Patient-perceived Outcomes in Thigh Pain after Primary Arthroplasty of the Hip

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1 CLINICAL ORTHOPAEDICS AND RELATED RESEARCH Number 441, pp Lippincott Williams & Wilkins Patient-perceived Outcomes in Thigh Pain after Primary Arthroplasty of the Hip Carlos Lavernia, MD*; Michele D apuzzo, MD*; Victor Hugo Hernandez, MD*; and David J. Lee, PhD Thigh pain after arthroplasty first was identified in the joint replacement literature in 1988; little information has been published about the functional status of patients who develop this complication. Eleven patients who reported thigh pain at 2 years after cementless primary total hip arthroplasty were matched with patients who did not report thigh pain on the following characteristics: age, gender, diagnosis, bone type, and surgical procedure (ie, unilateral or bilateral). Preoperative WOMAC function scores were different in these two groups (53.5 versus 39.7). There were no differences in SF-36 and Quality of Well Being scores in the two patient groups. There were also no differences in the WOMAC, SF-36, and Quality of Well Being scores at the 2-year followup. However, item analysis of the WOMAC indicated that patients with thigh pain were more likely to report at least some functional deficit relative to patients without thigh pain at the 2-year followup. Thigh pain does not seem to affect 2-year postoperative quality of life severely in patients who have had cementless hip arthroplasties with a tapered stem design. Selected functional activities will be impacted by the presence of thigh pain. Level of Evidence: Prognostic study, Level III (case-control study). See the Guidelines for Authors for a complete description of levels of evidence. Enigmatic thigh pain has been the subject of multiple clinical investigations. Its presence in patients after cementless total hip arthroplasty (THA) ranges anywhere from 2% to 40%. 4,6,19 A number of factors have been associated with this problem, including the size and design of the stem. From the Orthopaedic Institute at Mercy Hospital and the University of Miami School of Medicine, Department of Epidemiology, Miami, FL. One or more of the authors (CL) has received funding from OREF, Zimmer, Mercy Foundation and Arthritis Surgery & Research Foundation. Each author certifies that his or her institution has approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research, and that informed consent was obtained. Correspondence to: Carlos J. Lavernia, MD, Orthopaedic Institute at Mercy Hospital, 3659 South Miami Avenue, Suite 4008, Miami, FL Phone: ; Fax: ; clavernia@mercymiami.org. DOI: /01.blo Other factors, including elastic moduli of the stem and the patient s bony architecture have not been confirmed to have a substantial effect on the development of thigh pain. 1,2,4,6 13,15,16,18 25 The consequences of thigh pain in the outcome of cementless THA have received little attention. Barrack et al 2 reported low but insignificant postoperative Harris hip score differences in a cohort of patients with thigh pain when compared with an asymptomatic matched cohort. Other surgeons have reported on operative intervention for the treatment of thigh pain. 2,10 It is clear in these series that the patients and their surgeons perceived this problem to be severe enough to require surgical intervention. Our objective was to assess the impact of thigh pain on patient-oriented outcomes and to study the resulting impediments in the patient s daily activities. Our primary research question is: Does thigh pain influence quality of life in patients who have had THA? We hypothesize that thigh pain adversely impacts quality of life in patients who have had THA. To test our hypotheses we matched patients with thigh pain who had cementless THA with patients who did not report thigh pain. Both patient groups were followed prospectively for a minimum of 2 years using patient-oriented outcomes. MATERIALS AND METHODS We first identified in our joint registry all patients who received a cementless primary THA by the senior author (CJL) who reported thigh pain after 2 years after surgery (n 19). We used a definition of thigh pain that was based on the pattern described by Barrack et al., 2 in which thigh pain was considered present when a patient-completed pain drawing showed that the shaded area was on the anterior view and below the inguinal area. The shaded area over the posterior thigh or gluteal region alone or pain that radiated all the way to the toes was not considered thigh pain. Four patients reported preoperative thigh pain and four did not have patient-oriented outcomes available at 2 years followup. We therefore excluded these patients from the analysis. 268

