Cemented versus uncemented arthroplasty in patients with a displaced fracture of the femoral neck

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1 C. Inngul, R. Blomfeldt, S. Ponzer, A. Enocson From Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden HIP Cemented versus uncemented arthroplasty in patients with a displaced fracture of the femoral neck A RANDOMISED CONTROLLED TRIAL The aim of this randomised controlled study was to compare functional and radiological outcomes between modern cemented and uncemented hydroxyapatite coated stems after one year in patients treated surgically for a fracture of the femoral neck. A total of 141 patients aged > 65 years were included. Patients were randomised to be treated with a cemented Exeter stem or an uncemented Bimetric stem. The patients were reviewed at four and 12 months. The cemented group performed better than the uncemented group for the Harris hip score (78 vs 70.7, p = 0.004) at four months and for the Short Musculoskeletal Function Assesment Questionnaire dysfunction score at four (29.8 vs 39.2, p = 0.007) and 12 months (22.3 vs 34.9, p = 0.001). The mean EQ-5D index score was better in the cemented group at four (0.68 vs 0.53, p = 0.001) and 12 months (0.75 vs 0.58, p = < 0.001) follow-up. There were nine intra-operative fractures in the uncemented group and none in the cemented group. In conclusion, our data do not support the use of an uncemented hydroxyapatite coated stem for the treatment of displaced fractures of the femoral neck in the elderly. Cite this article: Bone Joint J 2015;97-B: C. Inngul, MD, PhD, Orthopaedic Surgeon, R. Blomfeldt, MD, PhD, Orthopaedic Surgeon, S. Ponzer, MD, Professor, Orthopaedic Surgeon, A. Enocson, MD, Associate Professor, Orthopaedic Surgeon, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden. Correspondence should be sent to Dr C. Inngul; christian.inngul@sodersjukhus et.se 2015 The British Editorial Society of Bone & Joint Surgery doi: / x.97b $2.00 Bone Joint J 2015;97-B: Received 8 April 2015; Accepted after revision 9 July 2015 The treatment of displaced fractures of the femoral neck with an arthroplasty is now standard practice. 1 Hemiarthroplasty (HA) yields good results particuarly with regards to improved function, relief of pain and return to independent living in elderly patients who have lower functional demands. 2 Total hip arthroplasties (THAs) generate a better functional outcome at the cost of increased intra-operative blood loss, greater expense and longer operating time. 3 Therefore, THAs are frequently used in younger patients who have higher functional demands. Although cemented fixation of the femoral component has been the standard treatment for patients with a fracture, there are reports that the process of cementation increases the risk of cardiopulmonary events owing to fat embolisation from the femoral canal. 4 The question then is whether these complications could be avoided by using cementless fixation. In the 2010 Cochrane review of arthroplasties 5 (with and without cement) for the treatment of fractures of the femoral neck, it was concluded that cemented fixation led to less pain and better mobility one year after surgery, but with no differences in the rate of complications or mortality. However, the authors also reported that they had reviewed mainly old prothesetic designs, both uncemented and cemented, and that there was a need for further studies which should include modern prostheses. The use of uncemented components is known to increase the risk of periprosthetic fracture, both intra- and post-operatively, and recent data from the Norwegian and Swedish national hip arthroplasty registries showed a greater risk of re-operations for uncemented HAs in elderly patients with a fracture of the hip. 6 The aim of this study was to compare the functional and radiological outcomes of an uncemented hydroxyapatite-coated stem with a cemented stem, in patients undergoing surgery for a displaced fracture of the femoral neck. Patients and Methods Between October 2009 and April 2013, 964 patients with an acute, displaced (Garden grade 3 or 4) 7 fracture of the femoral neck following low-energy trauma presented at our institution. Of these patients, 141 were included in this study. Inclusion criteria were age > 65 years, absence of severe cognitive dysfunction ( three correct answers in the Short Portable Mental Status Questionnaire), 8 absence of drug or alcohol abuse, non-institutionalised independent living status and independent mobility, with or without walking VOL. 97-B, No. 11, NOVEMBER

