Cemented Calcar Replacement versus Long Stem Cemented Hemiarthroplasty in Unstable Intertrochanteric Fractures in Octogenarians

Abstract

Objective The aim of the present study was to compare functional results after Cemented Calcar replacement vis-a-vis Long stem Cemented hemiarthroplasty in patients aged more than 80 years with unstable intertrochanteric fractures.

Methods The present prospective, randomized trial included 140 patients with AO/OTA type 31-A2, A3 intertrochanteric femur fracture, randomized into 2 treatment groups and followed-up for a minimum of 2 years. Sixty-seven patients in group A were treated with a cemented calcar replacing prosthesis, and 65 patients in group B were treated with a cemented long stem femoral stem prosthesis. The primary end points were hip functions at 2 years. The secondary end points were the complications encountered, mortality, surgical time, reoperation, blood loss, and activities of daily living.

Results There were no major differences between the groups in terms of hip function, quality of life (health related), reoperation, mortality, and blood loss. However, the function in hip joint and activities of daily living deteriorated in both groups in comparison with prefracture levels.

Conclusion In octogenarians with an unstable intertrochanteric fracture, cemented calcar replacing prosthesis has similar clinical results in comparison with long stem cemented hemiarthroplasty. Hemiarthroplasty with either implant is a good option in this subset of patients. Level of evidence: I

Keywords

hemiarthroplasty - hip fractures - arthroplasty, replacement, hip - hip prosthesis

Introduction

The elderly population with osteoporosis has a high incidence of implant failure and poor functional results in terms of limb shortening with external rotational deformity following osteosynthesis with dynamic hip screw or intramedullary hip screw fixation in case of unstable intertrochanteric fractures.[1] These fears restrict weight bearing, resulting in prolonged bed rest and subsequent morbidity and mortality.[2] [3] The requirement of a second surgery in these cases is an important consideration before choosing the appropriate procedure and implant.

Hemiarthroplasty can be posed as a solution to these problems of osteosynthesis. It allows for immediate weight bearing and allays the fears of nonunion or malunion at the fracture site.[4] Few authors suggest reconstruction of the femoral calcar to avoid early subsidence of the implant and maintain the initial stability.[5] [6] However, calcar reconstruction increases the complexity of the procedure and, therefore, the overall complication rates.[7] [8] Hence, calcar replacement is an option to avoid complications such as calcar nonunion, especially in octogenarians.[9]

Zha et al.,[10] in their retrospective study, advocate the use of distal fixing long cementless stem to decrease the surgical complications. However, due to osteoporosis and wide femoral canals, there are high chances of implant failure with uncemented stems in the elderly population.[11] There are studies that reported complications with the use of cement in hemiarthroplasty,[12] [13] but others have reported good outcomes.[14] [15]

We are not aware of any study comparing the results of treatment with cemented calcar replacing with long stem cemented hemiarthroplasty. We hypothesized that calcar replacing cemented hemiarthroplasty would be associated with better hip function and better health-related quality of life in comparison with long stem cemented hemiarthroplasty in cognitively intact octogenarians with an unstable intertrochanteric fracture.

Materials and Methods

Study Design

The present single center, prospective randomized controlled trail was conducted according to the guidelines of good practice and the Consolidated Standards of Reporting Trials (CONSORT) statement.[16] Between March 2013 and November 2018, 140 cases with unstable intertrochanteric femoral fractures (AO/OTA type 31-A2, A3) were enrolled in the study, which was approved by the institutional review board (AIMC/CT02092013). Informed consent was taken from all the participants in the trial.

Participants

All patients with unstable intertrochanteric fracture were screened for participation in the study. The inclusion criteria were unstable intertrochanteric femoral fractures (AO/OTA type 31-A2, A3), age ≥ 80 years old, independent walking with or without help of walking aid prior to the injury and intact cognitive function with a short portable mental status questionnaire (SPMSQ) score of 8 to 10 points.[17] Patients with pathological fracture, rheumatoid arthritis in the involved hip, polytraumatic injuries, simultaneous fractures of the ipsilateral extremity and patients who refused participation and were unfit for operation were excluded from the study ([Fig. 1]).