2 Number 441 December 2005 Thigh Pain and Patient-oriented Outcomes 269 The remaining 11 patients then were matched on age, gender, diagnosis, bone type, and surgical procedure (ie, unilateral or bilateral) with registry patients who did not report thigh pain during the same time period. One patient had a bilateral procedure. All patients had the Tri-Lock stem (DePuy, Warsaw, IN) implanted. This stem is a triple-tapered, straight, collarless, proximally coated stem. Patients had similar preoperative and postoperative care, including perioperative prophylaxis antibiotics and postoperative warfarin sodium for thromboembolism prophylaxis. The surgical technique used for all patients was a modified direct lateral approach using a press-fit technique for the femoral component and acetabular components. Screws were used for supplemental fixation in all patients. The polyethylene (PE) liner was sterilized using gas plasma. Full weightbearing was permitted as tolerated on postoperative Day 1. Femoral bone quality was assessed using the Dorr classification (Type A, B, or C). 10 Alignment, fit, and fixation of the femoral and acetabular components on an anteroposterior (AP) radiograph were assessed. Preoperative and postoperative pain information was collected using visual analogue scales (VAS). Patients were asked to highlight where the pain was located on an anterior and posterior drawing of the lower extremities; they then were asked to rate their intensity of the pain on the VAS from 0 (none) to 10 (severe). Preoperative and postoperative functional status and quality of life scales included an overall pain VAS, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC ), 3 the Quality of Well Being Index (QWB) 14 and the Short Form 36 (SF-36). 26 An item analysis was done for each WOMAC item assessed at the 2-year followup. Response options for each item, none, mild, moderate, severe, and extreme, were collapsed into two categories: none and mild-to-extreme. The QWB was developed by Kaplan et al 14 to assess general quality of life. This index has been validated for use in a variety of populations, including African-Americans and Latinos. Patients were followed up prospectively for a minimum of 2 years. Chi square, Fisher s Exact, and Mann-Whitney tests were used to compare group differences for categorical and continuously distributed data (SPSS, Chicago, IL). A p value < 0.05 was considered significant. RESULTS Mean preoperative patient age was similar in the patient groups reporting and not reporting 2-year postoperative thigh pain (Table 1). The ethnic and gender distribution of the two patient groups was identical as was the percentage of patients with bone Type B (73%) and orthopedic diagnosis (54% osteoarthritis). Preoperative WOMAC function scores were higher in the thigh pain versus no thigh pain group (53.5 versus 39.7; p < 0.05). There were no differences in SF-36 or QWB scores in the two patient groups. Two-year WOMAC pain and function scores were similar for patients reporting versus not reporting thigh pain at 2 years (Table 2). Average pain intensity ratings were higher (p < 0.001) in the patients reporting thigh pain (4.9 versus 0.2). There were no differences between these two groups on the QWB and the SF-36 scales, although the role physical subscale of the SF-36 was higher (p 0.07) in patients reporting versus not reporting thigh pain (75.0 versus 43.2). A number of the collapsed (two categories) WOMAC items distinguished patients reporting thigh pain at 2 years and in those cases patients were more likely to report functional deficit relative to patients not reporting thigh pain (Table 3). DISCUSSION Since the original report of thigh pain in 1988 by Callaghan et al, 8 several articles have been published on the etiology and treatment of thigh pain in cementless hip arthroplasty. 1,6,9,10,24 The incidence of thigh pain definitely has been associated with design-specific issues. Barrack et al 1 reported the effect of stem fixation and implant design on the incidence of this problem. The effects of elastic moduli of the implant have not been shown to be important in a tapered collarless stem design. 15,16 We reported on a series of 241 THAs with a tapered stem design in which the overall incidence of thigh pain was less than 10%. Several confounding factors have been associated with this pain pattern including loose stems as well as spinal disease. 