Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The purpose of this study was to see if incorporating the BioniCare device into an unloading brace would produce more rapid improvement, greater compliance and therefore greater effectiveness
Methods: 289 patients who were treated with BioniCare alone served as historical controls and were compared with 225 patients treated with BioniCare combined with VQ’s OActive unloading brace. A generalized linear model repeated measures analysis of change from baseline was performed, with sex, age, treatment (BioniCare in knee OActive unloading brace versus BioniCare alone), cumulative device use at each month of follow-up (1, 3, 6 and 12 months), and baseline score as predictors of the model.
Results: It was demonstrated that BioniCare combined with the OActive unloading brace was superior to BioniCare alone. Except for Sleep Pain, and Physicians Global Assessment which trended toward statistical significance, there was statistically significant superiority of BioniCare treatment combined with an unloading brace as compared to BioniCare alone. (Table I) With the exception of the one month evaluation of pain while sleeping at night, all seven outcome measures were superior with BioniCare combined in the OActive unloading brace as compared to BioniCare alone at 1,3,6 and 12 months of treatment. After three months of treatment both groups had a moderate effect size in all outcome parameters. As can be seen in the illustrative figures, the patient global assessment, patient pain on walking up and down stairs, and the physician global assessment had a large effect size (>1.0) at one year in the BioniCare combined with the unloading brace group. (Figures 1, 2) In the combined group, the effect size approached 1.0 with pain on walking on a flat surface (figure 2).
Conclusion: There is an additive benefit of combining an unloading brace with BioniCare device treatment and the advantage of this combination continued throughout the study and was apparent even after one year of treatment.
|
Efficacy End-point |
Estimate Treatment Difference |
Std Err |
Chi-Square Test |
p-value |
|
48 hr. OA Pain |
0.2060 |
0.0527 |
15.28 |
<.0001 |
|
MD Global Assessment |
0.0927 |
0.0532 |
3.04 |
0.0814 |
|
OA Pain |
0.1864 |
0.0516 |
13.07 |
0.0003 |
|
PT Global Assessment |
0.2066 |
0.0543 |
14.48 |
0.0001 |
|
Sleep Pain |
0.0295 |
0.0553 |
0.29 |
0.5933 |
|
Up/Down Stairs |
0.2684 |
0.0582 |
21.29 |
<.0001 |
|
Walking Pain |
0.2119 |
0.0536 |
15.65 |
<.0001 |
|
NOTE: Treatment effect as estimated from a generalized linear model of repeated measures |
||||
Treatment of osteoarthritis of the knee with BioniCare in an OActive unloading brace is significantly superior to BioniCare alone.
FIG 1: Change From Baseline Time Physician and Patient Global
FIG 2: Change From Baseline Time Walking Pain and Stair Pain
Disclosure:
T. Zizic,
VQ OrthoCare,
5;
D. S. Hungerford,
None;
E. J. MacLaughlin,
None;
C. Mines,
None;
S. Deveshwar,
None;
T. L. Ford,
None;
C. Elliott,
None;
J. R. Principe,
None;
J. S. Tuber,
None;
J. Schechtman,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/synergistic-effect-of-combining-bionicare-in-an-unloading-brace-for-osteoarthritis-of-the-knee/