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The Role of Patient Restrictions in Reducing the Prevalence of Early Dislocation Following Total Hip ArthroplastyA Randomized, Prospective Study
E. Louis Peak, MD1; Javad Parvizi, MD, FRCS1; Michael Ciminiello, MD1; James J. Purtill, MD1; Peter F. Sharkey, MD1; William J. Hozack, MD1; Richard H. Rothman, MD, PhD1
1 Rothman Institute, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107. E-mail address for J. Parvizi: parvj@aol.com
View Disclosures and Other Information
The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.
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Investigation performed at the Department of Orthopaedic Surgery, the Rothman Institute of Orthopaedics at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2005 Feb 01;87(2):247-253. doi: 10.2106/JBJS.C.01513
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Abstract

Background: It is currently unknown whether functional restrictions following total hip arthroplasty can reduce the prevalence of early postoperative dislocation. Our hypothesis was that dislocation was more likely to occur in patients who were not placed on these restrictions.

Methods: We performed a prospective, randomized study to evaluate the role of postoperative functional restrictions on the prevalence of dislocation following uncemented total hip arthroplasty through an anterolateral approach. Of the 630 eligible consecutive patients, 265 patients (303 hips) consented to be randomized into one of two groups (the "restricted" group or the "unrestricted" group). The patients in both groups were asked to limit the range of motion of the hip to <90° of flexion and 45° of external and internal rotation and to avoid adduction for the first six weeks after the procedure. The patients in the restricted group were instructed to comply with additional hip precautions during the first six weeks postoperatively. Specifically, these patients were managed with the placement of an abduction pillow in the operating room before bed transfer and used pillows to maintain abduction while in bed; used elevated toilet seats and elevated chairs in the hospital, in the rehabilitation facility, and at home; and were prevented from sleeping on the side, from driving, and from being a passenger in an automobile. All patients were followed for a minimum of six months postoperatively.

Results: There was one dislocation in the entire cohort (prevalence, 0.33%). This dislocation occurred in a patient in the restricted group during transfer from the operating table to a bed with an abduction pillow in place. Patients in the unrestricted group were found to return to side-sleeping sooner (p < 0.001), to ride in automobiles more often (p < 0.026), to drive automobiles more often (p < 0.001), to return to work sooner (p < 0.001), and to have a higher level of satisfaction with the pace of their recovery (p < 0.001) than those in the restricted group. There was an additional expenditure of approximately $655 per patient in the restricted group.

Conclusions: Total hip arthroplasty through an anterolateral approach is likely to be associated with a low dislocation rate. Removal of several restrictions did not increase the prevalence of dislocation following primary hip arthroplasty at our institution. However, it did promote substantially lower costs and was associated with a higher level of patient satisfaction as patients achieved a faster return to daily functions in the early postoperative period.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    References

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Javad Parvizi, M.D.
    Posted on May 20, 2005
    Dr Parvizi and colleagues respond to Drs Cummins and Weinstein
    Rothman Institute

    We thank Drs. Cummins and Weinstein for their interest in our article and for their shrewd comments.

    The ‘expected’ three fold increase in dislocation rate was determined after extensive review of the literature and discussions with various arthroplasty surgeons. However, because of lack of any report in the literature pertinent to this subject, we could not select the difference (delta) based on historic publications. We chose the smallest possible difference between the groups in order to ‘overpower’ the study. We agree with the authors that one would expect to observe a substantial, and hopefully much more than a three fold, reduction in the incidence of dislocation by implementation of these restrictions.

