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Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 335 - 335
1 Sep 2012
Adelved A Totterman A Glott T Madsen JE Roise O
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Introduction

Displaced fractures in the sacrum are associated with other intra-pelvic organ injuries. There are some reports on short term outcome, however there is little knowledge about the long-term morbidity after these severe injuries.

Aims of study

Describe neurologic deficits in the lower extremities and impairments involving the uro-genital, bowel and sexual functions a minimum of 8 years after injury.

Compare the long-term results with our previously published results after one-year follow-up (1).


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_17 | Pages 1 - 1
11 Oct 2024
Gardner WT Davies P Campbell D Reidy M
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Lateral-entry wiring (LEW) for displaced supracondylar humeral fractures (SHFs) has been popularised internationally. BOAST guidance suggests either LEW or crossed wires; the latter has reported lower risk of loss of fracture reduction –we explore technical reasons why. We reviewed 8 years of displaced SHFs in two regional centres. Injuries were grouped using the Gartland Classification, with posterolateral or posteromedial displacement assessment for Gartland 3 injuries. We identified any loss of fracture reduction, and reviewed intra-operative imaging to identify learning points that may contribute to early rotational displacement (ERD). 345 SHFs were included, between 2012 and 2020. Gartland 2 (n=117) injuries had a 3.42% risk. ERD. Gartland 3 crossed wirings (n=114) had a 6.14% risk of ERD, with those moving all being posterolaterally displaced. Gartland 3, posterolaterally displaced LEW (n=56) had a 35.7% risk of ERD. Gartland 3, posteromedially displaced LEW (n=58) had a 22.4% risk of ERD. All injuries with ERD except 3 had identifiable learning points, the commonest being non-divergence of wires, or wires not passing through both fracture fragments. LEW requires divergent spread and bicolumnar fixation. Achieving a solid construct through this method appears more challenging than crossed wiring, with rates of ERD 3–5× higher. Low-volume surgeons should adhere to BOAST guidelines and choose a wiring construct that works best in their hands. They can also be reassured that should a loss of position occur, the risk of requirement for revision surgery is extremely low in our study (0.3%), and it is unlikely to affect long term outcomes


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_18 | Pages 17 - 17
1 Dec 2023
Sharma N George A Hampton M Barnett A
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Introduction. Trochleoplasty is an effective surgical procedure for patients with severe trochlear dysplasia and recurrent patella instability. Previous work has suggested patients demonstrate early improvements in knee function and quality of life. However, concerns regarding longer term outcomes due to the development of stiffness and patellofemoral osteoarthritis remain a concern for these patients. Our aim was to assess mid-term patient-reported outcome and quality of life measures for trochleoplasty performed at a single centre for severe trochlear dysplasia. Methods. Retrospective review of 28 knees (23 patients) having undergone trochleoplasty for severe trochlear dysplasia were reviewed. Due to the non-parametric nature of the data, median and interquartile range (IQR) were determined for pre-operative and mid-term follow-up scores. Statistically significant differences between groups were assessed using paired Wilcoxon-signed rank test with statistical significance set at p<0.05. Data were analysed using a statistical software package (IBM® SPSS® Statistics 26.0). Results. Median time from surgery to follow-up for all patients in the series was 5.3 years (IQR 3.9 – 7.0 years). Median pre-operative Kujala score improved from 57.0 (IQR 45 – 66) to 96.3 (IQR 83 -100). Median pre-operative IKDC score improved from 42.6 (IQR 35.9 – 51.3) to 92.6 (IQR 71.6 – 98.7). Median EQ-5D score also improved from 0.691 (IQR 0.414 – 0.727) to 1.000 (IQR 0.8178 – 1.000). Improvement in Kujala scores, IKDC scores and EQ-5D were all statistically significant with p<0.001 in all domains. Discussion. Our data suggests patients experience significant improvements in knee function and quality of life following trochleoplasty surgery for severe dysplasia. We demonstrate an absolute improvement in scores at a mean of 5.3 years follow-up of 39.3 points for Kujala, 50 for IKDC and 0.309 for EQ-5D. Minimal clinically important differences (MCID) have been reported to be in the region of 10 for the Kujala score, 8.8–15.6 for IKDC and 0.085 for EQ-5D. Our data shows improvements which far exceed the published MCID, suggesting trochleoplasty confers a large treatment effect and patients benefiting from sustained improvements in knee function and overall quality of life at mid-term follow-up. Conclusion. Following trochleoplasty for severe trochlear dysplasia, patient reported outcomes demonstrate continued improvements in knee function and quality of life at mid-term (5-year) follow-up. There is a large absolute treatment effect which likely impacts on both physical and psychological wellbeing for these patients. Continued surveillance of patient reported outcomes in this clinically complex cohort is indicated