2 1476 C. INNGUL, R. BLOMFELDT, S. PONZER, A. ENOCSON Table I. Baseline data for all patients included in the study (n = 141) Cemented stem (n = 67) Uncemented stem (n = 74) Mean age (yrs) (range) 81.2 (65 to 96) 81.3 (66 to 93) Mean cognitive function (SPMSQ) (range) 9.3 (5 to 10) 9.0 (6 to 10) Female, n (%) 46 (69) 53 (72) ASA class 1 or 2, n (%) 35 (52) 32 (43) Mobility: no walking aid or just one stick, n (%) 56 (84) 57 (77) ADL n in Katz et al 10 group A, n (%) 63 (94) 66 (89) HA, n (%) 39 (58) 44 (60) THA, n (%) 28 (42) 30 (41) Katz et al 10 group A, totally independent in all activites of daily living (ADL) SPMSQ, Short Portable Mental Status Questionnaire; ASA, American Society of Anesthesiologists; HA, hemiarthroplasty; THA, total hip arthroplasty aids. Patients who sustained a fracture > 48 hours before admission and those with rheumatoid arthritis and symptomatic osteoarthritis were excluded. After anaesthetic assessment, the patients were randomised using sealed, numbered, opaque envelopes for treatment either with a cemented or an uncemented stem. Patients aged between 65 and 79 years were allocated to treatment with either a cemented THA or a reverse hybrid THA. Patients aged > 80 years were allocated to treatment with either a cemented or an uncemented unipolar HA. The study was originally designed as two independent projects examining HAs and THAs separately. Owing to slow recruitment, a decision was made in November 2012 to pool the two studies. Surgical intervention. All operations were performed by consultant orthopaedic surgeons experienced in the use of cemented and uncemented stems. Patients were operated upon in a lateral decubitus position via a direct lateral approach. 9 Patients randomised to the cemented group received a cemented Exeter stem (Stryker Howmedica, Kalamazoo, Michigan) with either a unipolar head (HA patients) or a 32 mm head and a cemented cross-linked polyethylene (XLPE) Marathon cup (THA patients) (DePuy/Johnson & Johnson, Warsaw, Indiana). In the uncemented group, a hydroxyapatite coated Bimetric stem (Biomet, Warsaw, Indiana) with either a unipolar head (HA patients) or a 32 mm head and a cemented XLPE Marathon cup (THA patients) was used. With all cemented implants gentamicin-loaded Optipac (Biomet) bone cement was used. Spinal anaesthesia was the preferred method of anaesthesia and all patients received prophylactic antibiotics (Cloxacillin 2 g intravenously) 30 to 60 minutes pre-operatively, and three and six hours later. On the evening after the operation all patients received low molecular heparin (4500 IU Tinzaparin), which was continued for 30 days. Patients in both groups were allowed to bear weight as tolerated, after the operation. Primary assesment and follow-up. After giving consent, the patients were interviewed by a research nurse regarding living conditions and activities of daily living (ADL). 10 They were asked to complete a health-related quality of life (HRQoL) questionnaire (EQ-5D) 11 and the Short Musculoskeletal Function Assesment Questionnaire (SMFA) 12 as recalled during the last week before the fracture. The patients were reviewed at four and 12 months after surgery with clinical assesment using the Harris hip score (HHS), 13 SMFA, EQ-5D and with radiological examinations. The SMFA contains two parts: the Dysfunction index and the Bother index. The Dysfunction index is intended to interpret the patient`s perception of difficulties and actual difficulties they encounter in performing certain functions. The Bother index is used to interpret how much the patient is bothered by problems they encounter in different areas of daily life. If the patients declined a follow-up visit, a home visit was offered (four months n = 2, 12 months n = 5). Bleeding and operating time were recorded as well as all general and hip related adverse events after the surgery. All adverse events during the first three weeks were considered to be related to the surgery. Radiological outcome. An anteroposterior (AP) view of the pelvis and AP and lateral views of the hip were taken preand post-operatively, as well as at four and 12 months and were reviewed by an independent radiologist. All femurs were classified pre-operatively as type A, B or C using the Dorr classification. 