TRAUMA

Hemiarthroplasty using cemented or uncemented stems of proven design A COMPARATIVE STUDY G. Grammatopoulos, H. A. Wilson, B. J. L. Kendrick, E. C. Pulford, J. Lippett, M. Deakin, A. J. Andrade, G. Kambouroglou From Trauma Unit, JR Hospital, Headley Way Oxford, United Kingdom  G. Grammatopoulos, DPhil, FRCS (Tr&Orth), Orthopaedic Trainee  B. J. L. Kendrick, DPhil, FRCS (Tr&Orth), Arthroplasty Fellow Nuffield Orthopaedic Centre, Botnar Research Centre, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, OX3 7LD, UK.  H. A. Wilson, MBBS, MRCS, Orthopaedic Trainee  J. Lippett, FRCP, MSc, MBBS, Consultant Orthogeriatrician  A. J. Andrade, MBBS MSc FRCS(Tr&Orth), Consultant Trauma and Orthopaedic Surgeon Royal Berkshire NHS Foundation Trust, London Road, Reading, Berkshire RG1 5AN, UK.  E. C. Pulford, FRCP MEd, Clinical Lead. Geratology & Stroke Consultant Physician, Trauma/Geratology  M. Deakin, MSc FRCS, Consultant Orthopaedic Trauma Surgeon  G. Kambouroglou, MD, Consultant Orthopaedic Trauma Surgeon John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, UK. Correspondence should be sent to Mr G. Grammatopoulos; e-mail: George.grammatopoulos @ndorms.ox.ac.uk ©2015 The British Editorial Society of Bone & Joint Surgery doi:10.1302/0301-620X.97B1. 34138 $2.00 Bone Joint J 2015;97-B:94–9. Received 23 March 2014; Accepted after revision 18 September 2014

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National Institute of Clinical Excellence guidelines state that cemented stems with an Orthopaedic Data Evaluation Panel (ODEP) rating of > 3B should be used for hemiarthroplasty when treating an intracapsular fracture of the femoral neck. These recommendations are based on studies in which most, if not all stems, did not hold such a rating. This case-control study compared the outcome of hemiarthroplasty using a cemented (Exeter) or uncemented (Corail) femoral stem. These are the two prostheses most commonly used in hip arthroplasty in the UK. Data were obtained from two centres; most patients had undergone hemiarthroplasty using a cemented Exeter stem (n = 292/412). Patients were matched for all factors that have been shown to influence mortality after an intracapsular fracture of the neck of the femur. Outcome measures included: complications, re-operations and mortality rates at two, seven, 30 and 365 days post-operatively. Comparable outcomes for the two stems were seen. There were more intra-operative complications in the uncemented group (13% vs 0%), but the cemented group had a greater mortality in the early post-operative period (n = 6). There was no overall difference in the rate of re-operation (5%) or death (365 days: 26%) between the two groups at any time post-operatively. This study therefore supports the use of both cemented and uncemented stems of proven design, with an ODEP rating of 10A, in patients with an intracapsular fracture of the neck of the femur. Cite this article: Bone Joint J 2015;97-B:94–9.

Fractures of the neck of the femur are a major public health issue. There are 70 000 to 75 000 new cases each year in the UK, with an associated financial burden of more than £2 billion.1 The reported 30- and 365-day rates of mortality are 10% and 30%, respectively.1 This is three times the expected mortality rate of an 85-year old man residing in the UK, which is reported to be 10% at one year.2 The National Institute of Clinical Excellence (NICE) has produced guidelines for the management of patients with a fractured neck of femur.1 It recommends the use of a cemented femoral prosthesis of proven design only, that is one that has a minimum Orthopaedic Data Evaluation Panel (ODEP) rating of 3B. It does not recommend the use of Thompson’s (Stryker UK Ltd, Newbury, UK) or Austin Moore’s (DePuy, Warsaw, Indiana) hemiarthroplasties, neither of which have an ODEP rating. The cemented Exeter stem (Stryker, Newbury, UK) and the uncemented Corail stem (DePuy, Warsaw, Indiana) have the best ODEP rating (10A).

