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Higher rate of complications with uncemented compared to cemented total hip arthroplasty for displaced intracapsular hip fractures: A randomised controlled trial of 50 patients.

ABSTRACT:

Background

The primary aim of this study was to compare the functional outcome of uncemented with cemented total hip arthroplasty (THA) for displaced intracapsular hip fractures. The secondary aims were to assess length of surgery, blood loss, complications and revision rate between the two groups.

Methods

A prospective double-blind randomised control trial was conducted. Fifty patients with an intracapsular hip fracture meeting the inclusion criteria were randomised to either an uncemented (n = 25) or cemented (n = 25) THA. There were no differences (p > 0.45) in age, gender, health status or preinjury hip function between the groups. The Oxford hip score (OHS), Harris Hip score (HHS), EuroQol 5-dimensional (EQ5D), timed get up-and-go (TUG), pain and patient satisfaction were used to assess outcome. These were assessed at 4, 12 and 72 months after surgery, apart from the TUG which as only assessed as 6 months.

Results

The study was terminated early due to the significantly (n = 8, p = 0.004) higher rate of intraoperative complications in the uncemented group: three fractures of the proximal femur and five conversions to a cemented acetabular component. There were no significant (p ≥ 0.09) differences in the functional measures (OHS, HSS, EQ5D, TUG and pain) or patient satisfaction between the groups. There was no difference in operative time (p = 0.75) or blood loss (p = 0.66) between the groups. There were two early revisions prior to 3 months post-operatively in the uncemented group and none in the cemented group, but this was not significant (log rank p = 0.16).

Conclusion

There was a high rate of intraoperative complications, which may be due to poor bone quality in this patient group. There were no ergonomic or functional advantages demonstrated between uncemented and cemented THA. Cemented THA should remain as the preferred choice for the treatment of intracapsular hip fractures for patients that meet the criteria for this procedure.

SUBMITTER: Clement ND

PROVIDER: S-EPMC7981295 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:INTRODUCTION:Hip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture. METHODS AND ANALYSIS:Multicentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4?months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12?months and health resource use. A within-trial economic analysis will be conducted. ETHICS, DISSEMINATION AND FUNDING:Wales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215-36043 and PB-PG-1216-20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres. TRIAL REGISTRATION NUMBER:ISRCTN18393176.

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