Fig. 1 CONSORT flow diagram of the participants in the study. The surgeon chooses to perform total hip arthroplasty in seven cases due to acetabular erosions encountered during surgery. One patient was taken up for internal fixation due to suspected urinary tract infection.

Randomization and Blinding

The patients were block randomized with a block size of 10 in a ratio of 1:1 to undergo an operative procedure with either calcar replacing or long stem femoral stem hemiarthroplasty. The envelopes were sealed and stratified by gender to ensure similar gender distribution in both groups. The patients were blinded to the treatment while the surgeon and three nursing assistants were not. The nursing assistants were instructed not to reveal the allocation to the patients. The postoperative care protocol did not differ between the two groups. The patients were not shown their radiographs and were asked whether they knew about the treatment at the time of the last follow-up.

Data Collection

Three nursing assistants involved in the research interviewed the patients and obtained baseline data of the patients 1 week prior to the fracture. The patients were followed-up at 4 months, 1 year and 2 years. The functional outcome was self-reported by the patients.

Operative Technique

Cemented Calcar Replacement Hemiarthroplasty

The injured hip was approached posterolaterally under spinal anesthesia. We used different lengths of calcar extensions on a case-to-case basis in order to provide a stable platform for the hip prosthesis to rest. The length of the stem varied between 170 and 220 mm with increments of 15 mm. The fractured greater trochanter was attached with help of #5 Ethibond (Ethicon, Somerville, NJ, USA) cerclage wires to the lateral aspect of the femoral stem ([Fig. 2a-b]).

Fig. 2 (A-B) Radiographic image showing unstable intertrochanteric fracture treated with calcar replacing hemiarthroplasty and greater trochanter attached to the proximal and lateral aspect for femur.

Cemented Long Stem Hemiarthroplasty

The surgical approach was similar as that of in cases of calcar replacement. The fractured fragments were removed from the proximal femur. The femoral canal was prepared using broach and a trial modular femoral stem was inserted followed by hip reduction. Preoperative planning helped in deciding intraoperatively the appropriate length of the stem. Bone cement was used to build up the posteromedial defect in proximal femur ([Fig. 3a]). The length of the stem varied between 170 and 300 mm. The stability of the prosthetic hip joint was ascertained and, subsequently, an appropriately sized head was used.

Fig. 3 (A-C) Build-up of calcar with cement in a case of unstable fracture treated with long stem bipolar hemiarthroplasty.

Postoperative Protocol

The patients were mobilized and allowed to bear weight as tolerated with the help of crutches. All patients in both groups were administered aspirin 75 mg daily starting on the 1^st postoperative day and was continued until discharge from the hospital at the 10^th postoperative day. The radiographic evaluation was done by an independent observer (Lakhani AK) ([Fig. 3 b-c]).

Primary End Points

The primary end points were the hip function as assessed by the Harris Hip Score (HHS).[18] The HHS is a validated tool for reporting outcomes in pertrochanteric fractures.[19] Harris hip scores were graded < 70 as poor, 70 to 79 as fair, 80 to 89 as good, and 90 to 100 as excellent.

Secondary End Points

The secondary end points were hip function as assessed by the Barthel Index (BI)[20] and the EuroQol-5 (EQ-5D).[21] The BI includes 10 activities of daily living such as feeding, grooming, bathing, dressing, bowel care, bladder care, toilet use, ambulation, transfers, and stair climbing. The total range of the BI is from zero to 20. The EQ-5D is a generic instrument to measure health-related quality of life. Other parameters studied were hip-related complications, pain in the involved hip, surgical time, intraoperative blood loss, mortality, and ability to regain previous walking function.

