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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 13 - 13
1 May 2016
Manalo J Patel A Goyal N Fitz D Talati R Stulberg S
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Introduction

Current techniques in total knee arthroplasty aim to restore the coronal mechanical axis to neutral. Preoperative planning has historically been based on long-leg standing films (LLSF) which allow surgeons to plan bony resection and soft tissue releases. However, LSSF can be prone to error if malrotated. Recently, patient-specific guides (PSG) utilizing supine magnetic resonance imaging (sMRI) have become an accepted technique for preoperative planning. In this study we sought to compare the degree of coronal deformity using LLSF and sMRI.

Methods

Two hundred thirty knees underwent planning for total knee arthroplasty with sMRI and LLSF. Coronal plane deformity was determined based on the femoral-tibial angle (FTA) as defined by the angle formed between a line from the center of the femoral head to the intercondylar notch and a line from the middle of the tibial spines to the middle of the ankle joint. Mechanical axis values from the sMRI were compared with values obtained from LLSF


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 53 - 53
1 Jan 2016
Talati R Alvi H Sweeney P Patel A Stulberg SD
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Introduction

Total knee arthroplasty is effective for the management of osteoarthritis of the knee. Conventional techniques utilizing manual instrumentation (MI) make use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. While MI techniques can achieve excellent results in the majority of patients, those with ipsilateral hardware, post-traumatic deformity or abnormal anatomy may be technically more challenging, resulting in poorer outcomes. Computer-assisted navigation (CAN) is an alternative that utilizes fixed trackers and anatomic registration points, foregoing the need for intramedullary guides. This technique has been shown to yield excellent results including superior alignment outcomes compared to MI with fewer outliers. However, studies report a high learning curve, increased expenses and increased operative times. As a result, few surgeons are trained and comfortable utilizing CAN. Patient-specific instrumentation is an alternative innovation for total knee arthroplasty. Custom guide blocks are fabricated based on a patient's unique anatomy, allowing for the benefits of CAN but without the increased operative times or the high learning curve. In this study we sought to evaluate the accuracy of PSI techniques in patients with previous ipsilateral hardware of the femur.

Methods

After reviewing our database of 300 PSI total knee arthroplasty patients, 16 were identified (10 male, 6 female) using the Zimmer NexGen Patient Specific Instrumentation System. Fourteen patients included in the study had a preexisting total hip arthroplasty on the ipsilateral side [Figure 1], 1 had a sliding hip screw, and 1 patient had a cephalomedullary nail. Postoperative mechanical axis alignment measurements were performed using plain long-standing radiographs [Figure 2]. The American Knee Society Score was used to evaluate clinical outcomes postoperatively.


The Bone & Joint Journal
Vol. 97-B, Issue 12 | Pages 1683 - 1692
1 Dec 2015
Patel A James SL Davies AM Botchu R

The widespread use of MRI has revolutionised the diagnostic process for spinal disorders. A typical protocol for spinal MRI includes T1 and T2 weighted sequences in both axial and sagittal planes. While such an imaging protocol is appropriate to detect pathological processes in the vast majority of patients, a number of additional sequences and advanced techniques are emerging. The purpose of the article is to discuss both established techniques that are gaining popularity in the field of spinal imaging and to introduce some of the more novel ‘advanced’ MRI sequences with examples to highlight their potential uses.

Cite this article: Bone Joint J 2015;97-B:1683–92.


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1170 - 1174
1 Sep 2015
Patel A Pavlou G Ahmad RA Toms A

In England and Wales more than 175 000 hip and knee arthroplasties were performed in 2012. There continues to be a steady increase in the demand for joint arthroplasty because of population demographics and improving survivorship. Inevitably though the absolute number of periprosthetic infections will probably increase with severe consequences on healthcare provision. The Department of Health and the Health Protection Agency in United Kingdom established a Surgical Site Infection surveillance service (SSISS) in 1997 to undertake surveillance of surgical site infections. In 2004 mandatory reporting was introduced for one quarter of each year. There has been a wide variation in reporting rates with variable engagement with the process. The aim of this article is to improve surgeon awareness of the process and emphasise the importance of engaging with SSISS to improve the quality and type of data submitted. In Exeter we have been improving our practice by engaging with SSISS. Orthopaedic surgeons need to take ownership of the data that are submitted to ensure these are accurate and comprehensive.