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 958 - 963
1 Jul 2017
Mamarelis G Key S Snook J Aldam C

Aims. Hip hemiarthroplasty is a standard treatment for intracapsular proximal femoral fractures in the frail elderly. In this study we have explored the implications of early return to theatre, within 30 days, on patient outcome following hip hemiarthroplasty. Patients and Methods. We retrospectively reviewed the hospital records of all hip hemiarthroplasties performed in our unit between January 2010 and January 2015. Demographic details, medical backround, details of the primary procedure, complications, subsequent procedures requiring return to theatre, re-admissions, discharge destination and death were collected. Results. A total of 705 procedures were included; 428 Austin Moore and 277 Exeter Trauma Stems were used. A total of 34 fractures (in 33 patients) required early return to theatre within 30 days. Age, gender, laterality, time from admission to primary procedure, American Society of Anesthesiologists grade, and implant type were similar for those requiring early return to theatre and those who did not. Early return to theatre was associated with a significantly higher length of stay (mean 33.6 days (7 to 107) versus 18.6 days (0 to 152), p < 0.001), re-admission rate (38.2% versus 8.6%, p < 0.001), and subsequent revision rate (17.6% versus 1.3%, p < 0.001). We found no difference in level of care required on discharge or mortality. Conclusion. Proximal femoral fractures are common in the elderly population, with far-reaching medical and economic implications. Factors such as infection or dislocation may require early return to theatre, and this is associated with outcomes which may be both medically and economically detrimental. This illustrates the importance of avoiding early complications to improve longer term outcome. Return to theatre within 30 days is associated with longer length of stay, higher re-admission rate, and higher subsequent revision rate. It may be a useful short-term quality indicator for longer term outcome measures following hip hemiarthroplasty for intracapsular fractures of the proximal femur. Cite this article: Bone Joint J 2017;99-B:958–63


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_13 | Pages 17 - 17
1 Jun 2017
Noblet T Jackson P Foster P Taylor D Harwood P Wiper J
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Background. With an ageing population, the incidence of traumatic injuries in those aged over 65 years is increasing. As a result, strategies for dealing with these patients must be developed. At present the standard management of open tibial fractures is described by the BOAST4 guidelines. We describe our experience of managing elderly patients presenting with open tibial fractures to our Major Trauma Centre. Methods. Patients were identified via prospectively collected national and departmental databases. Data collated included patient demographics, injury details, orthopaedic and plastic surgery operative details, and long term outcomes. Results. Between April 2013 and January 2016, 97 patients aged over 65 were admitted with open fractures, 38 of these were open tibial fractures. 10 patients required soft tissue reconstruction for Gustillo and Anderson IIIB tibial fractures (age range 67–95). In this group there were 4 midshaft (AO 42), 1 proximal (AO 41) and 5 distal (AO 43) fractures. Five patients were treated with internal fixation and 5 with circular frames. The median length of hospital stay was 33 days (range 16–113 days), 50% longer than comparable patients under 65. Four patients received pedicled local flaps and six underwent free tissue transfer. Of the 6 patients treated with free tissue transfer, one required pre-operative femoral angioplasty. There were no flap losses. Two patients had fasciocutaneous flaps, one an EDB flap and one gastrocnemius flap. All patients went on to unite and return to their pre-morbid weight-bearing status (2 using frames, 3 using sticks, 5 independent). Discussion. Although the literature suggests a significantly higher complication rate in elderly patients with open fractures, we have demonstrated comparable rates of flap survival and bony union to those observed in younger patients. Challenges are presented in terms of patient physiology and these must be carefully managed pre- and post-operatively. These challenges are reflected in the significantly longer length of stay in comparably injured patients under the age of 65