Sample Size

The sample calculation was based on two variables: the HHS and the EQ-5D. Based on a previous study,[22] we assumed that a difference of 10 ± 15 (mean ± standard deviation [SD]) would be the smallest clinically relevant change in the HHS. So, to achieve a power of 80%, a minimum of 60 patients should be enrolled in the study. This calculation also allowed to prove noninferiority in the case of the EQ-5D, with an assumption of mean values of 0.73 ± 0.18 (0.1 as limit of noninferiority). The statistical significance level was set at 0.025 to include multiplicity encountered by the calculation of 2 sample sizes. The final study included 140 patients, with 70 patients in each group to account for attrition.

Statistical Method

The analyses of outcomes were done on the intent to treat principle, and all patients were analyzed in the group allocated regardless of the treatment administered. Analysis according to protocol was also performed. The chi-squared test was used to test correlations in ordinal data, and the student t-test was used to compare the HHS, the BI, and the EQ-5D between the two groups. Analysis of covariance (ANCOVA) of the primary end points was used to decrease variance with inclusion of exposure variables and stratification. Statistical analysis was performed using IBM SPPS Statistics for Windows, Version 22 (IBM Corp., Armonk, NY, USA).

Results

A total of 432 patients were screened for eligibility, and 292 were excluded for not meeting the inclusion criteria. A total of 140 patients were randomized into 2 groups with 70 cases in each group. In one group, the patients were treated with calcar replacing cemented hemiarthroplasty (calcar replacement stem; Xlo, New Delhi, India); in the other group, the patients were treated with long stem cemented hemiarthroplasty (Xlo, New Delhi, India).

All cases were operated on by a single surgeon (Bansal D.) within an interval of 4 days after the initial injury following management of comorbidities. Both groups were comparable in terms of age, gender, and osteoporosis index as defined by Singh et al.[23] ([Table 1]).

Table 1

	Group A (n = 70) *	Group B (n = 70)
Age (years old)#	83 ± 3.7	82 ± 3.4
Gender
Male	48	48
Female	12	12
Body Mass Index (kg/m2)#	21 ± 3.2	22 ± 2.4
Singh osteoporosis Index	2.7 ± 0.6	2.6 ± 0.7
Charnley functional classification (number of patients)
A	58	56
B	7	11
C	5	3
ASA classification (number of patients)
1–2	43	38
3–4	27	32

Primary End Points

In the intent to treat analysis, the functional outcome scales (HHS, EQ-5D, and BI) deteriorated over time and revealed no significant difference between cemented calcar replacing and long stem hemiarthroplasty ([Table 2]; [Figs. 4] and [5]). The findings remained similar after per protocol and ANCOVA analysis of end points. The American Society of Anesthesiologists (ASA) classification at baseline and higher walking ability prior to injury did not affected the primary end point.

Fig. 4 Line graph showing mean Harris Hip Score during the study period.

Fig. 5 Line graph showing mean EQ-5D index scores (a health-related quality of life measure) during the study period.