Cite this article: Bone Joint J 2015;97-B:1170–4.


The Bone & Joint Journal
Vol. 97-B, Issue 8 | Pages 1076 - 1081
1 Aug 2015
Patel A Pavlou G Mújica-Mota RE Toms AD

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are recognised and proven interventions for patients with advanced arthritis. Studies to date have demonstrated a steady increase in the requirement for primary and revision procedures. Projected estimates made for the United States show that by 2030 the demand for primary TKA will grow by 673% and for revision TKA by 601% from the level in 2005. For THA the projected estimates are 174% and 137% for primary and revision surgery, respectively. The purpose of this study was to see if those predictions were similar for England and Wales using data from the National Joint Registry and the Office of National Statistics.

Analysis of data for England and Wales suggest that by 2030, the volume of primary and revision TKAs will have increased by 117% and 332%, respectively between 2012 and 2030. The data for the United States translates to a 306% cumulative rate of increase between 2012 and 2030 for revision surgery, which is similar to our predictions for England and Wales.

The predictions from the United States for primary TKA were similar to our upper limit projections. For THA, we predicted an increase of 134% and 31% for primary and revision hip surgery, respectively.

Our model has limitations, however, it highlights the economic burden of arthroplasty in the future in England and Wales as a real and unaddressed problem. This will have significant implications for the provision of health care and the management of orthopaedic services in the future.

Cite this article: Bone Joint J 2015;97-B:1076–1081.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_15 | Pages 33 - 33
1 Oct 2014
Molloy S Butler J Patel A Bentom A Jassim S Sewell M Aftab S
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To assess the clinical and radiologic outcome of MM patients with thoracic spine involvement and concomitant pathologic sternal fractures with a resultant severe sagittal plane deformity.

A prospective cohort study (n=391) was performed over a 7-year period at a national tertiary referral centre for the management of multiple myeloma with spinal involvement. Clinical, serological and pathologic variables, radiologic findings, treatment strategies and outcome measures were prospectively collected. Pre-treatment and post-treatment clinical outcome measures utilised included EQ-5D, VAS, ODI and RMD scoring systems.

13 MM patients presented with a severe symptomatic progressive sagittal plane deformity with a history of pathologic thoracic compression fractures and concomitant pathologic sternal fracture. All patients with concomitant sternal fractures displayed the radiographic features and spinopelvic parameters of positive sagittal malalignment and attempted clinical compensation. All patients had poor health related quality of life measures when assessed.

Pathologic sternal fracture in a MM patient with thoracic compression fractures is a risk factor for the development of a severe thoracic kyphotic deformity and sagittal malalignment. This has been demonstrated to be associated with a very poor health related quality of life.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_15 | Pages 30 - 30
1 Oct 2014
Molloy S Aftab S Patel A Butler J Balaji V Wilson L Lee R
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To assess screw malposition rates and complications associated with pedicle screw insertion using 3D navigation technology.

A retrospective study was undertaken for all cases where O-arm® and StealthStation® systems were used over a 2-year period. The primary outcome measure was return to theatre rates for pedicle screw malposition.

A total of 938 screws were inserted (934 thoracolumbar and 4 cervical), and 103 patients underwent spinal fixation using O-arm® and StealthStation® navigation. 64 were revision cases and 39 primary cases. Average number of levels was 4.6. There were a total of 10 complications: 3 infections, 1 DVT, 1 PE, 1 fast atrial fibrillation (AF), 1 screw malposition, 1 non-union, 1 undisplaced vertebral body fracture and 1 nerve root compression following osteotomy. The percentage return to theatre for screw malposition using 3D navigation was 1% of patients and 0.1% of pedicle screws. No patients developed permanent neurological compromise.