5 Several study limitations should be noted. First, we did not collect detailed information on the circumstances surrounding the manifestation of thigh pain, nor did we assess the frequency and intensity of any reported thigh pain separately from overall pain. Second, because of our small sample size we were unable to detect as significant clinically relevant differences in functioning. For example, 2-year WOMAC total scores were 27.1 versus 18.2, respectively, in the thigh pain and no thigh pain groups. To detect this modest but clinically relevant difference as significant would have required a sample size of at least 150 patients. We did have the ability to identify larger differences in responses to individual WOMAC items (Table 3). We are unaware of other studies in which patientoriented outcomes were evaluated preoperatively and postoperatively in groups of patients who subsequently did and did not report thigh pain. The patients who went on to report thigh pain at the 2-year followup had lower levels of preoperative functioning as assessed by the WOMAC scale compared with the patients who subsequently did not develop thigh pain. This finding is consistent with previous reports indicating patients who delay presenting for surgery have poorer outcomes. 17 It is possible that this

3 270 Lavernia et al Clinical Orthopaedics and Related Research TABLE 1. Preoperative Demographic, Clinical and Functional Status in the Patients Reporting and Not Reporting Thigh Pain at the 2-Year Followup Demographic, Clinical, and Functional Status No Thigh Pain (n = 11) Thigh Pain (n = 11) Mean (%) SD Mean (%) SD Mann-Whitney/ Chi Square Age Female (%) 54.5 * Ethnicity (%) * Latino Nonlatino Bone Type B (%) * Diagnosis of Osteoarthritis (%) * QWB Total Pain intensity VAS WOMAC Pain Stiffness Function Total SF-36 Physical function Role physical Bodily pain General health Vitality score Social functioning Role emotional Mental health *Fisher s exact test not significant differences Wilcoxon; p < 0.05 QWB = Quality of Well Being Index; VAS = Visual analog scale; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index; SF-36 = Short Form-36; SD = Standard deviation group of patients who went on to develop thigh pain had waited for their function to deteriorate to a point where they could not recuperate as well as other patients who presented earlier for treatment. True enigmatic thigh pain has been studied in several papers in which the character, nature, and location of the pain have been carefully characterized. Barrack et al 2 reported a nonsignificant trend of lower Harris hip scores in patients with thigh pain when compared with a matched cohort. Although there were differences in the overall pain intensity reported by the two patient groups at the 2-year followup (Table 2), the average rating for the patients reporting thigh pain fell in the modest range of the scale (4.9) and was lower than the average preoperative ratings for this group (9.3). Our item analysis of the WOMAC scale administered at the 2-year followup also indicates that patients who reported thigh pain at that time were more likely to report at least some difficulties with selected functional activities such as rising from bed, rising from sitting, and doing heavy domestic duties. Skinner et al 22 has proposed a biomechanical theory for certain activities of daily living that can induce thigh pain based on the biomechanics of the bone stem composite. This could explain why these patients with thigh pain report disruption of certain activities of daily living. These possible thigh pain-associated effects should be noted when orthopaedic surgeons consent their surgical patients before cementless arthroplasty. It is also important to note that some of the thigh pain reported in the arthroplasty literature may not be related to this surgical procedure. As indicated earlier, we excluded from our analysis four patients who reported preoperative thigh pain and thigh pain at 2 years (Fig 1). Two of these patients probably had foraminal stenosis or lumbosacral arthritis as the primary etiology for enigmatic thigh pain. A review of the AP pelvis radiographs for these two patients showed significant arthritic changes at the lower lumbosacral spine. Arthrosis of the spine has not been excluded as a potential causative agent in most thigh pain series. This could resolve the enigma on a number of these cases and also lead to more precise studies designed

4 Number 441 December 2005 Thigh Pain and Patient-oriented Outcomes 271 TABLE 2. Functional Status in Patients with and without Thigh Pain at 2-Year Followup No Thigh Pain (n = 11) Thigh Pain (n = 11) Outcomes Mean (%) SD Mean (%) SD Mann-Whitney/ Chi Square QWB* total WOMAC Pain Stiffness Function Total Pain intensity VAS* SF-36 Physical function Role physical Bodily pain General health Vitality score Social functioning Role emotional Mental health *p < 0.05; Wilcoxon W QWB = Quality of Well Being Index; VAS = Visual analog scale; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index; SF-36 = Short Form-36; SD = Standard deviation to predict the development of arthroplasty-related thigh pain. Brown et al 5 showed the utility of pain diagrams in a cohort of patients in a spine practice. We also show the usefulness of