Most of the literature reviewed by NICE supporting the use of a cemented rather than an uncemented prosthesis compared Thompson’s with Austin Moore’s,3-5 or reported on National Joint Registry data,6 with the above two prostheses being the most commonly used. There have only been a few studies which report the use of hydroxyapatitecoated hemiarthroplasties in patients with a fractured neck of femur, but these have shown promising results.7-9 The recent Cochrane review on arthroplasty for fractures of the proximal femur concluded that studies with modern, high ODEP-rated implants are needed to determine whether cemented femoral prostheses are to be preferred or whether hydroxyapatite-coated implants perform equally well.3 This is of particular importance as cementation of the femoral prosthesis has been shown to be associated with increased mortality.10 This stimulated considerable interest in the national press11 and led to a joint statement THE BONE & JOINT JOURNAL

HEMIARTHROPLASTY USING CEMENTED OR UNCEMENTED STEMS OF PROVEN DESIGN

n = 186 no available data at one year

Centre B: Uncemented hemiarthroplasties

Centre A: Cemented hemiarthroplasties

306 uncemented hemiarthroplasties performed between 04/2010 and 04/2012

404 cemented hemiarthroplasties performed between 04/2010 and 04/2012

120 uncemented hemiarthroplasties had available one-year follow-up: cases

404 cemented hemiarthroplasties had available one-year follow-up data: controls

120 uncemented hemiarthroplasties entered study

292 cemented case-control matched to enter study

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Study’s cohort: (n = 412) Uncemented:120 (cases) Cemented: 292 (controls) Fig. 1 Flow diagram illustrating contributions of either centre in the cohort studied.

being issued by the British Orthopaedic Association and the British Hip Society.12 The primary aim of this study was to assess the outcome of patients who had sustained a fractured neck of femur and undergone hemiarthroplasty with one of two stems with the highest ODEP rating (10A). In doing so, we were able to compare the outcome of cemented and uncemented hemiarthroplasty.

Patients and Methods This case-control study is a retrospective analysis of prospectively collected data from two neighbouring centres in the UK, and forms part of the National Hip Fracture Database (NHFD). The NHFD was formed with the collaboration of the British Orthopaedic Association and the British Geriatrics Society. Centre A (John Radcliffe Hospital, Oxford) is a regional, tertiary referral trauma unit with nine consultants, which has, since 2007, routinely used the ETS for treating displaced intra-capsular fractures of the neck of femur. All procedures are performed through the recommended anterolateral approach. Centre B (Royal Berkshire Hospital, Reading) is a high-volume district general hospital, which, since 2010, has routinely used the uncemented, collared, Corail Stem with a Cathcart head. Most procedures were performed through the anterolateral approach, unless an arthroplasty consultant elected to carry out the procedure through their preferred posterior approach. Both centres use Bluespier Theatre Manager (Bluespier International, Droitwich, UK) for recording operations. Both have patients of similar socioeconomic status and share trainees from the same rotation. Furthermore, both have dedicated orthogeriatric input for their patients during the peri- and post-operative periods and aim to operate within the first 36 hours. As NICE suggests, VOL. 97-B, No. 1, JANUARY 2015

a multidisciplinary approach including physiotherapy, occupational therapy assessments and specialist nurse reviews takes place for all patients. Data were obtained for all patients who underwent a hemiarthroplasty in either hospital between April 2010 and April 2012. There were 440 patients from centre A and 306 from centre B. Only patients for whom one-year data were available were included in the study. Patient details recorded included age, gender; abbreviated mental test score (AMTS)13 on admission, place of residence (own home/ residential home/ nursing home/ inpatient in hospital) and mobility status pre-injury (no aid/ one walking aid/ frame/ wheelchair). Anaesthetic data recorded included American Society of Anaesthesiologists (ASA) grade14 and type of anaesthetic given. Surgical data recorded the grade of operating surgeon, and intra- and post-operative complications. Patient cohort. One-year data were available for all 404 patients who had a cemented prosthesis but for only 120 patients who had an uncemented prosthesis (Fig. 1). The outcome of the uncemented cohort has previously been reported.15 The uncemented cohort, being smaller, formed the study group (n = 120) and the cemented cohort, the case-matched controls (n = 292). Consequently, the final number of patients studied was 412. Patients were matched for all factors that have previously been reported to affect morbidity and mortality after hemiarthroplasty.3,4,16,17 These include age; gender; AMTS; residence and mobility pre-injury; grade of surgeon and ASA score (Table I) (p = 0.1 to 0.8). We aimed for as high a ratio (3:1) as possible between controls and cases in order to increase the statistical power of the study. Outcome measures. Primary outcome measures included the rate of complication, re-operation and mortality. The rate of mortality was calculated for two, seven, 30 and 365 days