These systems provide accuracy that is comparable to traditional 2D fluoroscopic techniques. We advocate their use in the safe insertion of pedicle screws in complex revision deformity cases where original anatomical landmarks are absent or obscured. We also believe that radiation exposure is considerably less with navigation especially in these complex and revision cases.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 96 - 96
1 Jul 2014
Geurts J Patel A Helmrich U Hirschmann M Müller-Gerbl M Valderrabano V Hügle T
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Summary Statement

Cross-talk between cells from immune and bone system might play a role in molecular regulation of subchondral bone sclerosis in osteoarthritis. Macrophages, B-lymphocytes and tartrate-resistant acid phosphatase activity are specifically increased in sclerotic subchondral bone of patients with knee osteoarthritis.

Background

Recent investigations have provided substantial evidence that distinct molecular and morphological changes in subchondral bone tissue, most notably sclerosis, play an active and important role in the pathogenesis of OA. The cellular and molecular regulation of this pathological process remains poorly understood. Here, we investigated whether osteoimmunology, the reciprocal signaling between cells from the immune and bone system, is involved in OA subchondral bone sclerosis.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_2 | Pages 21 - 21
1 Jan 2014
Ribee H Bhalla A Patel A Johnson B Leah J Bailey A Chapman C Bing A Hill S Laing P Makwana N Thomason K Marquis C
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Introduction:

Plantar Fasciitis is an extremely common and challenging problem that presents itself to foot and ankle practitioners. Many different treatment modalities are available for this condition, with little proven benefit. ECSWT was approved for use by the FDA for the treatment of chronic proximal plantar fasciitis in 2002 and NICE published guidance in 2009 recommending its use in refractory cases.

Methods:

Patients who diagnosed with ultrasound scan, and for whom other treatments were unsuccessful, underwent treatment on an outpatient basis. They had three 4–5 minute sessions, once a week. A Spectrum machine was used delivering 10 Hz waves in 500 preset pulses at 2 bar pressure, followed by 2000 preset pulses at 2.5 bar pressure. Pre- and 3 month post-treatment pain levels were recorded using a 10 point Visual Analogue Scale.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 539 - 539
1 Dec 2013
Alvi H Luo M Talati R Sweeney P Patel A Yaffe M Stulberg SD
Full Access

Introduction:

Total knee arthroplasty (TKA) is an effective operation for the management of osteoarthritis of the knee. Conventional technique utilizing manual instrumentation (MI) allows for reproducible and accurate execution of the procedure. The most common techniques make use of intramedullary femoral guides and either extrameduallary or intrameduallary tibial guides. While these methods can achieve excellent results in the majority of patients, those with ipsilateral hardware, post-traumatic deformity or abnormal anatomy may preclude the accurate use of these techniques.

Patient-specific instrumentation (PSI) is an alternative innovation for total knee arthroplasty. Utilizing magnetic resonance imaging (MRI) or computed tomography (CT), custom guide blocks are fabricated based on a patient's unique anatomy. This allows for the benefits of computer assisted navigation (CAN) but without the increased operative times or the high learning curve associated with it. Furthermore it allows the use of familiar cutting blocks and guides to check the accuracy of the PSI guide blocks. In this study we sought to evaluate the accuracy of PSI techniques in patients with previous ipsilateral hardware, which would make the use of MI technically challenging and possibly subject to inaccuracy.

Methods:

After reviewing our database of 300 PSI total knee arthroplasty patients, 16 patients were identified (10 male, 6 female) using the Zimmer NexGen Patient Specific Instrumentation System. Fourteen patients included in the study had a preexisting total hip arthroplasty on the ipsilateral side, 1 had a preexisting sliding hip screw, and 1 patient had a preexisting cephalomedullary nail. Postoperative mechanical axis alignment measurements were performed using plain long-standing radiographs. The American Knee Society Score was used to evaluate clinical outcomes postoperatively.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 176 - 176
1 Dec 2013
Stulberg SD Alvi H Talati R Patel A Yaffe M
Full Access

Introduction:

Patient specific instrumentation (PSI) is an innovative technology in total knee arthroplasty. With the use of a preoperative MRI or CT scan, custom guide blocks are individually manufactured for each patient. Contrary to other TKA technologies such as computer-assisted surgery, PSI utilizes measured resection technique rather than a primarily ligament balancing technique. This has the potential to negatively affect the operating surgeon's ability to achieve optimal soft tissue balancing, which is especially critical in patients with severe lower extremity malalignment. Despite early research suggesting that PSI is accurate, has a low learning curve, and can reduce OR time, it remains unclear whether a surgeon using PSI can achieve optimal soft tissue balancing using a measured resection technique. The purpose of this study is to evaluate the efficacy of PSI in patients with severe preoperative limb alignment deformities.

Methods:

Fifty PSI total knee arthroplasties were performed on 46 patients (21 male, 25 female) using the Zimmer NexGen Patient Specific Instrumentation system. Each patient included in the study had a minimum preoperative deformity of at least 10° varus or valgus measured on preoperative long leg standing radiographs, Zimmer preoperative software or both. Forty-three of the included knees had a varus deformity and 7 had a valgus deformity. Preoperative mechanical axis alignment measurements were obtained using the PSI preoperative planning software and were manually calculated using pre-operative long leg standing radiographs. Postoperative mechanical axis alignment measurements were calculated using plain long leg standing radiographs. The Knee Society Scoring System was used to evaluate clinical and functional outcomes at 1 to 6 months postoperatively.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 67 - 67
1 Dec 2013
Goyal N Patel A Yaffe M Luo M Stulberg SD
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Introduction:

Patient specific instrumentation (PSI) generates customized guides from a magnetic resonance imaging based preoperative plan for use in total knee arthroplasty (TKA). PSI software must be able to accommodate differences in implant design. The purpose of the present study was to determine whether any differences in the accuracy of limb alignment, component alignment, component sizing, or bony resection could be identified in patients undergoing PSI TKA with identical PSI software and one of two different implant systems.

Methods:

In this case-control study, two different implant systems from the same manufacturer were evaluated in 37 consecutive PSI TKA (Group 1) and 123 consecutive PSI TKA (Group 2) performed by a single surgeon. A third group (Group 3) consisted of 12 consecutive TKA performed with manual instrumentation and the same implant system as Group 1. Identical software was used to generate a preoperative plan from which planned limb alignment, component alignment, component sizes, and bony resection were determined. Intraoperatively, actual component sizes, bony resection, and recut frequency were determined. Long-standing and lateral radiographs were obtained preoperatively and 4-weeks postoperatively to evaluate limb and component alignment.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 106 - 106
1 Aug 2013
Alvi H Talati R Patel A Yaffe M Stulberg S
Full Access

Introduction

Patient specific instrumentation (PSI) is an innovative technology in total knee arthroplasty (TKA). With the use of a preoperative MRI or CT scan, custom guide blocks are individually manufactured for each patient. Contrary to other TKA technologies such as computer-assisted surgery, PSI utilises measured resection technique rather than a primarily ligament balancing technique. This has the potential to negatively affect the operating surgeon's ability to achieve optimal soft tissue balancing, which is especially critical in patients with severe lower extremity malalignment. Despite early research suggesting that PSI is accurate, has a low learning curve, and can reduce operating room time, it remains unclear whether a surgeon using PSI can achieve optimal soft tissue balancing using a measured resection technique. The purpose of this study is to evaluate the efficacy of PSI in patients with severe preoperative limb alignment deformities.

