Historical Implant or Current Best Standard?: Minimum Five year Follow-up Outcomes of Cemented Thompson Hemiarthroplasties A.M. Kassam MRCS, MBBS, BSc, (Hons), S. Griffiths MRCS, MBBS, G. Higgins FRCS, (Trauma and Orth), BSc PII: DOI: Reference:
S0883-5403(14)00290-3 doi: 10.1016/j.arth.2014.04.032 YARTH 53957
To appear in:
Journal of Arthroplasty
Received date: Revised date: Accepted date:
17 December 2013 8 April 2014 27 April 2014
Please cite this article as: Kassam AM, Griffiths S, Higgins G, Historical Implant or Current Best Standard?: Minimum Five year Follow-up Outcomes of Cemented Thompson Hemiarthroplasties, Journal of Arthroplasty (2014), doi: 10.1016/j.arth.2014.04.032
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Historical Implant or Current Best Standard?: Minimum Five year Follow-up Outcomes of Cemented Thompson Hemiarthroplasties
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AM Kassam MRCS MBBS BSc (Hons) S Griffiths MRCS MBBS G Higgins FRCS (Trauma and Orth), BSc Department of Trauma and Orthopaedics, Torbay Hospital, South Devon NHS Foundation Trust, Lawes Bridge, Torquay, TQ2 7AA
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Corresponding author: AM Kassam, Tandem, 10 Palace Gardens, Chudleigh, Devon, TQ13 0PW Email: [email protected] Mobile: 07930502918
ED
Disclaimers: None
PT
Abstract
UK NICE guidelines recommend abandoning the Thompson hemiarthroplasty (TH) in favour
CE
of a `proven prosthesis’ such as the Exeter Trauma Stem. The aim of this study was to assess
AC
the hip fracture treatment with the TH. Between 2002 and 2006, 430 cemented TH’s were performed (minimum 5 year follow-up). Death rates at 1 year and 5 years were 26.6% and 67.4% with low complication (Dislocation 1.4%) and revision rate (1.2%). The TH remains a reliable and proven implant in appropriate patients (over the age of 80, with low activity levels, low ambulatory status and who maybe cognitively impaired), due to low complication and revision rates. Modern implants may provide better function or longevity, but there is little evidence to support abandoning the TH. Keywords Fracture; femur; hip; Thompson; hemiarthroplasty; NICE
ACCEPTED MANUSCRIPT
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Introduction
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The incidence of fractured neck of femur is increasing globally. The United Kingdom National Hip Fracture Database recorded 36,556 events over one year (1). Patients who present with
SC
a fractured neck of femur are typically elderly and frail with extensive co-morbidities and, as a result, there is a high associated mortality and morbidity rate. Approximately £2 billion is
MA NU
spent per year on medical and social management of cases. This figure is expected to
ED
increase with the rise in average population age (2).
Recent National Institute for Clinical Excellence (NICE) guidelines, in the UK, have suggested
PT
discontinuing the use of the Thompson Hemiarthroplasty (TH) prosthesis for treatment of
CE
displaced intracapsular neck of femur fractures. It has been suggested that a proven stem should be utilised in management of these fractures and should have a low failure rate (no
AC
greater than 3% at 3 years and 5% at 5 years). The guidelines also suggest the use of the monopolar Exeter Trauma Stem (ETS) as an alternative implant. Little evidence is documented in the NICE guidelines to support these changes in patient management, which will have a profound change in current National Health Service (NHS) practice along with significant cost implications (2).
There is limited evidence in the published literature documenting the survivorship and revision rates of the TH. Wachti et al published a study demonstrating that the 5 and 10 year
ACCEPTED MANUSCRIPT survivorship of the TH was 94% (3). A retrospective review, by Ruiz-Iban et al, showed that
RI P
T
over a 12 year period only 3 out of 1166 (0.26%) TH’s were revised (4).
There have been few recent publications comparing the TH and ETS with small study
SC
population groups. Parker et al published a randomised controlled trial involving 20 patients and demonstrated that there was no significant difference in complications or revision rates
MA NU
at 1 year between the TH and the ETS (5).