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_18 | Pages 3 - 3
1 Nov 2016
Clement N Muschik S Gibson J
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There is limited long term evidence to support instrumented fusion as an adjunct to decompression for foraminal stenosis in the presence of single level degenerative disc disease. We report the long term outcome of a prospective randomised controlled trial. Forty-four patients with single-level disc disease were randomly assigned to three groups (spinal decompression (Group 1), decompression and instrumented posterolateral fusion (Group 2), or decompression and instrumented posterolateral fusion plus transforaminal interbody fusion (Group 3). Spinal disability (Dallas, Roland Morris, and Lower Back Outcome Score [LBOS]), and quality of life (EuroQol (EQ) and short form (SF-) 36 questionnaires) were assessed before and at after surgery by independent researchers. At mean of 15 years follow up 33 (75%) patients were available for assessment. All groups observed a significant improvement in the EQ-5D at final follow up. Group 1 demonstrated significantly better functional outcome at final follow up according to the Dallas, Roland Morris, LBOS, and EQ-5D (3L and VAS) scores when compared to the other two groups (p<0.01). The SF-36 score demonstrated that group 1 had significantly better generic health scores compared to groups 2 and 3. Regression analysis was used to adjust for the differences in general health between the groups and demonstrated no significant difference between the groups in the spine specific scores: Dallas (p>0.15), Roland Morris (p>0.37), or the LBOS (p>0.32). Fusion in combination with decompression for the treatment of foraminal stenosis and single level degenerative disc disease offers no long term functional benefit over decompression in isolation


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_17 | Pages 8 - 8
1 Dec 2015
Jamal B Virdy G Aitya S Madeley N Kumar C
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Calcaneal fracture fixation over the past decade has been practised via an extensile lateral incision. This can be complicated by infection and wound breakdown. We have developed a new technique for fixation of the calcaneal fractures – MACO. We utilise a 4 cm sub fibular incision to aid joint visualisation and fracture reduction. Fixation is via percutaneous screws. We analysed our prospectively collected database. 26 fractures were fixed over an 18 month period at Glasgow Royal Infirmary by three consultant surgeons. 22 patients were male and half were smokers. Mean follow up was 5 months (range 1.5 – 18 months). The mean age of our patients is 41 (range 25–68). The mean pre operative Bohler's angle was 16.7 degrees. Gissane's angle was similarly abnormal with a mean of 129 degrees. The average duration of surgery was 73 minutes (range 45–100 minutes). Post operatively, Bohler's angle was improved. The mean was 29 degrees. There was no significant difference with Gissane's angle. The mean was 128 degrees. There were no superficial wound infections. One patient was troubled by wound breakdown with subsequent deep infection. There was no need for metalwork removal in our series of patients. Two patients developed post traumatic osteoarthritis of the sub talar joint. Only one has required sub talar joint fusion. We conclude that the novel technique which we describe is successful in restoring calcaneal anatomy with few complications. Further follow up is needed to determine the long term outcomes of such surgery