Methods

Fifty PSI total knee arthroplasties were performed on 46 patients (21 male, 25 female) using the Zimmer NexGen Patient Specific Instrumentation system. Each patient included in the study had a minimum preoperative deformity of at least 10° varus or valgus measured on preoperative long leg standing radiographs, Zimmer preoperative software or both. Forty-three of the included knees had a varus deformity and 7 had a valgus deformity. Preoperative mechanical axis alignment measurements were obtained using the PSI preoperative planning software and were manually calculated using preoperative long leg standing radiographs. Postoperative mechanical axis alignment measurements were calculated using plain long leg standing radiographs. The Knee Society Scoring System was used to evaluate clinical and functional outcomes at 1 to 6 months postoperatively.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 301 - 301
1 Mar 2013
Patel A Patel R Thomas D Stulberg SD Bauer T
Full Access

Introduction

Modular femoral necks have shown promising clinical results in total hip arthroplasty (THA) to optimize offset, rotation, and leg length. Given the wide variety of proximal femoral morphology, fine-tuning these kinematic parameters can help decrease femoroacetabular impingement, decrease wear rates and help prevent dislocations. Yet, additional implant junctions introduce additional mechanisms of failure. We present two patients who developed an abnormal soft tissue reaction consistent with a metal hypersensitivity reaction at a modular femoral neck/stem junction requiring revision arthroplasty.

Methods

Two patients underwent THA for primary osteoarthritis with the same series of components: 50 mm shell, a 36 mm highly-crosslinked polyethylene liner, uncemented titanium alloy modular stem with a 130 degree Cobalt Chromium (CoCr) modular femoral neck, and 36 mm CoCr head with a +5-mm offset. Patient 1 was a 63 year-old female who had an uneventful post-operative course but presented seven months later with progressive pain in the left hip. Patient 2 was an 80 year-old female who did well post-operatively, but presented with limp and persistent pain at 10 months post-op.

An initial evaluation of a painful THA to rule out aseptic loosening, infection, mal-positioning, loosening and osteolysis included radiographs, lab work (CBC, ESR, CRP, Cobalt & Chromium levels) and Metal Artifact Reduction Sequence (MARS) MRI.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 362 - 362
1 Mar 2013
Yaffe M Patel A Luo M Chan P Cayo M Stulberg SD
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Introduction

Patient specific instruments (PSI) and computer-assisted surgery (CAS) are innovative technologies that offer the potential to improve the accuracy and reproducibility with which a total knee arthroplasty (TKA) is performed. It has not been established whether clinical, functional, or radiographic outcomes between PSI, CAS, and manual TKA differ in the hands of an experienced TKA surgeon. The purpose of this study was to evaluate clinical, functional and radiographic outcomes between TKA performed with PSI, CAS, and manual instruments at short-term follow-up. Our hypothesis was that at early follow-up, we would be unable to elucidate any significant differences between the groups using the most commonly utilized outcomes measures.

Methods

40 PSI, 38 CAS, and 40 manual TKA were performed by a single surgeon. The groups were similar in regards to age, sex, and preoperative diagnosis. The Knee Society Scoring System was used to evaluate patient clinical and functional outcome scores preoperatively and at 1 and 6 months postoperatively. Long-standing AP radiographs were obtained pre and postoperative to evaluate mechanical axis alignment.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 300 - 300
1 Mar 2013
Patel A Yaffe M Talati R Meisles J Ghate R Stulberg SD
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Introduction

Proper femoral component rotation is a crucial factor in successful total knee arthroplasty (TKA). Femoral component rotation using anatomic landmarks has traditionally been established by referencing the transepicondylar axis (TEA), Whiteside's Line (WSL), or the posterior condylar axis (PCA). TEA is thought to best approximate the flexion-axis of the knee, however WSL or PCA are commonly used as surrogates of the TEA in the operating room due to their accessibility. The relationship of these anatomic landmarks has been previously investigated in anatomic and computed tomography based studies. The relatively few knees evaluated have limited the power of these studies. Patient Specific Instrumentation (PSI) utilizing magnetic resonance imaging (MRI) is an emerging technology in total knee replacement. The purpose of this study was to use magnetic resonance imaging based planning software to assess the relationship of WSL and PCA to the TEA and to determine if the relationships were influenced by the magnitude of the pre-operative coronal deformity.