14 Post-operative heterotopic ossification was graded as described by Brooker et al 15 and the acetabular erosion, in patients with HAs, was graded using the system described by Baker et al. 16 Statistical methods. After joining the two original studies, a power analysis indicated that 140 patients, with an estimated 10% one-year mortality and rate of drop out, would make it possible to detect a five-point difference in the HHS with 80% power and a 5% level of significance. All patients were analysed according to the intention-to-treat principle. The Mann Whitney U test was used for nonparametric data. Nominal variables were tested with the Fisher s exact test. Wilcoxon s signed-rank test was used to compare data at the four- and 12-month follow-ups. All tests were two-sided. The results were considered significant at a p-value of < The statistical software used was IBM SPSS Statistics version 20 and IBM SPSS Sample Power version 3 (SPSS Inc., Chicago, Illinois). The study and the change in the study protocol were approved by the local ethics committee (2009/1188-3/1 THE BONE & JOINT JOURNAL

3 CEMENTED VERSUS UNCEMENTED ARTHROPLASTY IN PATIENTS WITH A DISPLACED FRACTURE OF THE FEMORAL NECK 1477 Table II. Adverse events Cemented group (n = 67) Uncemented group (n = 74) Intra-operative femoral fracture 0 9 * Intra-operative fracture of the tip of the greater trochanter 4 4 Re-operation due to dislocation 1 0 Re-operation due to deep infection 0 1 Superficial wound infection 4 9 Urinary tract infection 9 7 Pneumonia 1 2 Acute myocardial infarction 0 1 Acute cardiac failure 0 1 Acute renal failure 0 1 Death within 24 hours post-operatively 1 0 * Eight cases were discovered during surgery and one case was first discovered at the four-month follow-up Table III. Functional outcome by the Harris hip score (HHS) and Short Musculoskeletal Function Assesment Questionnaire (SMFA). Data are presented as means with standard deviation (SD) Cemented group Uncemented group p-value HHS total (SD) (4 mths, n = 127) 78 (14) 70.7 (14.6) HHS total (SD) (12 mths, n = 123) 82.3 (13.1) 78.6 (17.1) 0,093 HHS pain subscore (SD) (4 mths, n = 127) 39.6 (8.2) 37.2 (9.1) HHS pain subscore (SD) (12 mths, n = 123) 40.7 (8.8) 38.9 (9) SMFA dysfunction score pre-operatively (SD) (n = 138) 17.9 (13.8) 21.2 (14.3) SMFA bother score pre-operatively (SD) (n = 133) 12.7 (14) 12,5 (11.3) SMFA dysfunction score (SD) (4 mths, n = 125) 29.8 (17.5) 39,2 (19.6) SMFA bother score (SD) (4 mths, n = 117) 26.9 (19.4) 32,2 (19.9) SMFA dysfunction score (SD) (12 mths, n = 118) 22.3 (16.3) 34.9 (22.2) SMFA bother score (SD) (12 mths, n = 116) 18.6 (16.8) 29 (21.1) and 2013/412-32) and is registered at (NCT ). Results A total of 141 patients were included in the study, 67 in the cemented and 74 in the uncemented group. Baseline data are presented in Table I. The mean age of the patients was 81.3 years (65 to 96), and 99 (70.2%) were women. One HA patient randomised to the cemented group suffered from acute pulmonary oedema immediately before the operation and was treated by closed reduction and internal fixation with two cannulated screws. Mortality. One patient in the cemented HA group suffered acute severe hypotension during cementation of the stem and died within two hours of the operation because of cardiac failure. No other deaths occurred within 48 hours after the operation. A total of five patients (3.5%) had died four months post-operatively, and 11 (7.8%) at 12 months. There was no difference in the rate of mortality at four months between the cemented (four of 67) and the uncemented group (one of 74; p = 0.2). Nor was there any difference in the rate of mortality at 12 months between the cemented (seven of 67) and the uncemented group (four of 74; p = 0.4). Surgical outcome. The mean intra-operative blood loss was 297 ml (standard deviation (SD) 202) in the cemented, and 341 ml (SD 259) in the uncemented group (p = 0.5). The mean operating time was 82 minutes (SD 27) for the cemented and 80 minutes (SD 18) for the uncemented group (p = 0.8). Surgical adverse events. Eight patients in the uncemented group suffered an intra-operative periprosthetic fracture. After fixation with cerclage wires, five had sufficient stability to proceed with the operation as planned, whereas three were converted to cemented stems. One patient who underwent uncemented THA suffered an intra-operative periprosthetic fracture that was not detected until the fourmonth follow-up, when the radiographs were re-evaluated. The fracture was classified as a Vancouver A L and united unremarkably following conservative treatment. 17 Four patients in both groups had an intra-operative fracture of the tip of the greater trochanter but none required further treatment (Table II). Functional outcome HHS. At four months, the mean total HHS was significantly better in the cemented group than in the uncemented group (p = 0.004), however, there was no statistical difference at the 12-month follow-up (Table III). SMFA. The mean SMFA showed a significantly better dysfunction score at four months (p = 0.007) and 12 months (p = 0.001) in the cemented group, and a better bother score at 12 months (p = 0.007) (Table III). HRQoL. The mean EQ-5D index score for all patients was consistently more favourable in the cemented group, with VOL. 97-B, No. 11, NOVEMBER 2015

