Summary of findings for the main comparison. Braces and orthoses for varus medial osteoarthritis of the knee.
| Valgus knee braces and orthoses for varus medial osteoarthritis of the knee | ||||||
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Patient or population: patients with varus medial osteoarthritis of the knee Settings: general hospital Intervention: valgus knee brace or lateral wedge insole Comparison: no brace or neutral insole | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Intervention | |||||
| Valgus knee brace compared with no brace | ||||||
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Pain on walking (VAS) Scale from 0 to 10 Follow‐up: 12 months (Higher score is worse) |
Mean pain score in control groups was 5.2 |
Mean pain in intervention groups was equal (0.84 lower to 0.84 higher) | 115 (1 study) |
⊕⊕⊝⊝ Lowa,b | MD = 0.00 (95% CI ‐0.84 to 0.84) Absolute percent change = 0% (95% CI ‐8.4 to 8.4) Relative percent change = 0% (95% CI ‐1.6 to 1.6) NNTB = not statistically significant |
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Knee function (HSS) Scale from 0 to 100 Follow‐up: 12 months (Higher score is better) |
Mean function score in control groups was 69 | Mean function in intervention groups was 1.00 higher (2.98 lower to 4.98 higher) |
110 (1 study) |
⊕⊕⊝⊝ Lowa,b | MD = 1.00 (95% CI ‐2.98 to 4.98) Absolute percent change = 1.0% (95% CI 3.0 to 5.0) Relative percent change = 0.01% (95% CI 0.05 to 0.07) NNTB = not statistically significant |
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Quality of life (EQ‐5D) Scale from 0 to 100 Follow‐up: 12 months (Higher score is better) |
Mean health‐related quality of life score in control groups was 0.6 | Mean health‐related quality of life score in intervention groups was 0.04 lower (0.12 lower to 0.04 higher) | 117 (1 study) |
⊕⊕⊝⊝ Lowa,b | MD = 0.04 (95% CI ‐0.12 to 0.04) Absolute percent change = 0.04% (95% CI ‐0.12 to 0.04) Relative percent change = 0.07% (95% CI ‐0.2 to 0.07) NNTB = not statistically significant |
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Total number of adverse events (withdrawals due to lack of effect)c Follow‐up: 12 months |
Low‐risk population | RR 1.63 (0.94 to 2.82) | 117 (1 study) |
⊕⊕⊝⊝ Lowa,b | Absolute percent change = 15% (95% CI ‐1% to 32%) Relative percent change = 63% (95% CI ‐6% to 182%) NNTB = not statistically significant |
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| 246 per 1000 | 400 per 1000 (239 to 694) | |||||
| Lateral‐wedge insole compared with neutral insole | ||||||
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Pain on walking (NRS) Scale from 0 to 10 Follow‐up: mean 12 months (Higher score is worse) |
Mean pain on walking score in control groups was 2.6 | Mean pain on walking in intervention groups was 0.1 higher (0.45 higher to 0.65 lower) |
224 (2 studies) |
⊕⊕⊕⊝ Moderatea | MD = 0.10 (95% CI ‐0.45 to 0.65) Absolute percent change = 1.0% (95% CI 4.5 to ‐6.5) Relative percent change = 3.8% (95% CI 1.7 to ‐25.0) NNTB = not statistically significant |
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Physical function (WOMAC) ‐
12 months Scale from 0 to 100 Follow‐up: mean 12 months (Higher score is better) |
Mean function score in control groups was 36.6 | Mean function in intervention groups was 0.94 higher (2.98 lower to 4.87 higher) | 358 (3 studies) |
⊕⊕⊕⊝ Moderatea | MD = 0.94 (95% CI ‐2.98 to 4.87) Absolute percent change = 0.9% (95% CI ‐3.0 to 4.9) Relative percent change = 2.6% (95% CI ‐8.1 to 13.3) NNTB = not statistically significant |
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Health‐related quality of life (HRQoL) Scale from 0 to 1.0 Follow‐up: 12 months (Higher score is better) |
Mean health‐related quality of life score in control groups was 0.7 |
Mean health‐related quality of life score in intervention groups was 0.01 lower (0.05 lower to 0.03 higher) |
179 (1 study) |
⊕⊕⊕⊝ Moderatea | MD = 0.00 (95% CI ‐0.06 to 0.06) Absolute percent change = 1.0% (95% CI ‐5.0 to 3.0) Relative percent change = 1.4% (95% CI ‐7.1 to 4.3) NNTB = not statistically significant |
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| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; EQ‐5D: EuroQol‐5D; HSS: Hospital for Special Surgery knee score; NNTB: number needed to treat for an additional beneficial outcome; NRS: numerical rating scale; RR: Risk ratio; VAS: Visual analogue scale; WOMAC: Western Ontario‐McMaster Osteoarthritis Scale. | ||||||
| GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
aLimitations in design and implementation of available studies suggest high likelihood of bias.
bImprecision: Results are based on only one study with 117 people.
cMany participants stopped their initial treatment because of lack of effect.