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Clinical Orthopaedics and Related Research®

, Volume 472, Issue 11, pp 3517–3522 | Cite as

Bilateral Clubfeet Are Highly Correlated: A Cautionary Tale for Researchers

  • Kelly GrayEmail author
  • Paul Gibbons
  • David Little
  • Joshua Burns
Clinical Research

Abstract

Background

Congenital talipes equinovarus, or clubfoot, is a common pediatric orthopaedic condition of unknown origin. In many clubfoot clinical trials, interventions are assigned to a patient, but response to treatment is assessed separately in each foot. Trials commonly report x patients with y feet where y is greater than x (eg, 35 patients with 56 feet). However, common statistical tests assume that each data point is independent. Although data from unilateral cases of clubfoot are independent, it is unknown if each foot of patients with bilateral clubfeet are correlated.

Questions/purposes

The purpose of this study was to assess the correlation in the feet of patients with bilateral clubfeet by (1) evaluating the degree of severity between lower limbs of each patient with bilateral clubfeet at baseline; (2) determining if right and left feet of each patient responded to intervention in the same way; (3) determining the proportion of bilateral relapse; and (4) determining the proportion of right and left feet which required the same intervention to correct bilateral relapse.

Methods

We performed a chart review of the records of 33 patients with bilateral clubfeet (66 feet). Baseline severity was assessed using the Pirani score. The number of Ponseti serial casts to correct the deformity, the proportion of patients who underwent bilateral Achilles tenotomy, the proportion of bilateral relapse, and the treatment to correct bilateral relapse were examined.

Results

The degree of severity between right (Pirani score mean, 5.2; SD, 0.8) and left (Pirani score mean, 5.2; SD, 0.5) feet for each patient at baseline was highly correlated (r = 0.76, p < 0.001). Response to intervention between lower limbs was highly correlated for the number of Ponseti casts required for initial correction (right mean, 5.2, SD, 1.1; left mean, 5.2, SD, 1.3) (r = 0.89, p < 0.001) and the proportion of patients who underwent bilateral Achilles tenotomy (right, 17/18; left, 16/18) (r = 0.94, p < 0.001). In the nine patients who experienced relapse, eight experienced bilateral involvement. In all cases of bilateral relapse, the right and left foot of each patient required the same intervention to correct the relapse.

Conclusions

In patients with bilateral clubfeet, baseline severity, response to initial Ponseti treatment, Achilles tenotomy, and relapse outcomes were highly correlated in the right and left feet of each patient. Pooling clinical results of patients who present with bilateral clubfeet is statistically inappropriate, since results in two limbs of the same patient do not represent independent observations. These results support analogous work in other specialties suggesting that patients with bilateral presentations should not be analyzed as independent data points.

Level of Evidence

Level IV, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.

Keywords

Clubfoot Bilateral Involvement Bilateral Case Baseline Severity Ponseti Method 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© The Association of Bone and Joint Surgeons® 2014

Authors and Affiliations

  • Kelly Gray
    • 1
    • 4
    Email author
  • Paul Gibbons
    • 2
    • 4
  • David Little
    • 2
    • 4
  • Joshua Burns
    • 3
    • 4
  1. 1.Physiotherapy DepartmentThe Children’s Hospital at WestmeadSydneyAustralia
  2. 2.Department of Orthopaedic SurgeryThe Children’s Hospital at WestmeadSydneyAustralia
  3. 3.Paediatric Gait Analysis Service of NSWThe Children’s Hospital at WestmeadSydneyAustralia
  4. 4.The University of SydneySydneyAustralia

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