4 1478 C. INNGUL, R. BLOMFELDT, S. PONZER, A. ENOCSON Table IV. Type of femur, acetabular erosion and heterotopic ossification Cemented group Uncemented group Type of femur pre-operatively Dorr type A 0/67 * 4/74 * Dorr type B 26/67 * 52/74 * Dorr type C 41/67 * 18/74 * Acetabular erosion (only HAs) 4-month follow-up (Grade 1) 4/28 * 4/39 * 12-month follow-up (Grade 1) 5/26 * 8/35 * Heterotopic ossification 4-month follow-up Grade 1 21/56* 30/67 * Grade 2 13/56 * 13/67 * Grade 3 2/56 * 1/67 * 12-month follow-up Grade 1 22/53 * 27/62 * Grade 2 13/53 * 14/62 * Grade 3 2/53 * 4/62 * Grade 4 1/53 * 0/62 * * Available radiographs EQ-5D index score all patients Cemented stem Uncemented stem 0 Pre-fracture 4 mths 12 mths (p = 0.5) (p = 0.001) (p < 0.001) Fig. 1a EQ-5D index score HA patients Cemented stem Uncemented stem 0 Pre-fracture 4 mths (p = 0.8) (p = 0.004) Fig. 1b 12 mths (p < 0.001) EQ-5D index score THA patients Pre-fracture (p = 0.5) Cemented stem Uncemented stem 4 mths (p = 0.09) Fig. 1c 12 mths (p = 0.01) Graphs showing the mean EQ-5D index score for a) all patients; b) those treated by hemiarthroplasty (HA) and c) those treated by total hip arthroplasty (THA). significant differences at four and 12 months (Fig. 1a). When analysing patients who underwent HA and THA separately, a difference was found in favour of the cemented patients with significant results at both periods of time for the HA patients and at 12 months for the THA patients (Figs 1b and 1c). Radiological outcome. Radiographs were available for 123 patients (87.2%) at four months post-operatively, and for 115 patients (81.6%) 12 months post-operatively (Table IV). Discussion In this study, we used modern cementing techniques and a modern hydroxyapatite coated uncemented stem, in order to compare the functional and radiological outcomes in patients undergoing surgical treatment for a displaced fracture of the femoral neck. The main findings were an increased rate of intra-operative complications and inferior functional results associated with the use of an uncemented stem. Similar results were reported in a randomised controlled trail (RCT) with a two-year follow-up by Taylor et al. 18 They found better results in the Oxford hip score for the cemented implant with a statistically significant difference at the six-week follow-up. Furthermore, they found more intra-operative fractures in the uncemented group compared with the cemented (six of 80 vs zero of 80), highlighting the risk associated with introducing a press-fit stem into osteoporotic bone. In contrast, in a one year follow-up of a RCT including 130 patients who were treated with a HA, DeAngelis et al 19 reported, that no difference in stem spe- THE BONE & JOINT JOURNAL

5 CEMENTED VERSUS UNCEMENTED ARTHROPLASTY IN PATIENTS WITH A DISPLACED FRACTURE OF THE FEMORAL NECK 1479 cific or general complications could be detected. Nor could they find any difference between the ADL-based score, intra-operative blood loss or operating time. Late post-operative periprosthetic fractures and revison, owing to failure of osseointegration, are also risk factors when using uncemented stems in the elderly. 20 There is evidence that coating titanium stems with hydroxyapatite improves bone ongrowth, even in osteoporotic bone. Sköldenberg et al 21 demonstrated good fixation, after three months, in patients with femoral neck fractures using a stem design similar to the one used in our study. In addition, Schewelov et al 22 reported promising results from a radiostereometric analysis in 38 patients treated for a fracture of the hip using an hydroxyapatite-coated stem. After initial subsidence, the stem seems to stabilise within about three months. However, Figved et al 23 published 12-month results from a RCT comparing cemented HAs and uncemented hydoxyapatite coated HAs. They found no difference between the groups in the HHS or EQ-5D index score at four or 12 months, and no difference in the rate of intraoperative fracture, but, in contrast to our findings, the operating time and the intra-operative blood loss was significantly less in the uncemented group. For the late periprosthetic fractures, there is evidence from different national joint registries 6,24 and one mid-term follow-up (five years) of a RCT, 25 that uncemented