Table 2

	Intent to Treat			Per Protocol
Outcome measure	Calcar replacement hemiarthroplasty (n = 70)	Long stem hemiarthroplasty (n = 70)	Mean difference or relative risk (95%CI)#	Calcar replacement hemiarthroplasty (n = 67)	Long stem hemiarthroplasty (n = 65)	Mean difference or relative risk (95%CI)#
Harris Hip Score
Baseline	83.4 ± 8.6[*] (n = 69)	82.4 ± 11.2 (n = 70)	1.0 (−5.7373–3.7373)	83.4 ± 8.6 (n = 69)	82.4 ± 11.2 (n = 65)	1.0 (−5.7373–3.7373)
4 months	80.4 ± 9.4 (n = 64)	77.5 ± 8.1 (n = 62)	2.9 (7.0953–1.2953)	80.4 ± 9.4 (n = 64)	77.5 ± 8.3 (n = 58)	3.9 (8.0953–1.2953)
12 months	78.4 ± 8.7 (n = 59)	75.4 ± 9.6 (n = 60)	3.0 (−7.3414–1.3414)	78.4 ± 8.7 (n = 59)	75.4 ± 9.6 (n = 55)	3.0 (−7.3414–1.3414)
24 months	74.5 ± 9.6 (n = 53)	73.8 ± 7.8 (n = 55)	0.7 (−6.78–2.348)	74.5 ± 9.6 (n = 53)	73.5 ± 7.8 (n = 51)	1.0 (−6.78–2.348)
Barthel Index
Baseline	18 (51%)	17 (49%)	1.04 (0.7888–1.3734)	18 (51%)	17 (49%)	1.04 (0.876–1.4573)
4 months	16 (46%)	16 (46%)	0.9409 (0.6974–1.2695)	16 (46%)	14 (43%)	0.8409 (0.7074–1.256)
12 months	15 (43%)	14 (41%)	1.0238 (0.7416–1.4134)	15 (44%)	13 (42%)	1.0238 (0.7416–1.4134)
24 months	12 (38%)	13 (39%)	1.3214 (0.7653–1.3675)	12 (38%)	11 (36%)	1.1214 (0.8765–1.4675)
EQ-5D
Baseline	0.63 ± 0.29 (n = 69)	0.62 ± 0.31 (n = 70)	0.01 (−0.18–0.02)	0.63 ± 0.29 (n = 69)	0.62 ± 0.31 (n = 65)	0.01 (−0.18–0.02)
4 months	0.63 ± 0.27 (n = 64)	0.62 ± 0.25 (n = 62)	0.01 (−0.06–0.11)	0.63 ± 0.27 (n = 64)	0.59 ± 0.25 (n = 58)	0.04 (−0.08–0.12)
12 months	0.61 ± 0.25 (n = 59)	0.63 ± 0.23 (n = 60)	0.02 (−0.18–0.02)	0.61 ± 0.25 (n = 59)	0.62 ± 0.23 (n = 55)	0.01 (−0.18–0.02)
24 months	0.54 ± 0.26 (n = 53)	0.57 ± 0.30 (n = 55)	0.03 (−0.18–0.02)	0.54 ± 0.26 (n = 53)	0.56 ± 0.30 (n = 51)	0.02 (−0.16–0.01)
Pain Rating Scale
Baseline	0.5 ± 1.3 (n = 69)	0.43 ± 1.7 (n = 70)	0.02 (0.4–0.6)	0.5 ± 1.3 (n = 69)	0.41 ± 1.7 (n = 65)	0.19 (0.3–0.6)
4 months	2.1 ± 1.8 (n = 64)	2.0 ± 1.5 (n = 62)	0.1 (0.4–1)	2.1 ± 1.8 (n = 64)	2.0 ± 1.5 (n = 58)	0.1 (0.4–1)
12 months	1.5 ± 1.6 (n = 59)	1.3 ± 1.2 (n = 60)	0.02 (0.6–0.9)	1.5 ± 1.6 (n = 59)	1.4 ± 1.2 (n = 55)	0.1 (0.6–0.9)
24 months	1.4 ± 1.9 (n = 53)	1.5 ± 1.6 (n = 55)	0.2 (0.8–0.6)	1.5 ± 1.9 (n = 53)	1.2 ± 1.6 (n = 51)	0.3 (0.8–0.6)
Ability to walk with aid
Baseline	33 (94%)	32 (88%)	1.0682 (0.9785–1.1661)	31 (91%)	32 (88%)	1.2422 (0.7895–1.4325)
4 months	27 (78%)	29 (80%)	0.9750 (0.8451–1.1248)	27 (78%)	29 (80%)	0.8897 (0.8456–1.1248)
12 months	30 (85%)	30 (84%)	0.9882 (0.8776–1.1128)	30 (85%)	27 (81%)	0.7654 (0.8965–1.5643)
24 months	28 (79%)	27 (78%)	0.8977 (0.7894–1.2314)	26 (74%)	25 (75%)	0.9875 (0.6754–1.3345)

Secondary End Points

The intraoperative parameters are listed in [Table 3]. There was no significant difference in pain scores and activities of daily living in the two groups. Both parameters deteriorated with time ([Table 2]).

