Joint unloading implant modifies subchondral bone trabecular structure in medial knee osteoarthritis: 2-year outcomes of a pilot study using fractal signature analysis.

Miller, Larry E.; Sode, Miki; Fuerst, Thomas; Block, Jon E.

doi:10.2147/CIA.S76982

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Joint unloading implant modifies subchondral bone trabecular structure in medial knee osteoarthritis: 2-year outcomes of a pilot study using fractal signature analysis.

Author(s): Larry E Miller ¹ , Miki Sode ² , Thomas Fuerst ² , Jon E Block ³

Publication date (Electronic): 2015

Journal: Clinical interventions in aging

Publisher: Informa UK Limited

Keywords: KineSpring, disease modification, joint space, pain, trabecular

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Abstract

Knee osteoarthritis (OA) is largely attributable to chronic excessive and aberrant joint loading. The purpose of this pilot study was to quantify radiographic changes in subchondral bone after treatment with a minimally invasive joint unloading implant (KineSpring(®) Knee Implant System).

Most cited references 25

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Analysis of serial measurements in medical research.

J. Matthews, D Altman, M. J. Campbell … (1990)

In medical research data are often collected serially on subjects. The statistical analysis of such data is often inadequate in two ways: it may fail to settle clinically relevant questions and it may be statistically invalid. A commonly used method which compares groups at a series of time points, possibly with t tests, is flawed on both counts. There may, however, be a remedy, which takes the form of a two stage method that uses summary measures. In the first stage a suitable summary of the response in an individual, such as a rate of change or an area under a curve, is identified and calculated for each subject. In the second stage these summary measures are analysed by simple statistical techniques as though they were raw data. The method is statistically valid and likely to be more relevant to the study questions. If this method is borne in mind when the experiment is being planned it should promote studies with enough subjects and sufficient observations at critical times to enable useful conclusions to be drawn. Use of summary measures to analyse serial measurements, though not new, is potentially a useful and simple tool in medical research.

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The statistical interpretation of pilot trials: should significance thresholds be reconsidered?

Ellen Lee, Amy Whitehead, Richard M Jacques … (2014)

Background In an evaluation of a new health technology, a pilot trial may be undertaken prior to a trial that makes a definitive assessment of benefit. The objective of pilot studies is to provide sufficient evidence that a larger definitive trial can be undertaken and, at times, to provide a preliminary assessment of benefit. Methods We describe significance thresholds, confidence intervals and surrogate markers in the context of pilot studies and how Bayesian methods can be used in pilot trials. We use a worked example to illustrate the issues raised. Results We show how significance levels other than the traditional 5% should be considered to provide preliminary evidence for efficacy and how estimation and confidence intervals should be the focus to provide an estimated range of possible treatment effects. We also illustrate how Bayesian methods could also assist in the early assessment of a health technology. Conclusions We recommend that in pilot trials the focus should be on descriptive statistics and estimation, using confidence intervals, rather than formal hypothesis testing and that confidence intervals other than 95% confidence intervals, such as 85% or 75%, be used for the estimation. The confidence interval should then be interpreted with regards to the minimum clinically important difference. We also recommend that Bayesian methods be used to assist in the interpretation of pilot trials. Surrogate endpoints can also be used in pilot trials but they must reliably predict the overall effect on the clinical outcome.

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Role of subchondral bone in the initiation and progression of cartilage damage.

Hugh Rose, E L Radin (1986)

Osteoarthrosis is a physiologic imbalance, a "joint failure" similar to "heart failure," in which mechanical factors play a role. The initiation and progression of cartilage damage are distinct phenomena. One of the mechanisms of initiation may be a steep stiffness gradient in the underlying subchondral bone. Progression of cartilage lesions probably requires stiffened subchondral bone. In such situations, transverse stresses at the base of the articular cartilage could cause deep horizontal splits in that tissue. The most likely cause of subchondral stiffening in an otherwise congruent joint is repeated failure of the musculoskeletal peak dynamic force attenuation mechanisms. The health and integrity of the overlying articular cartilage depends on the mechanical properties of its bony bed. In certain models of osteoarthrosis, alterations of the bony bed occur before the cartilage changes and suggest that this can occur in clinical conditions. Stiffening of the subchondral bone also can effect joint conformation, which involves deformation of articular cartilage and bone to create maximum contact areas under load.