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G. GRAMMATOPOULOS, H. A. WILSON, B. J. L. KENDRICK, E. C. PULFORD, J. LIPPETT, M. DEAKIN, A. J. ANDRADE, G. KAMBOUROGLOU

Table I. Patient demographics Factor

Cemented (n = 292)

Uncemented (n = 120)

p-value*

Age (yrs, mean; SD) Gender

82.1 (7.8)

83.4 (7.1)

0.7 0.8

96 196 8.5 (2.8)

41 79 8.3 (2.7)

1 2 3 4

5 96 161 30

3 46 58 13

No aids One aid Two aids Wheelchair

148 75 63 4

73 29 17 1

Own home Residential care Nursing home Hospital

260 14 13 5

103 3 8 6

Consultant Registrar

128 164

47 73

Male Female AMTS (mean; SD) ASA

0.1 0.7

Mobility

0.33

Residence

0.15

Surgeon’s grade

0.38

*Mann–Whitney U/Kruskal–Wallis for scale date and Chi-squared or Fisher’s exact test for categorical data ASA, American Society of Anaesthesiologists

post-operatively. A secondary measure was the number of patients who had lived at home prior to fracture and returned to their own home directly from the hospital (home-to-home). Data validity. In order to test for any errors of data entry, we randomly selected 80 patients, including all those who had been reported to have had a complication, and reviewed their notes. There were no errors in data entry for any of the patients from either centre. Statistical analysis. All statistical analyses were performed using PASW statistics (version 18, IBM, New York). Nonparametric tests (Mann–Whitney U, Kruskal–Wallis) were used for continuous data and Chi-squared or Fisher’s exact tests were used for cross-tabulated data. A multivariate linear regression analysis was performed in order to assess if any of these factors had an effect on one-year survival. Factors included in the analysis included gender; ASA; residential status; mobility pre-injury; grade of surgeon, implant; whether they were home-to-home discharges; complications or re-operation (categorical data) and age and AMTS (scale data). A p-value ≤ 0.05 was considered significant.

Results The overall rate of complications was 7.8%, the most common being infection (n = 15, 3.6%) followed by intraoperative fracture of the calcar (n = 13, 3.2%) which required wiring at the time of the index hemiarthoplasty; none of the patients that sustained an intra-operative fracture required any further treatment. A total of 20 hemi-

arthroplasties required further surgery (4.9%). The two-, seven-, 30- and 365- day mortality rates were 1.5%, 3.6%, 9.5% and 26% respectively. As previously reported,3,4,16,17 older age at presentation (p < 0.001), male gender (p = 0.02), higher ASA (p < 0.001), low AMTS (p < 0.001), not living at home (p < 0.001) and poor pre-injury mobility (p < 0.001) were associated with an increased 365-day mortality. However, the grade of operating surgeon was not (p = 0.8) (Table II). Most patients needed an intermediate care package on discharge from hospital; 39% (n = 143) of patients were home-to-home discharges. A higher proportion of complications was seen in the uncemented (n = 16, 13.3%) than in the cemented group (n = 16, 5.5%; p = 0.007). Most complications in the uncemented group (n = 12) were due to a split in the calcar which required wiring and did not affect outcome.15 Most complications in the cemented group were due to infection (n = 13). There was no statistical difference in the rate of reoperation between the cemented (5%) and uncemented (3%) groups (p = 0.36). Of the 16 re-operations in the cemented group, 11 were washouts with retention of the implant, one was an excision arthroplasty, one a revision ETS, two were closed manipulations under anaesthesia for dislocation and one was an open reduction and internal fixation of a Vancouver C peri-prosthetic fracture.18 Re-operations in the uncemented group included one washout, one excision arthroplasty and two revisions to a total hip arthroplasty with the introduction of an acetabular THE BONE & JOINT JOURNAL

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Table II. Mortality rates at one year for the different factors that were used to case-control match the cohort Factor

One-year mortality (%)

Age (yrs)

p-value* 0.003

< 85 ≥ 85

20.8 34.1

Male Female

33.6 22.5

Hemiarthroplasty using cemented or uncemented stems of proven design: a comparative study.

National Institute of Clinical Excellence guidelines state that cemented stems with an Orthopaedic Data Evaluation Panel (ODEP) rating of > 3B should ...
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