    We were cognizant of the importance of power analysis for this study. Statistical advice had been sought prior to initiation of the study and the size of the patient population was determined based on that advice. The power analysis was performed using the method described by Joseph L. Fleiss in the book Statistical Methods for Rates and Proportions.(1) This book is the authoritative text in the statistical field on comparative studies using rates and proportions. Using the methods from Chapter 3, "Determining Sample Sizes Needed to Detect a Difference Between Two Proportions", we set significance level á to be 0.05 and the power to be 0.80 for a one-tailed test of dislocation rates between the two groups. The rate of dislocation was determined to be low at approximately 1 percent. Since the dislocation rate was set to be so low, the lowest incidence table (TableA.3, p.260) was utilized. For a power of 0.80, and to detect a three-fold difference, a minimum sample size of 130 was needed in each group for this study. The method elected to determine the power for this study is well accepted, validated, and previously utilized by numerous investigators. However, despite our initial power analysis that determined that a population of 130 patients in each arm of the study would be sufficient, we decided to recruit a higher number of patients to account for attrition. There were no patients lost to follow-up. Based on our initial statistical evaluations and the consequent detailed examination of our protocol, we are confident that the patient population recruited into this study is markedly higher than one needed to avoid a type II error even with such a small rate of dislocation.

    Although the dislocation rate for the ‘experimental’ patient population at the conclusion of the study did not happen to be two or three times higher than the ‘control’ group, this does not detract from the validity of the statistical methods used to determine the sample size.

    The main objective of the study was to evaluate the dislocation rate. Furthermore, the validity of the conclusions of our study has been confirmed in a recent analysis of the dislocation rate in 1000 patients at our institution. The dislocation rate for these patients who were not subjected to the restrictions mentioned in the study was 0.6 (2).

    Respectfully:

    Louis Peak MD

    Javad Parvizi MD

    Richard H Rothman MD, PhD

    (1)Joseph L. Fleiss in the book Statistical Methods for Rates and Proportions , 2nd edition, 1981, John Wiley & Sons Inc., New York, pp. 42-44, 260.

    (2)Sharkey PF, Parvizi J, Hozack WJ, Rothman RH. Ultra-High Volume and Early Outcomes of Primary and Revision Total Hip Arthroplasty. J Arthroplasty 19(6): 694-9, 2004

    Justin S. Cummins
    Posted on April 28, 2005
    Total Hip Arthroplasty Dislocations and Power Analysis for Rare Events
    Dartmouth Hitchcock Medical Center

    To the editor:

    In the article by Peak et al, entitled “The Role of Patient Restrictions in Reducing the Prevalence of Early Dislocation Following Total Hip Arthroplasty” (Peak et al, J Bone Joint Surg Am. 2005; 87: 247- 253), the authors bring high quality data to an area where few studies exist.

    After reviewing the methods section of the paper, there are two specific concerns and questions for the authors: First, why is a threefold difference in dislocation rates chosen as the threshold for detecting a difference between the two groups? As noted by the authors, multiple factors may contribute to dislocations in the early postoperative period, including surgical approach and implant position. Thus, it is difficult to imagine that discontinuing the use of an abduction pillow and a high toilet seat, as well as not riding in a car would result in a threefold increase in dislocation rates. This implies that if restrictions resulted in a 50% decrease in dislocations, they would still not be worthwhile to implement.

    A second concern relates to the power calculation. With the numbers given in the article (alpha – 0.05, beta – 0.20, baseline dislocation rate – 1.0%), and attempting to power the study to detect a threefold difference, a much larger study group is needed. Using the method illustrated in a recent paper by Lochner et al.(1) for estimating the sample size needed to detect a difference in proportions, a minimum of 760 patients in each group would be needed to detect a threefold difference in dislocation rates. A more precise estimate using STATA (2) statistical software indicates that 866 patients would be needed for each group in order to appropriately minimize the risk of a type-II error. With the number of patients enrolled in this trial, the power is approximately 13% (beta = .87), which makes the risk of a type-II error very high.

    Given the high threshold for detecting a difference and the apparent lack of sufficient statistical power, I would be hesitant to conclude that no difference exists between the restricted and unrestricted groups in regard to dislocation rate. Thank you for considering these comments and congratulations on your work.

    References

    1. Lochner H, Bhandari M, Tornetta P. Type-II error rates (beta errors) of randomized trials in orthopedic trauma. J Bone Joint Surg Am. 2001; 83: 1650-1655.

    2. STATA version 8.2, 2004. StataCorp, College Station, TX 77845.

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