ED
In the South Devon NHS Foundation trust, we routinely utilise the TH for treatment of neck of femur fractures in selective patients. In low demand, elderly patients with altered mental
PT
capacity, we feel that the TH is a suitable implant because of its ease of implantation, low
CE
complication rate and low cost. Our criteria for use of a TH are detailed in table 1. NICE guidelines suggest that we should be routinely implanting a polished, tapered stemmed
AC
prosthesis. This has significant cost implications with no published evidence to demonstrate improved patient benefit.
We reviewed our 5 year history of implantation of the TH. The aim of this study was to identify whether we were utilising the TH in appropriate patients. We hypothesised that the patients who met the criteria for a TH were also the patients that had a reasonably poor life expectancy and would have a low likelihood of revision.
ACCEPTED MANUSCRIPT As an adjunct to this, we also compared the results of the TH to the polished, tapered stem (Exeter Bipolar hemiarthroplasty) that we currently use for appropriate patients in our trust.
T
This prosthesis represents a proven stem, as documented in the NICE guidelines. This would
MA NU
SC
RI P
allow us to identify whether we are choosing the implants utilised in an appropriate manner.
Methods:
We performed a retrospective cohort study of Thompson hemiarthroplasties performed
ED
over a five year period at Torbay hospital between January 2002 and December 2006. As a
PT
comparison, we also assessed Bipolar hemiarthroplasties performed over the same period.
CE
All consecutive patients implanted with TH or BH were enrolled in the study. The population
AC
was identified by a detailed review of the hospital theatre logbooks and cross referencing with the implant logbook to ensure that all cases were correctly identified. Patients not endemic to the local population were excluded to ensure revision and complication data were obtainable.
Torbay Trust has been nationally praised for the successful integration and communication between Primary and Secondary patient Care. (6) These good links meant that we were able to achieve 100% follow-up with no patients being lost to follow-up.
ACCEPTED MANUSCRIPT Patients sustaining a fractured neck of femur were treated routinely according to our Rapid Recovery Pathway. This standardised treatment protocol is applied to all patients treated
T
with hemiarthroplasty, total hip replacements, dynamic hip screws or intra-medullary
RI P
devices. All operations were performed by Consultants, Specialist Registrars or rarely by
SC
experienced Specialty Trainees under supervision.
MA NU
The two cohorts of patients were managed post-operatively in a standardised manner allowing us to minimise bias and confounding factors. This included a radiograph taken in theatre to identify satisfactory implant position, full weight bearing immediately post-op and
PT
ED
physiotherapy review day one post-op.
CE
All the enrolled patient notes were obtained from the clinical records department and demographic details were recorded. Death rates and complication rates were also recorded
AC
from the hospital and coroners records. The patient’s General practitioner was contacted to obtain any further details or missing data.
All the data recorded were with a minimum of 5-years follow-up to allow us to compare with current published NICE guidelines.
Results:
ACCEPTED MANUSCRIPT 430 cemented TH’s were performed at Torbay Hospital in 421 patients over a five year period. The average age at operation was 84.1 years. 194 Bipolar hemiarthoplasties (all
T
cemented Exeter stems) were performed in 191 patients over the same five year period. The
SC
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average age at operation was 76.2 years (Figure 1).