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_4 | Pages 13 - 13
1 May 2015
Nicholson J Ahmed I Ning A Wong S Keating J
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This study reports on the natural history of acetabular fracture dislocations. We retrospectively reviewed patients who sustained an acetabular fracture associated with a posterior hip dislocation from a prospective database. Patient characteristics, complications and the requirement for further surgery were recorded. Patient outcomes were measured using the Oxford Hip score and Short Form SF-12 health survey. A total of 99 patients were treated over a 24 year period. The mean age was 41 years. Open reduction and internal fixation was performed in the majority (n=87), 10 were managed conservatively following closed reduction and two underwent primary total hip replacement (THR). At a median follow up of 12.4 years (range 4–24 years) patient outcomes were available for 53 patients. 12 patients had died. 19 patients went onto have a THR as a secondary procedure, of which 11 had confirmed avascular necrosis. Median time to THR was 2 years (range 1–17 years). The mean Oxford hip score was 35 (range 2–48), SF-12 physical component score (PCS) was 40 and a third of the patients used a walking aid. In THR group the mean Oxford score was 32 (range 3–46), SF-12 PCS was 39 and almost all required a walking aid. This is the first study to present the long term outcomes following an acetabular fracture dislocation. Our study suggests there is considerable disability in this group of patients and the requirement for subsequent THR has inferior patient reported outcomes


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_4 | Pages 3 - 3
1 May 2015
Goudie S Gamble D Duckworth A Molyneux S
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An increasing number of distal humeral fractures are presenting as fragility fractures in low demand elderly patients. The optimal management of these injuries remains controversial. The primary aim of this study was to document the short and long term outcomes of these fractures treated with primary nonsurgical intervention. All patients were identified from a prospective trauma database from 1995 to 2010. All conservatively managed, isolated fractures of the distal humerus (OTA Type A,B,C) were included. Prospective long term follow up was collected by telephone interview. Demographic data, fracture classification, management protocol, subsequent surgeries, complications, range of motion, function and patient reported outcomes were recorded. The primary short-term outcome measure was the Broberg and Morrey Elbow Score. The primary long-term outcome measure was the DASH score. Sixty-two patients were included. Mean age 76 (range, 11–96). Low-energy injuries were seen in 97% (59/61) of patients and ≥1 co-morbidities in 50% (27/54). At a mean of 3.7 months (range, 1–14) mean Broberg and Morrey score was 86 (range, 52–100); 70% (28/40) achieving excellent or good short-term outcome. Long-term follow-up was available in 17% (n=11) patients, with 75% (48/64) deceased. At a mean of 7 years (range, 4–17) mean DASH was 23.6 (range, 0.8–45.8), mean Oxford Elbow Score was 42 (range, 32–48). Overall patient satisfaction was 100% (n=11). One patient subsequently underwent open reduction internal fixation for malunion. We have reported satisfactory short-term and longer-term outcomes following the nonsurgical management of isolated distal humerus fractures in older lower demand patients


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 474 - 474
1 Sep 2012
Atrey A Edmondson M East D Miles K Ellens N Butt D Butler-manuel A Warshafsky J Davidson J
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In this review, we present the data of one of the largest non-designer, mid- to long-term follow ups of the AGC. We present a total of 1538 AGC knees during a 15 year period, of which 902 were followed up by postal or telephone questionnaire focused on Oxford Knee Scores, Visual analogues of function and pain and survival analyses performed. Mean length of follow up was 10.4 years. 85.7% of patients had an Oxford knee score of between 0 and 40, with 71.2% scoring between 0–30. 65.6% of patients responded with a Visual Analogue Score (VAS) of 0 or 1 at rest (minimum pain 0) and 53.9% reporting VA scores of 0 or 1 while walking. 87.5% of patients reported Excellent or good functional reports at final follow up and 90.3% reporting excellent or good pain control compared to per-operative levels. Survival analysis confirms excellent survivorship. This large cohort and multi-surgeon trial reproduces the excellent results as demonstrated by the designer centre (Ritter et al.). Mid to long term outcome sows excellent function and analgesia. Complication rates are low and the necessity for revision remains low