Methods

Five hundred sixty total knee replacements were performed in 510 patients utilizing PSI. The Materialize preoperative planning software was utilized to determine the rotational relationships of TEA, WSL, and PCA (Fig 1). The coronal plane deformity of each patient was also evaluated utilizing the MRI-based imaging and planning software.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 108 - 108
1 Jan 2013
Patel A Anand A Alam M Anand B
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Background

Both-bone diaphyseal forearm fractures constitute up to 5.4% of all fractures in children under 16 years of age in the United Kingdom. Most can be managed with closed reduction and cast immobilisation. Surgical fixation options include flexible intramedullary nailing and plating. However, the optimal method is controversial.

Objectives

The main purpose of this study was to systematically search for and critically appraise articles comparing functional outcomes, radiographic outcomes and complications of nailing and plating for both-bone diaphyseal forearm fractures in children.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 226 - 226
1 Jan 2013
Patel A Anand A Anand B Alam M
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Introduction

Indications for the use of external fixation include damage control orthopaedics, definitive fracture treatment, deformity correction and leg lengthening. Despite many advances in the development of external fixation techniques, pin-tract infection and loosening are still significant complications. They are the most commonly occurring complications during limb lengthening using external fixation, with some studies reporting an incidence of up to 80%.

Objectives

The main aim of this systematic review was to investigate HA-coated versus uncoated external fixator pins used in patients undergoing leg lengthening and determine benefits in terms of pin loosening, infection and loss of reduction/malunion.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 96 - 96
1 Sep 2012
van Dijck S Young S Patel A Zhu M Bevan W Tomlinson M
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Acute achilles tendon ruptures are increasing in incidence and occur in 18 per 100 000 people per year, however there remains a lack of consensus on the best treatment of acute ruptures. Randomised studies comparing operative versus non-operative treatment show operative treatment to have a significantly lower re-rupture rate, but these studies have generally used non-weight bearing casts in the non-operative group.

Recent series utilizing more aggressive non-operative protocols with early weight-bearing have noted a far lower incidence of re-rupture, with rates approaching those of operative management. Weight bearing casts may also have the advantages of convenience and an earlier return to work, and the purpose of this study was to compare outcomes of traditional casts versus Bohler-iron equipped weight-bearing casts in the treatment of acute Achilles tendon ruptures.

83 patients with acute Achilles tendon ruptures were recruited from three Auckland centres over a 2 year period. Patients were randomised within one week of injury to receive either a weight-bearing cast with a Bohler iron or a traditional non weight-bearing cast. A set treatment protocol was used, with a total cast time of eight weeks. Patients underwent detailed muscle dynamometry testing at 6 months, with further follow up at 1 year and at study completion. Primary outcomes assessed were patient satisfaction, time to return to work, and overall re-rupture rates. Secondary outcomes included return to sports, ankle pain and stiffness, footwear restrictions, and patient satisfaction.

There were no significant differences in patient demographics or activity levels prior to treatment. At follow up, 1 patient (2%) in the Bohler iron group and 2 patients (5%) in the non weight bearing group sustained re-ruptures (p=0.62). There was a trend toward an earlier return to work in the weight-bearing group, with 58% versus 43% returning to work within 4 weeks, but the difference was not significant. 63% of patients in the weight bearing group reported freedom from pain at 12 months compared to 51 % in the non weight bearing group. There were no statistically significant differences in Leppilahti scores, patient satisfaction, or return to sports between groups.

Weight-bearing casts in the non-operative treatment of Achilles tendon ruptures appear to offer outcomes that are at least equivalent to outcomes of non-weight bearing casts. The overall rerupture rate in this study is low, supporting the continued use of initial non-operative management in the treatment of acute ruptures.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 519 - 519
1 Sep 2012
Ahmad M Sivaraman A Rai A Patel A
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Background

Distal tibial metaphyseal fractures pose many complexities. This study assessed the outcomes of distal tibial fractures treated with percutaneously inserted medial locking plates.

Methods

Eighteen patients were selected based on the fracture pattern and classified using the AO classification and stabilised with an AO medial tibial locking plate. Time to fracture union, complications and outcomes were assessed with the American Orthopaedic Foot and Ankle Society ankle score at 12 months.