The death rate of patients undergoing TH at 1 year and 5 years were 26.6% and 69.4%
MA NU
respectively. Death rates of patients undergoing BH at 1 year and 5 years, overall, were lower than the TH at 8.4% and 36.1%. Log rank test identified a significant difference in survival between the groups (p80 years old)
Figure 1
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Figure 2
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Figure 3
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Figure 4
ACCEPTED MANUSCRIPT Table 1 – Criteria for use of TH in Torbay Hospital Robotic (n = 30) Manual (n = 32) p-value
Weight (lb)
[Range]
[30 – 74]
M ± SD
66.43 ± 4.80
[Range]
[53 – 72]
M ± SD
60.66 ± 11.78 p = .207 [42 – 81]
T
57.13 ± 9.81
65.64 ± 3.42
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Height (in)
M ± SD
p = .454
[60 – 72]
202.41 ± 41.19 206.95 ± 40.01 p = .661
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Age (yr)
[Range]
[122 – 302]
[142 – 309]
M ± SD
32.13 ± 5.49
33.34 ± 5.70
[Range]
[25 – 50]
[21 – 48]
Gender
%Male (n)
53.3% (16)
34.4% (11)
p = .132
Alcohol use
%Yes (n)
36.7% (11)
28.1% (9)
p = .472
Tobacco use
%Yes (n)
23.3% (7)
18.8% (6)
p = .658
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BMI
CE
PT
Length of first ambulation (ft) ROM day 0 (deg)
M ± SD [Range] M ± SD [Range] M ± SD [Range] M ± SD [Range] M ± SD [Range]
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Length of surgery (hr)
ROM 2 wks (deg)
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Time to inpt PT clearance (hr) Implant coronal alignment Postop tibial slope Femoral axis change Medial tibial overhang
M ± SD [Range] M ± SD [Range] M ± SD [Range] M ± SD [Range]
1.68 ± 0.25 1.48 ± 0.35 [1.33 – 2.35] [1.15 – 3.05] 43.50 ± 47.77 21.16 ± 27.99 [2 – 150] [1 – 140] 69.08 ± 15.93 54.81 ± 20.26 [35 – 92] [0 – 85] 94.81 ± 10.96 100.83 ± 10.91 [70 – 130] [85 – 125] 42.17 ± 14.55 52.47 ± 19.77 [21.50 – 68.93] [23.73 – 117.40] 1.64 ± 1.30 1.10 ± 0.94 [0.03 – 4.24] [0.04 – 3.66] 83.92 ± 1.92 81.66 ± 2.70 [79.59 – 88.05] [76.40 – 86.45] 1.69 ± 1.37 2.59 ± 1.98 [0.06 – 5.04] [0.04 – 8.45] 0.014 ± 0.035 0.132 ± 0.144 [0.00 – 0.14] [0.00 – 0.44]
p = .398
p = .010 p = .027 p = .045 p = .043 p = .024
p = .037 p = .001 p = .051 p < .001
ACCEPTED MANUSCRIPT Table 2 – Complications for Thompsons and Bipolar hemiarthroplasties. All bipolar hemiarthroplasties (194 patients)
Complications 6 (1.4%)
Infections
5 (1.2%)
Periprosthetic fracture
0
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Removal of metalwork
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Revision (excluding for infection)
PT
To THR/Bipolar
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Internal fixation of fracture
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Dislocation
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All Thompson hemiarthroplasties (TH 430 patients)
2 (1.0%) 3 (1.5%) 1 (0.5%)
5 (1.2%)
0
0
6 (3.1%)
0
1 (0.5%)
S0883-5403(14)00290-3 doi: 10.1016/j.arth.2014.04.032 YARTH 53957
To appear in:
Journal of Arthroplasty
Received date: Revised date: Accepted date:
17 December 2013 8 April 2014 27 April 2014
Please cite this article as: Kassam AM, Griffiths S, Higgins G, Historical Implant or Current Best Standard?: Minimum Five year Follow-up Outcomes of Cemented Thompson Hemiarthroplasties, Journal of Arthroplasty (2014), doi: 10.1016/j.arth.2014.04.032
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Historical Implant or Current Best Standard?: Minimum Five year Follow-up Outcomes of Cemented Thompson Hemiarthroplasties
SC
RI P
T
AM Kassam MRCS MBBS BSc (Hons) S Griffiths MRCS MBBS G Higgins FRCS (Trauma and Orth), BSc Department of Trauma and Orthopaedics, Torbay Hospital, South Devon NHS Foundation Trust, Lawes Bridge, Torquay, TQ2 7AA
MA NU
Corresponding author: AM Kassam, Tandem, 10 Palace Gardens, Chudleigh, Devon, TQ13 0PW Email: [email protected] Mobile: 07930502918
ED
Disclaimers: None
PT
Abstract
UK NICE guidelines recommend abandoning the Thompson hemiarthroplasty (TH) in favour
CE
of a `proven prosthesis’ such as the Exeter Trauma Stem. The aim of this study was to assess
AC
the hip fracture treatment with the TH. Between 2002 and 2006, 430 cemented TH’s were performed (minimum 5 year follow-up). Death rates at 1 year and 5 years were 26.6% and 67.4% with low complication (Dislocation 1.4%) and revision rate (1.2%). The TH remains a reliable and proven implant in appropriate patients (over the age of 80, with low activity levels, low ambulatory status and who maybe cognitively impaired), due to low complication and revision rates. Modern implants may provide better function or longevity, but there is little evidence to support abandoning the TH. Keywords Fracture; femur; hip; Thompson; hemiarthroplasty; NICE
ACCEPTED MANUSCRIPT
T
Introduction
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The incidence of fractured neck of femur is increasing globally. The United Kingdom National Hip Fracture Database recorded 36,556 events over one year (1). Patients who present with
SC
a fractured neck of femur are typically elderly and frail with extensive co-morbidities and, as a result, there is a high associated mortality and morbidity rate. Approximately £2 billion is
MA NU
spent per year on medical and social management of cases. This figure is expected to
ED
increase with the rise in average population age (2).
