No Clinically Important Differences in Thigh Pain or Bone Loss Between Short Stems and Conventional-length Stems in THA: A Randomized Clinical Trial

全髋关节置换术中短柄假体与常规长度假体在股骨疼痛或骨丢失方面无临床意义上的差异:一项随机临床试验

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Abstract

BACKGROUND: Short-length stems were developed to reduce bone loss of the proximal femur and potentially decrease the incidence of thigh pain after cementless THA. However, it remains unknown whether short stems indeed reduce bone loss or the frequency of thigh pain. QUESTIONS/PURPOSES: Is there a difference between short- and standard-length stems in terms of: (1) the frequency or severity of thigh pain, (2) modified Harris hip scores, (3) implant loosening, or (4) bone mineral density as measured by dual-energy x-ray absorptiometry? METHODS: Between March 2013 and January 2014, three surgeons performed 205 primary THAs. To be eligible, patients needed to be at least 20 years of age, have not undergone previous history of hip surgery, and have no metabolic bone disease. A total of 100 patients were randomized to receive THA either with a short stem (n = 56) or with a standard-length stem (n = 44). Both stems were proximally coated, tapered, cementless stems. Compared with standard stems, short stems typically were 30- to 35-mm shorter. A total of 73% (41 of 56) and 77% (34 of 44) of those groups, respectively, were accounted for at a minimum of 5 years and were analyzed. The presence of thigh pain during activity was evaluated using a 10-point VAS, and the modified Harris hip score was calculated by research assistants who were blinded to the treatment groups. Plain radiographs were taken at 6 weeks, 6 months, and 12 months postoperatively, and every 1 year thereafter; loosening was defined as subsidence > 3 mm or a position change > 3° on serial radiographs. Radiological assessment was performed by two researchers who did not participate in the surgery and follow-up evaluations. Bone mineral density of the proximal femur was measured using dual-energy x-ray absorptiometry at 4 days, 1 year, 2 years, and 5 years postoperatively. The primary endpoint of our study was the incidence of thigh pain during 5-year follow-up. Our study was powered at 80% to detect a 10% difference in the proportion of patients reporting thigh pain at the level of 0.05. RESULTS: With the numbers available, we found no difference between the groups in the proportion of patients with thigh pain; 16% (9 of 56) of patients in the short-stem group and 14% (6 of 44) of patients in the standard-stem group experienced thigh pain during the follow-up period (p = 0.79). In all patients, the pain was mild or moderate (VAS score of 4 or 6 points). Among the 15 available patients who reported thigh pain, there was no difference between the implant groups in mean severity of thigh pain (4.3 ± 0.8 versus 4.2 ± 0.7; p = 0.78). There were no between-group differences in the short versus standard-length stem groups in terms of mean modified Harris hip score by 5 years after surgery (89 ± 13 versus 95 ± 7 points; p = 0.06). No implant was loose and no hip underwent revision in either group. Patients in the short-stem group showed a slightly smaller decrease in bone mineral density in Gruen Zones 2, 3, and 5 than those in the standard-stem group did; the magnitude of the difference seems unlikely to be clinically important. CONCLUSION: We found no clinically important differences (and few differences overall) between short and standard-length THA stems 5 years after surgery in a randomized trial. Consequently, we recommend that clinicians use standard-length stems in general practice because standard-length stems have a much longer published track record in other studies, and short stems can expose patients to the uncertainty associated with novelty, without any apparent offsetting benefit. LEVEL OF EVIDENCE: Level I, therapeutic study.

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