, Bruce

AU - Orloff, John

AU - Robin, Carole

AU - Rovati, Lucio

AU - Tsouderos, Yannis

AU - Van de Auwera, Philippe

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