a pain diagram in evaluating patients who have had arthroplasties. The senior author routinely uses preoperative pain diagram findings to identify patients with spinal stenosis symptoms. Patients with spinalstenosis type symptoms are informed before surgery that postoperative outcomes with respect to pain relief, functional status, and quality of life could be less than optimal given the presence of this comorbid condition. We suggest that pain does not appear to affect 2-year postoperative quality of life severely in patients who have had cementless hip arthroplasties with a tapered stem design. However, selected functional activities are impacted substantially by the presence of thigh pain. Longitudinal studies of patients who have had arthroplasties are needed to characterize the incidence of thigh pain better and to identify functional and quality of life consequences. TABLE 3. WOMAC Items That Significantly Discriminate between Patients with and without Thigh Pain at 2-Year Followup WOMAC Individual Items 2-Year Thigh Pain Status No Thigh Pain (n = 11) Thigh Pain (n = 11) Reported No Limitation (%) Reported No Limitation (%) Chi Square WOMAC pain Walking on a flat surface * Sitting or lying * WOMAC function Ascending stairs Rising from sitting Rising from bed * Getting on/off toilet * Heavy domestic duties 46 0 *p < 0.05 Fisher s Exact Test p < 0.05 WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index

5 272 Lavernia et al Clinical Orthopaedics and Related Research Fig 1A B. Completed (A) preoperative and (B) postoperative pain diagrams of a patient with persistent thigh pain are shown. References 1. Barrack RL, Jasty M, Bragdon C, Haire T, Harris WH: Thigh pain despite bone ingrowth into uncemented femoral stems. J Bone Joint Surg 74B: , Barrack RL, Paprosky W, Butler RA, et al: Patients perception of pain after total hip arthroplasty. J Arthroplasty 15: , Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW: Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15: , Bourne RB, Rorabeck CH, Patterson JJ, Guerin J: Tapered titanium cementless total hip replacements: A 10- to 13-year followup study. Clin Orthop Relat Res 393: , Brown MD, Gomez-Marin O, Brookfield KF, Li PS: Differential diagnosis of hip disease versus spine disease. Clin Orthop Relat Res 419: , Brown TE, Larson B, Shen F, Moskal JT: Thigh pain after cementless total hip arthroplasty: Evaluation and management. J Am Acad Orthop Surg 10: , Burkart BC, Bourne RB, Rorabeck CH, Kirk PG: Thigh pain in cementless total hip arthroplasty: A comparison of two systems at 2 years follow-up. Orthop Clin North Am 24: , Callaghan JJ, Dysart SH, Savory CG: The uncemented porouscoated anatomic total hip prosthesis: Two-year results of a prospective consecutive series. J Bone Joint Surg 70A: , Campbell AC, Rorabeck CH, Bourne RB, Chess D, Nott L: Thigh pain after cementless hip arthroplasty: Annoyance or ill omen. J Bone Joint Surg 74B:63 66, Domb B, Hostin E, Mont MA, Hungerford DS: Cortical strut grafting for enigmatic thigh pain following total hip arthroplasty. Orthopedics 23:21 24, Dorr LD, Faugere MC, Mackel AM, et al: Structural and cellular assessment of bone quality of proximal femur. Bone 14: , Hamada Y, Akamatsu N, Nakajima I, et al: Thigh pain in cementless total hip replacement. Nippon Seikeigeka Gakkai Zasshi 67: , Herzwurm PJ, Simpson SL, Duffin S, Oswald SG, Ebert FR: Thigh pain and total hip arthroplasty: Scintigraphy with 2.5-year followup. Clin Orthop Relat Res 336: , Kaplan RM, Alcaraz JE, Anderson JP, Weisman M: Qualityadjusted life years lost to arthritis: Effects of gender, race, and social class. Arthritis Care Res 9: , Kim YH: Titanium and cobalt-chrome cementless femoral stems of identical shape produce equal results. Clin Orthop Relat Res 1: , Lavernia C, D Apuzzo M, Hernandez VH, Lee D: Thigh pain in primary total hip arthroplasty: the effects of elastic moduli. J Arthroplasty 19:10 16, Fortin PR, Penrod JR, Clarke AE, et al: Timing of total joint replacement affects clinical outcomes among patients with osteoarthritis of the hip or knee. Arthritis Rheum 46: , Maloney WJ, Harris WH: Comparison of a hybrid with an uncemented total hip replacement: A retrospective matched-pair study. J Bone Joint Surg 72A: , Meding JB, Keating EM, Ritter MA, Faris PM, Berend ME: Minimum ten-year follow-up of a straight-stemmed, plasma-sprayed, titanium-alloy, uncemented femoral component in primary total hip arthroplasty. J Bone Joint Surg 86A:92 97, Moskal JT, Jordan L, Brown TE: The porous-coated anatomic total hip prosthesis: 11- to 13-year results. J Arthroplasty 19: , Namba RS, Keyak JH, Kim AS, Vu LP, Skinner HB: Cementless implant composition and femoral stress: A finite element analysis. Clin Orthop Relat Res 347: , 1998.

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