Recent National Institute for Clinical Excellence (NICE) guidelines, in the UK, have suggested
PT
discontinuing the use of the Thompson Hemiarthroplasty (TH) prosthesis for treatment of
CE
displaced intracapsular neck of femur fractures. It has been suggested that a proven stem should be utilised in management of these fractures and should have a low failure rate (no
AC
greater than 3% at 3 years and 5% at 5 years). The guidelines also suggest the use of the monopolar Exeter Trauma Stem (ETS) as an alternative implant. Little evidence is documented in the NICE guidelines to support these changes in patient management, which will have a profound change in current National Health Service (NHS) practice along with significant cost implications (2).
There is limited evidence in the published literature documenting the survivorship and revision rates of the TH. Wachti et al published a study demonstrating that the 5 and 10 year
ACCEPTED MANUSCRIPT survivorship of the TH was 94% (3). A retrospective review, by Ruiz-Iban et al, showed that
RI P
T
over a 12 year period only 3 out of 1166 (0.26%) TH’s were revised (4).
There have been few recent publications comparing the TH and ETS with small study
SC
population groups. Parker et al published a randomised controlled trial involving 20 patients and demonstrated that there was no significant difference in complications or revision rates
MA NU
at 1 year between the TH and the ETS (5).
ED
In the South Devon NHS Foundation trust, we routinely utilise the TH for treatment of neck of femur fractures in selective patients. In low demand, elderly patients with altered mental
PT
capacity, we feel that the TH is a suitable implant because of its ease of implantation, low
CE
complication rate and low cost. Our criteria for use of a TH are detailed in table 1. NICE guidelines suggest that we should be routinely implanting a polished, tapered stemmed
AC
prosthesis. This has significant cost implications with no published evidence to demonstrate improved patient benefit.
We reviewed our 5 year history of implantation of the TH. The aim of this study was to identify whether we were utilising the TH in appropriate patients. We hypothesised that the patients who met the criteria for a TH were also the patients that had a reasonably poor life expectancy and would have a low likelihood of revision.
ACCEPTED MANUSCRIPT As an adjunct to this, we also compared the results of the TH to the polished, tapered stem (Exeter Bipolar hemiarthroplasty) that we currently use for appropriate patients in our trust.
T
This prosthesis represents a proven stem, as documented in the NICE guidelines. This would
MA NU
SC
RI P
allow us to identify whether we are choosing the implants utilised in an appropriate manner.
Methods:
We performed a retrospective cohort study of Thompson hemiarthroplasties performed
ED
over a five year period at Torbay hospital between January 2002 and December 2006. As a
PT
comparison, we also assessed Bipolar hemiarthroplasties performed over the same period.
CE
All consecutive patients implanted with TH or BH were enrolled in the study. The population
AC
was identified by a detailed review of the hospital theatre logbooks and cross referencing with the implant logbook to ensure that all cases were correctly identified. Patients not endemic to the local population were excluded to ensure revision and complication data were obtainable.
Torbay Trust has been nationally praised for the successful integration and communication between Primary and Secondary patient Care. (6) These good links meant that we were able to achieve 100% follow-up with no patients being lost to follow-up.
ACCEPTED MANUSCRIPT Patients sustaining a fractured neck of femur were treated routinely according to our Rapid Recovery Pathway. This standardised treatment protocol is applied to all patients treated
T
with hemiarthroplasty, total hip replacements, dynamic hip screws or intra-medullary
RI P
devices. All operations were performed by Consultants, Specialist Registrars or rarely by
SC
experienced Specialty Trainees under supervision.
MA NU
The two cohorts of patients were managed post-operatively in a standardised manner allowing us to minimise bias and confounding factors. This included a radiograph taken in theatre to identify satisfactory implant position, full weight bearing immediately post-op and
PT
ED
physiotherapy review day one post-op.
