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

A L Sims, N Parsons, J Achten, X L Griffin, M L Costa, M R Reed, CORNET trainee collaborative, O Sabri, A Gray, S Green, P Baker, W Eardley, J Davison, A Bennett, A Cooney, A Desai, A Farrier, A Mills, A Carrington, A Myatt, A Pujol-Nicolas, A Clarke, A Assad, A Scrimshire, A Wanton, B Ahmed, B Winger, B Siddiqui, D Hipps, D Dowen, D Lees, E Henein, E Jeans, E Oderuth, F Ashouri, F Ashton, H Chandler, H Iqbal, H Ingoe, H Vint, J Rahman, J Kent, J Penn-Barwell, K Dwyer, K Ghosh, K Kursumovic, L Rohman, L Railton, L Walker, M Ramappa, M Diament, M Sohatee, M Marsh, M Bardgett, M El-Gendy, M Rymaszewska, M Adeel Akhtar, M Iqbal, M Madhavan, M Mawdsley, M Mansha, M Webb, N Agni, N Green, N Kalson, N Hutt, P Middleton, P Rushton, P Brown, P Henman, P Jettoo, R Sidaginamale, R Taranu, R Critchley, R Holleyman, R Hutchinson, R Rai, R Morrell, R Morrison, R Begum, R Rafaie, R Varrall, S K Khan, S Mahmoud, S Eastwood, S Johnson-Lynn, S Jameson, S Bell, T Brock, T Wharton, W Manning, Z Gamie, D Inman, D Kramer, D Townshend, R Pratt, J Coorsh, S Venkatachalam, J Candal-Couto, R Kakwani, I Carluke, K Emmerson, C Gibbons, S Jones, J Joseph, A Malviya, S Muller, A Murty, P Partington, C Jensen, S Aldridge, P Henman, J Williams, T Beckingsale, P Fearon, W Bliss, P Worlock, P Dixon, S Aldridge, S Bhatangar, P Bansal, S Dalal, G De-Kiewiet, M Krishnan, P Lakshmanan, A Nanu, S O'Brien, I Talkhani, Y Michla, B Puroshothaman, S Klenka, J McVie, F Yaish, J Webb, R Hopcroft, M Al-Maiyah, I McMurtry, R Liow, C White, R Tate, W Eardley, I Wallace, L Van Niekerk, T Hui, P MacKenney, A Best, L Cutler, J Mangwani, R Pandey, U Chatterji, K Lammin, A Modi, C Wildin, S Williams, A Abraham, A Armstrong, A Brown, S Hutchings, A Kulkarni, H Singh, M Bhatia, G Taylor, A Ullah, A L Sims, N Parsons, J Achten, X L Griffin, M L Costa, M R Reed, CORNET trainee collaborative, O Sabri, A Gray, S Green, P Baker, W Eardley, J Davison, A Bennett, A Cooney, A Desai, A Farrier, A Mills, A Carrington, A Myatt, A Pujol-Nicolas, A Clarke, A Assad, A Scrimshire, A Wanton, B Ahmed, B Winger, B Siddiqui, D Hipps, D Dowen, D Lees, E Henein, E Jeans, E Oderuth, F Ashouri, F Ashton, H Chandler, H Iqbal, H Ingoe, H Vint, J Rahman, J Kent, J Penn-Barwell, K Dwyer, K Ghosh, K Kursumovic, L Rohman, L Railton, L Walker, M Ramappa, M Diament, M Sohatee, M Marsh, M Bardgett, M El-Gendy, M Rymaszewska, M Adeel Akhtar, M Iqbal, M Madhavan, M Mawdsley, M Mansha, M Webb, N Agni, N Green, N Kalson, N Hutt, P Middleton, P Rushton, P Brown, P Henman, P Jettoo, R Sidaginamale, R Taranu, R Critchley, R Holleyman, R Hutchinson, R Rai, R Morrell, R Morrison, R Begum, R Rafaie, R Varrall, S K Khan, S Mahmoud, S Eastwood, S Johnson-Lynn, S Jameson, S Bell, T Brock, T Wharton, W Manning, Z Gamie, D Inman, D Kramer, D Townshend, R Pratt, J Coorsh, S Venkatachalam, J Candal-Couto, R Kakwani, I Carluke, K Emmerson, C Gibbons, S Jones, J Joseph, A Malviya, S Muller, A Murty, P Partington, C Jensen, S Aldridge, P Henman, J Williams, T Beckingsale, P Fearon, W Bliss, P Worlock, P Dixon, S Aldridge, S Bhatangar, P Bansal, S Dalal, G De-Kiewiet, M Krishnan, P Lakshmanan, A Nanu, S O'Brien, I Talkhani, Y Michla, B Puroshothaman, S Klenka, J McVie, F Yaish, J Webb, R Hopcroft, M Al-Maiyah, I McMurtry, R Liow, C White, R Tate, W Eardley, I Wallace, L Van Niekerk, T Hui, P MacKenney, A Best, L Cutler, J Mangwani, R Pandey, U Chatterji, K Lammin, A Modi, C Wildin, S Williams, A Abraham, A Armstrong, A Brown, S Hutchings, A Kulkarni, H Singh, M Bhatia, G Taylor, A Ullah

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.

Figures

Fig. 1
Fig. 1
Plain radiograph of a cemented Thompson monoblock hemiarthroplasty.
Fig. 2
Fig. 2
Plain radiograph of a cemented Exeter polished taper stem with a Unitrax head (modular implant).
Fig. 3
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
Fig. 4
Graph showing recruitment of patients for this trial. The target, 964 patients, was achieved ahead of schedule.
Fig. 5
Fig. 5
Consolidated Standards of Reporting Trials (CONSORT) flowchart.
Figs. 6a - 6b
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
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
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
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.

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Source: PubMed

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