A randomized controlled trial comparing the Thompson hemiarthroplasty with the Exeter polished tapered stem and Unitrax modular head in the treatment of displaced intracapsular fractures of the hip: the WHiTE 3: HEMI Trial

Abstract

Aims: This study aimed to compare the change in health-related quality of life of patients receiving a traditional cemented monoblock Thompson hemiarthroplasty compared with a modern cemented modular polished-taper stemmed hemiarthroplasty for displaced intracapsular hip fractures.

Patients and methods: This was a pragmatic, multicentre, multisurgeon, two-arm, parallel group, randomized standard-of-care controlled trial. It was embedded within the WHiTE Comprehensive Cohort Study. The sample size was 964 patients. The setting was five National Health Service Trauma Hospitals in England. A total of 964 patients over 60 years of age who required hemiarthroplasty of the hip between February 2015 and March 2016 were included. A standardized measure of health outcome, the EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and at four months following the operation.

Results: Of the 964 patients enrolled, 482 died or were lost to follow-up (50%). No significant differences were noted in EQ-5D between groups, with a mean difference at four months of 0.037 in favour of the Exeter/Unitrax implant (95% confidence interval (CI) 0.014 to 0.087, p = 0.156), rising to 0.045 (95% CI 0.007 to 0.098, p = 0.09) when patients who died were excluded. The minimum clinically important difference for EQ-5D-5L used in this study is 0.08, therefore any benefit between implants is unlikely to be noticeable to the patient. There was no difference in mortality or mobility score.

Conclusion: Allowing for the high rate of loss to follow-up, the use of the traditional Thompson hemiarthroplasty in the treatment of the displaced intracapsular hip fracture shows no difference in health outcome when compared with a modern cemented hemiarthroplasty. Cite this article: Bone Joint J 2018;100-B:352-60.

Keywords: Exeter; Femoral neck; Fracture; Hemiarthroplasty; Hip; Polished stem; Randomized controlled trial; Thompson; Unitrax.

Fig. 1

Plain radiograph of a cemented Thompson monoblock hemiarthroplasty.

Fig. 2

Plain radiograph of a cemented Exeter polished taper stem with a Unitrax head (modular implant).

Fig. 3

Postoperative change in EuroQol five domain questionnaire (EQ-5D) following hip fracture surgery. The dashed line indicates the baseline preoperative EQ-5D. (Reprinted from X. L. Griffin, N. Parsons, J. Achten, M. Fernandez, M. L. Costa. Recovery of health-related quality of life in a United Kingdom hip fracture population, the Warwick Hip Trauma Evaluation - a prospective cohort study. Bone Joint J 2015;97-B:372-382.)

Fig. 4

Graph showing recruitment of patients for this trial. The target, 964 patients, was achieved ahead of schedule.

Fig. 5

Consolidated Standards of Reporting Trials (CONSORT) flowchart.

Figs. 6a - 6b

Graph showing the length of hospital stay (LOS) in days, from study recruitment to discharge, for a) Thompson and b) Exeter/Unitrax implants. The first column of each graph refers to a LOS of 0 days, the second column refers to a LOS of one day and so on.

Figs. 6a - 6b

Graph showing the length of hospital stay (LOS) in days, from study recruitment to discharge, for a) Thompson and b) Exeter/Unitrax implants. The first column of each graph refers to a LOS of 0 days, the second column refers to a LOS of one day and so on.

Figs. 7a - 7b

Graph showing the distribution of difference in neck length (mm), for a) Thompson and b) Exeter/Unitrax implants, divided into 5 mm categories: -35 mm to -30 mm; -30 mm to -25 mm; -25 mm to -20 mm; and so on. The vertical dashed lines indicate the mean values.

Figs. 7a - 7b

Graph showing the distribution of difference in neck length (mm), for a) Thompson and b) Exeter/Unitrax implants, divided into 5 mm categories: -35 mm to -30 mm; -30 mm to -25 mm; -25 mm to -20 mm; and so on. The vertical dashed lines indicate the mean values.