CE
All the enrolled patient notes were obtained from the clinical records department and demographic details were recorded. Death rates and complication rates were also recorded
AC
from the hospital and coroners records. The patient’s General practitioner was contacted to obtain any further details or missing data.
All the data recorded were with a minimum of 5-years follow-up to allow us to compare with current published NICE guidelines.
Results:
ACCEPTED MANUSCRIPT 430 cemented TH’s were performed at Torbay Hospital in 421 patients over a five year period. The average age at operation was 84.1 years. 194 Bipolar hemiarthoplasties (all
T
cemented Exeter stems) were performed in 191 patients over the same five year period. The
SC
RI P
average age at operation was 76.2 years (Figure 1).
The death rate of patients undergoing TH at 1 year and 5 years were 26.6% and 69.4%
MA NU
respectively. Death rates of patients undergoing BH at 1 year and 5 years, overall, were lower than the TH at 8.4% and 36.1%. Log rank test identified a significant difference in survival between the groups (p80 years old)
Figure 1
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Figure 2
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Figure 3
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Figure 4
ACCEPTED MANUSCRIPT Table 1 – Criteria for use of TH in Torbay Hospital Robotic (n = 30) Manual (n = 32) p-value
Weight (lb)
[Range]
[30 – 74]
M ± SD
66.43 ± 4.80
[Range]
[53 – 72]
M ± SD
60.66 ± 11.78 p = .207 [42 – 81]
T
57.13 ± 9.81
65.64 ± 3.42
RI P
Height (in)
M ± SD
p = .454
[60 – 72]
202.41 ± 41.19 206.95 ± 40.01 p = .661
SC
Age (yr)
[Range]
[122 – 302]
[142 – 309]
M ± SD
32.13 ± 5.49
33.34 ± 5.70
[Range]
[25 – 50]
[21 – 48]
Gender
%Male (n)
53.3% (16)
34.4% (11)
p = .132
Alcohol use
%Yes (n)
36.7% (11)
28.1% (9)
p = .472
Tobacco use
%Yes (n)
23.3% (7)
18.8% (6)
p = .658
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BMI
CE
PT
Length of first ambulation (ft) ROM day 0 (deg)
M ± SD [Range] M ± SD [Range] M ± SD [Range] M ± SD [Range] M ± SD [Range]
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Length of surgery (hr)
ROM 2 wks (deg)
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Time to inpt PT clearance (hr) Implant coronal alignment Postop tibial slope Femoral axis change Medial tibial overhang
M ± SD [Range] M ± SD [Range] M ± SD [Range] M ± SD [Range]
1.68 ± 0.25 1.48 ± 0.35 [1.33 – 2.35] [1.15 – 3.05] 43.50 ± 47.77 21.16 ± 27.99 [2 – 150] [1 – 140] 69.08 ± 15.93 54.81 ± 20.26 [35 – 92] [0 – 85] 94.81 ± 10.96 100.83 ± 10.91 [70 – 130] [85 – 125] 42.17 ± 14.55 52.47 ± 19.77 [21.50 – 68.93] [23.73 – 117.40] 1.64 ± 1.30 1.10 ± 0.94 [0.03 – 4.24] [0.04 – 3.66] 83.92 ± 1.92 81.66 ± 2.70 [79.59 – 88.05] [76.40 – 86.45] 1.69 ± 1.37 2.59 ± 1.98 [0.06 – 5.04] [0.04 – 8.45] 0.014 ± 0.035 0.132 ± 0.144 [0.00 – 0.14] [0.00 – 0.44]
p = .398
p = .010 p = .027 p = .045 p = .043 p = .024
p = .037 p = .001 p = .051 p < .001
ACCEPTED MANUSCRIPT Table 2 – Complications for Thompsons and Bipolar hemiarthroplasties. All bipolar hemiarthroplasties (194 patients)
Complications 6 (1.4%)
Infections
5 (1.2%)
Periprosthetic fracture
0
ED
Removal of metalwork
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Revision (excluding for infection)
PT
To THR/Bipolar
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Internal fixation of fracture
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Dislocation
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T
All Thompson hemiarthroplasties (TH 430 patients)
2 (1.0%) 3 (1.5%) 1 (0.5%)
5 (1.2%)
0
0
6 (3.1%)
0
1 (0.5%)