Table 3

Parameter	Calcar replaced (n = 67)	Long Stem (n = 65)	Mean Difference	95%CI	p-value
Operative time (minutes)	109 ± 20[*]	104 ± 23	− 5.000	−15.2166–5.2166	0.3323
Blood loss (ml)	730 ± 112	745 ± 109	15.000	−37.3229–67.3229	0.5692
Blood transfused (units)	2.3 ± 0.6	2.5 ± 0.7	0.200	−0.1091–0.5091	0.2010

The complications encountered in the postoperative period are presented in [Table 4]. There were two cases of hip dislocation in the calcar replacing hemiarthroplasty group A. One patient suffered dislocation while sitting on a traditional woven bed, while another had fallen in the washroom. In both cases, the dislocation was reported after discharge from hospital. Prosthetic hip dislocation was reduced by open reduction in both cases. Hip abduction braces were advised to be worn for 6 weeks. There were no subsequent recurrences.

Table 4

	Calcar replacement (n = 67) group	Long stem (n = 65) group
Immediate postoperative
a. Cardiovascular events	4	2
b. Urinary tract infection	2	0
c. Neurologic complications	0	1
d. Deep vein thrombosis	1	0
e. Respiratory complications	2	3
f. Superficial infection	3	4
g. Deep infection	1	0
h. Mortality in hospital	1	0
i. Nerve injury	0	1
Late postoperative complications
a. Mortality within one year	3	2
b. Mortality after one year	8	6
c. Dislocation	2	0
d. Trochanteric nonunion	0	2

Two patients had trochanteric nonunion in group B ([Fig. 6]), and one of them had symptomatic lurch. The patient who had symptomatic lurch refused any further intervention. Three patients in group A and four patients in group B had superficial infection, which was treated with antibiotics and regular dressings ([Fig. 7]). One patient in group A developed deep seated infection, and debridement was performed, but no organism was obtained on culture sensitivity reports. The patient developed discharging sinus 3 weeks after debridement. He was advised repeat debridement with removal of the prosthesis, but refused any further intervention at our institution.

Fig. 6 Radiographic image showing trochanteric nonunion.

Fig. 7 Clinical Image showing bleb formation in case of superficial infection treated with debridement.

Success of Blinding

The success of blinding was tested in the 105 patients available at the time of the last follow-up, that is, 2 years after the surgical intervention. A total of 28 patients correctly identified their allocation, 24 were did not guess it correctly, and 53 did not know about the allocation ([Table 5]). In the test for blinding, the difference was not significant between the two groups (p = 0.63). Moreover, the difference in the outcomes was not statistically significant between the patients who had correctly guessed the allocation and those did not ([Fig. 8]).

Fig. 8 Test for blinding at the time of last follow up.

Table 5

Actual number of patients underwent allocation
	Calcar replaced (n = 48) hemiarthroplasty	Long stem (n = 57) hemiarthroplasty
In which you were allocated?
Calcar replacing hemiarthroplasty	12 (25%)	16 (28%)
Long stem hemiarthroplasty	13 (27%)	11 (19%)
Don't know	23 (48%)	30 (53%)

Participants Who Refused Participation

There were 89 patients who declined participation in the study; they were similar in terms of gender (p = 0.56), age (p = 0.53), and ASA classification (0.23).

Discussion

Hip fractures are among the most frequent causes of morbidity and mortality in the elderly population.[24] Intertrochanteric fractures account for 50% of all hip fractures. The majority of these fractures is unstable, with loss of posteromedial support and displaced lesser trochanteric fragment.[25] Although surgical techniques and patient care have improved a lot in recent years, the ideal treatment for intertrochanteric fractures is still under debate.[25]

Currently, the treatment options for unstable intertrochanteric fracture are internal fixation or hemiarthroplasty with either cemented or cementless stems. High union rates have been reported with internal fixation of stable intertrochanteric fractures, but failure rates of up to 55% have been recorded in unstable, osteoporotic fracture patients.[26] The poor bone quality in the elderly population does not provide firm purchase in many cases, leading to failure in terms of screw cut-out, varus collapse, and retroversion of femoral head.[27]

Bipolar hemiarthroplasty is proposed as a treatment modality for managing unstable intertrochanteric fractures due to its advantages such as early mobilization, good functional results, and lower implant failure rates. Although uncemented femoral stems have lower chances of cement implantation syndrome, there is always risk of femoral stem loosening with rates varying up to 18%.[28] Cobden et al.[28] reported a higher rate of femoral stem loosening, especially in the elderly population.