stems constitute a risk factor for such a complication. Parker et al 26 reported a RCT in which cemented Thompson protheses were compared with uncemented Austin-Moore protheses. During a follow-up period which ranged between two and five years, there was no significant difference between the groups regarding the rate of revision owing to periprosthetic fracture. In our study no revision was required because of a late periprosthetic fracture or loose implant, but a one-year follow-up may not be sufficient to detect late fractures. In systematic review of relevant RCTs undertaken by Azegami et al 27 in 2011, the authors concluded that cemented implants were superior as regards to mobility scores and pain relief. However, this review included only one study which involved a modern hydroxyapatite coated stem. 23 In 2014 in a meta analysis, Ning et al 28 could not demonstrate, any significant difference regarding residual pain or complications between those treated with cemented or uncemented HAs. Their analyis included four studies 19,23,29,30 comparing modern hydroxyapatite coated uncemented HAs with cemented HAs. One of the theoretical advantages of using an uncemented HA in patients who have sustained a fracture is to avoid immediate fatal complications related to the introduction of cement known as the cement implantation syndrome. 4 This theory is supported by findings from the Australian National Joint Replacement Registry, 31 where it was found that there was an increased rate of mortality on the first post-operative day for cemented implants and an increased rate of mortality for those with uncemented implants after one week, one month and one year following surgery. Interestingly, the authors were not able to show any significant difference in the rates of mortality throughout the follow-up period of one year when only modular uncemented and cemented implants were compared, and a modular implant is more likely to be of a modern design. A major weakness of registry data is a selection bias, as the choice of treatment is influenced by the age, gender and comorbidities of the patient and it can be expected that uncemented implants would have been chosen for the elderly more frail patients, in order to avoid the cement implantation syndrome. In our study, we had one death on the first post-operative day related to this syndrome, with no further differences in the rates of mortality. None of the RCTs have shown a difference in the rate of mortality, but a RCT is probably not the right method to compare the rates of mortality owing to the limited number of patients included in the trials. We also found that there were no differences between the groups with regard to the formation of HO or to the development of acetabular erosion. It would appear that acetabular erosion plays a minor role in the short- and mid-term functional outcomes. 32,33 The limitations of this study include the small number of patients, a relatively short follow-up, the loss of some patients to follow-up and the lack of blinding of the assessors of outcome. The fact that this study was originally designed as two individual studies is also a weakness, as it resulted in a slightly uneven distribution of the number of patients between the groups. However, this should have been addressed by the statistical methods which were used. In conclusion, our data do not support the use of an uncemented hydroxyapatite coated stem for the treatment of displaced fractures of the femoral neck. We found an increased rate of intra-operative complications and inferior functional results, over the period of one year, compared with a modern cemented implant and without producing any benefits such as a shorter operating time or reduced blood loss. Supplementary material A flow chart of all the patients is available alongside the online version of this article at Author contributions: C. Inngul: Study design and planning, performed surgery, data collection and analysis and writing of the paper. R. Blomfeldt: Performed surgery, data collection and analysis and writing of the paper. S. Ponzer: Study design and planning, data collection and analysis and writing of the paper. A. Enocson: Study design and planning, performed surgery, data collection and analysis and writing of the paper. We thank P. Lindhè, MD from the department of radiology at Södersjukhuset for reviewing all radiographs. No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. This article was primary edited by S. P. F. Hughes and first proof edited by J. Scott. VOL. 97-B, No. 11, NOVEMBER 2015

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