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_25 | Pages 1 - 1
1 May 2013
Duckworth A Bugler K Clement N Court-Brown C McQueen M
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The aim of this study was to document both the short and long term outcome of isolated displaced olecranon fractures treated with primary non-operative intervention. We identified from our prospective trauma database all patients who were managed non-operatively for a displaced olecranon fracture over a 13-year period. Inclusion criteria included all isolated fractures of the olecranon with >2 mm displacement of the articular surface. Demographic data, fracture classification, management, complications and subsequent surgeries were recorded. The primary short-term outcome measure was the Broberg and Morrey Elbow score. The primary long-term outcome measure was the DASH score. There were 43 patients in the study cohort with a mean age of 76 yrs (40–98). A low energy fall from standing height accounted for 84% of all injuries, with ≥1 co-morbidities documented in 38 (88%) patients. At a mean of 4 months (range, 1.5–10) following injury the mean Broberg and Morrey score was 83 (48–100), with 72% achieving an excellent or good short-term outcome. Long-term follow-up was available in 53% (n=21) patients, with the remainder deceased. At a mean of six years (2–15) post injury, the mean DASH score was 2.9 (0–33.9), the mean Oxford Elbow Score was 47 (42–48) and overall patient satisfaction was 91% (n=21). We have reported satisfactory short-term and longer-term outcomes following the non-operative management of isolated displaced olecranon fractures in older lower demand patients. Further work is needed to directly compare operative and non-operative management in this patient group


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 90 - 90
1 Sep 2012
Haverkamp D Somford M Klinkenbijl M Vis Van Der H Albers R
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Background. A lot of discussion persists whether obesity negatively influences the outcome of hip arthroplasty. Current literature does not answer this question, since manuscripts showing a worse outcome and those showing a similar outcome can both be found. We performed a meta-analysis with the primary research question whether obesity has a negative influence on short and long term outcome of total hip arthroplasty. Methods. A search of the literature was performed and studies comparing the outcome of hip arthroplasty in different weight groups were included. Methodology of the included studies was scored according to the Cochrane guidelines. Data extraction and pooling of the data was performed. For continuous data a weighted mean difference and for dichotomous variables a weighted Odds ratio was calculated. Heterogeneity was calculated using I2 statistics. Results. A total of 15 studies were available for data-extraction. Dislocation occurred more often in obese with an Odds ratio of 0.54 (95%CI: 0.38–0.75) (10 studies, n = 8634). Aseptic loosening occured more often in obese with an Odds ratio of 0.64 (95% CI 0.43–0.96)(6 studies, n = 5137). Infection occured more often in obese with an Odds Ratio of 0.3 (95%CI: 0.19–0.49) (10 studies, n = 7500). Venous thromboembolism occured more often in obese with an Odds Ratio of 0.56 (95%CI: 0.32–0.98) (7 studies, n = 3716). For septic loosening and intraoperative fractures no difference was found, probably due to low power. Subjective outcome measurements did not allow Pooling due to high heterogeneity (I2 = 68%). Conclusions. We conclude that being obese; ergo having a BMI of more than 30 certainly has a negative influence on total hip replacement


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 269 - 269
1 Sep 2012
Chou D Swamy G Lewis J Badhe N
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Introduction. There has been renewed interest in the unicompartmental knee arthroplasty with reports of good long term outcomes. Advantages over a more extensive knee replacement include: preservation of bone stock, retention of both cruciate ligaments, preservation of other compartments and better knee kinematics. However, a number of authors have commented on the problem of osseous defects requiring technically difficult revision surgery. Furthermore, a number of recent national register studies have shown inferior survivorship when compared to total knee arthroplasty. The purpose of this study was to review the cases of our patients who had a revision total knee arthroplasty for failed unicompartmental knee arthroplasty. To determine the reason for failure, describe the technical difficulties during revision surgery and record the clinical outcomes of the revision arthroplasties. Methods. Between 2003 and 2009 our institute performed thirty three revisions of a unicompartmental knee arthroplasty on thirty two patients. The time to revision surgery ranged from 2 months to 159 months with a median of 19 months. Details of the operations and complications were taken form case notes. Patient assessment included range of motion, need for walking aids and the functional status of the affected knee in the form of the Oxford knee score questionnaire. Results. The reasons for failure were aseptic loosening of tibial component, persistent pain, dislocated meniscus, mal-alignment and osteoarthritis in another compartment. Of the 33 revision knee arthroplasties 18 required additional intra-operative constructs. 11 knees required a long tibial stem while 1 required a long femoral stem. 10 knees required medial wedge augmentation and bone graft was used in 6. Mean 1 year Oxford knee scores for failed unicompartmental knee replacements was 29 compared to 39 for primary total knee replacements performed at the same institute. Of the revision knee replacements 2 required further revision due to infection and loosening. Conclusion. From the evidence of our group of failed unicompartmental knee replacements, revision surgery is technically difficult and often requires intra-operative constructs. Clinical outcome of revision total knee arthroplasty following failed unicompartmental knee arthroplasty is not comparable to primary total knee arthroplasty