Using the HHS, Socci et al.[1] reported good to excellent results in ∼ 80% of the patients; there was no case of dislocation or of loosening. Zha et al.,[10] in their study of patients > 75 years old treated with hemiarthroplasty, reported good results in 83% of the subjects. Many authors believe that following surgery, the patient should be mobilized as early as possible to prevent complications and reduce mortality.[3] [27] Our patients were permitted weight bearing using a walker on day one of the surgery. Our study demonstrated that elderly patients with unstable intertrochanteric fractures treated with either cemented calcar replacement or long stem hemiarthroplasty had successful clinical results. The cost of the implants (calcar replacing or long stem hemiarthroplasty) used in either treatment group are comparable but are more expensive than the implants routinely used in the treatment of unstable intertrochanteric fractures.

To obtain good implant stability, a few authors suggested reconstructing the calcar femorale.[29] [30] [31] However, others argue that calcar replacement with prosthesis augments the deficit in the proximal medial part of the femur. To reconstruct the calcar femorale, it would require further wound exposure for fixation of the lesser trochanteric fragment. An extensive soft tissue stripping and reconstruction technique is likely to result in longer operative time and increased blood loss in already cardiovascularly compromised patients. Abdelkhalek et al.[32] reported an average operative time of 140 minutes using cemented hemiarthroplasty with reconstruction of the calcar femorale in elderly patients. In contrast, a shorter operative time of 109 ± 20 minutes in calcar replacement and of 104 ± 23 minutes in the long stem group was noted in our study. However, there was a higher number of cases of limb length discrepancy noted with use of calcar replacing prosthesis than with calcar reconstruction. Knutson et al.[33] reported that a limb length discrepancy < 1 cm does not lead to any major function disability. In our study, the limb length discrepancy was between 4 and 8 mm, so the patients had good functional outcomes.

Strength of the Study

The strengths of the present study were its prospective nature, blinding, randomization, inclusion of intention treat and per protocol analyses, randomization stratified by gender to attain equal gender distribution in both groups, and adherence to a predefined hypothesis and outcome measurements assessment. Other significant strength factors were inclusion of methods like check for success of blinding and analysis of patients who had declined to participate in the study. To the best of our knowledge, this is the first randomized controlled trail (RCT) comparing calcar replacing with long stem hemiarthroplasty.

Nonetheless, the present study has a few limitations. First, it did not include a large number of patients. Second, the follow-up of patients was relatively short; therefore, long-term complications such as acetabular erosion, stem failure, late dislocation or infection could not be reported. However, a long-term follow-up is difficult due to the typical senile age of the patients and its questionable clinical relevance in view of their remaining life expectancy. Third, the cases that required greater trochanteric fixation might have different outcomes in comparison with those with an intact greater trochanter.

Conclusion

With the increase in the number of geriatric populations worldwide, the choice of implant with better and long-term results is taking a center stage. Our study did not find any significant difference between the two groups in terms of functional outcome and complication rates. Long-term studies may be required to identify any long-term advantage of calcar replacing versus long stem hemiarthroplasty. Hence, surgeons have a choice to opt for calcar replacement or long hemiarthroplasty in the management of unstable intertrochanteric fractures in the elderly population.

Conflito de Interesses

Os autores declaram não haver conflito de interesses.

Financial and Material Support

Financial and material support was provided by the administration of the AIMC Bassi Hospital, Ludhiana, Punjab. pIncode-151001

Work developed at the Mediways Hospital, Ludhiana, Punjab, India.

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Publikationsverlauf

Eingereicht: 07. Januar 2021

Angenommen: 08. März 2021

Artikel online veröffentlicht:
11. September 2021