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

Bone Joint J. 2018 Mar 1;100-B(3):352-360. doi: 10.1302/0301-620X.100B3.BJJ-2017-0872.R2.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Pragmatic Clinical Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Female
  • Follow-Up Studies
  • Fracture Dislocation / surgery*
  • Health Status Indicators
  • Hemiarthroplasty / instrumentation*
  • Hemiarthroplasty / methods
  • Hip Fractures / surgery*
  • Hip Prosthesis*
  • Humans
  • Intra-Articular Fractures / surgery*
  • Linear Models
  • Male
  • Middle Aged
  • Quality of Life*
  • Single-Blind Method
  • Treatment Outcome