The Bone & Joint Journal
Vol. 99-B, Issue 2 | Pages 255 - 260
1 Feb 2017
Macke C Winkelmann M Mommsen P Probst C Zelle B Krettek C Zeckey C

Aims

To analyse the influence of upper extremity trauma on the long-term outcome of polytraumatised patients.

Patients and Methods

A total of 629 multiply injured patients were included in a follow-up study at least ten years after injury (mean age 26.5 years, standard deviation 12.4). The extent of the patients’ injury was classified using the Injury Severity Score. Outcome was measured using the Hannover Score for Polytrauma Outcome (HASPOC), Short Form (SF)-12, rehabilitation duration, and employment status. Outcomes for patients with and without a fracture of the upper extremity were compared and analysed with regard to specific fracture regions and any additional brachial plexus lesion.


The Bone & Joint Journal
Vol. 99-B, Issue 3 | Pages 383 - 392
1 Mar 2017
Handoll HH Keding A Corbacho B Brealey SD Hewitt C Rangan A

Aims

The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up.

Patients and Methods

Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied.


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 1003 - 1008
1 Jul 2016
Fenton P Al-Nammari S Blundell C Davies M

Aims

Although infrequent, a fracture of the cuboid can lead to significant disruption of the integrity of the midfoot and its function. The purpose of this study was to classify the pattern of fractures of the cuboid, relate them to the mechanism of injury and suggest methods of managing them.

Patients and Methods

We performed a retrospective review of patients with radiologically reported cuboid fractures. Fractures were grouped according to commonly occurring patterns of injury. A total of 192 fractures in 188 patients were included. They were classified into five patterns of injury.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 7 | Pages 989 - 993
1 Jul 2010
Johnston AT Barnsdale L Smith R Duncan K Hutchison JD

We investigated the excess mortality risk associated with fractures of the hip. Data related to 29 134 patients who underwent surgery following a fracture of the hip were obtained from the Scottish Hip Fracture Audit database. Fractures due to primary or metastatic malignancy were excluded. An independent database (General Register Office (Scotland)) was used to validate dates of death. The observed deaths per 100 000 of the population were then calculated for each group (gender, age and fracture type) at various time intervals up to eight years. A second database (Interim Life Tables for Scotland, Scottish Government) was then used to create standardised mortality ratios. Analysis showed that mortality in patients aged > 85 years with a fracture of the hip tended to return to the level of the background population between two and five years after the fracture. In those patients aged < 85 years excess mortality associated with hip fracture persisted beyond eight years. Extracapsular hip fractures and male gender also conferred increased risk.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 11 | Pages 1488 - 1494
1 Nov 2007
Gorodetskyi IG Gorodnichenko AI Tursin PS Reshetnyak VK Uskov ON

We undertook a trial on 60 patients with AO 31A2 fractures of the hip who were randomised after stabilisation of the fracture into two equal groups, one of which received post-operative treatment using a non-invasive interactive neurostimulation device and the other with a sham device. All other aspects of their rehabilitation were the same. The treatment was continued for ten days after operation.

Outcome measurements included the use of a visual analogue scale for pain, the brief pain inventory and Ketorolac for post-operative control of pain, and an overall assessment of outcome by the surgeon. There were significantly better results for the patients receiving treatment by active electrical stimulation (repeated measures analysis of variance, p < 0.001). The findings of this pilot trial justify a larger study to determine if these results are more generally applicable.