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Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 134 - 134
1 Mar 2010
Kim SW Limson MA Kim SB Arbatin JJF Park MS Shin JH Ju YS
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Background: Cervical myelopathy and radiculopathy has been treated commonly with anterior cervical decompression and fusion with autologous bone graft and anterior cervical plating. Long term results have shown excellent pain relief and 73%–90% fusion rates. However, the development of late adjacent-level disease has been reported following anterior cervical arthrodesis which recently have been correlated to clinical findings. The Bryan disc arthroplasty device was developed to preserve the kinematics of the functional spine unit thus preventing adjacent level disease. There have been few studies comparing the incidence of adjacent level changes in patients undergoing ACDF compared to implantation of a Bryan disc arthroplasty device. Objectives: The object of this study is to compare the clinical results and radiographic outcomes of anterior cervical decompression and fusion versus cervical disc replacement using the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) in terms of overall range of motion (ROM) of the cervical spine; ROM, anterior intervertebral height (AIH), posterior intervertebral height (PIH) and radiographic changes at the implanted and adjacent levels. Methods: The study consisted of 105 patients with symptomatic single or two-level cervical disc disease. Fifty-one received the Bryan Cervical Artificial Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN). A total of 63 Bryan disc were placed in these 51 patients. A single-level procedure was performed in 39 patients and a two-level procedure in the other twelve. The patient group who underwent ACDF totaled 54 patients which consisted of 26 single level cases and 28 double level cases. The Bryan group had a mean follow-up 19 months (12–38). The mean follow-up for the ACDF group was 20 months (12–40 months). All patients were evaluated using static and dynamic cervical spine radiographs as well as MR imaging. All patients underwent anterior cervical discectomy followed by anterior cervical plating or implantation of the Bryan artificial disc prosthesis, done by one surgeon. Clinical evaluation included the visual analogue scale (VAS), and neck disability index (NDI). Radiographic evaluation included static and dynamic flexion-extension radiographs in an upright position using the computer software (Infinitt PiviewSTAR 5051) program. Range of motion/disc space angle and inter vertebral height were measured at the operative site and adjacent levels. Functional spinal unit (FSU) and overall sagittal alignment (C2–C7) were also measured pre-operatively, postoperatively and at final follow-up. ROM was calculated for all 3 areas and data collected were compared from pre operative to last follow-up as well as between the two groups. Radiographic assessment for adjacent level changes was also done. Radiologic change was analyzed using chi square test (95% confidence interval). Other data were analyzed using the mixed model. (SAS enterprise guide 4.1 version). Results: There was clinical improvement within each group in terms of VAS and NDI scores from pre-op to final follow-up for both single (VAS: p=0.8371, NDI: p=0.2872) and double (VAS: p=0.2938, NDI: p=0.6753) level surgeries but not significantly between the two groups. Overall, ROM and intervertebral height was relatively well maintained during the follow-up in the Bryan group compared to ACDF. Comparing the pattern of ROM measurements from pre-op to final follow-up between the two arms regardless of the number of levels operated on; significant differences were noted for overall ROM of the cervical spine (p< .0001) and all other levels except at the upper level for single level surgeries (p=0.2872). In terms of inter vertebral height measurements from pre-op to final follow-up, statistically significant (p< 0.0001 and p=0.0172) differences in the pattern between the two groups were noted at all levels except for the AIH of single level surgeries at the upper (p=0.1264) and lower (p=0.7598) levels as well as PIH for double level surgeries at the upper (p=0.8363) level. Radiologic change was 3.5 times more observed for the ACDF group compared to the Bryan group. Conclusion: Clinical status of both groups, regardless of the number of levels, showed improvement. Although clinical outcomes between the two groups were not significantly different at final follow-up, radiographic parameters, namely ROM and intervertebral heights at the operated site, some adjacent levels as well as FSU and overall sagittal alignment of the cervical spine were relatively well maintained in our Bryan group compared to our ACDF group. We surmise that to a certain degree, the maintenance of these parameters could contribute to reduce development of adjacent level change. Noteworthy is that radiographic change was 3.5 times more observed for ACDF surgeries. A longer period of evaluation is needed, to see if all these radiographic changes will translate to symptomatic adjacent level disease


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 463 - 463
1 Sep 2009
Dakhil-Jerew F
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Introduction: ACDF involves cancellation of the diseased spinal motion segment, the neighboring spinal segments take the burden of excessive compensatory spinal movements and strain resulting in early degeneration. Adjacent segment degeneration with new, symptomatic radiculopathy occurs after ACDF in 2–3% of patients per year on cumulative basis. An estimated 15% of patients ultimately require a secondary procedure at an adjacent level. An alternative to fusion is total disc arthroplasty (TDA). The key advantage of this promising technology is restoration and maintenance of normal physiological motion rather than elimination of motion. We describe 4 patients with a serious complication observed following implantation of the Bryan disc prosthesis in our cohort of 48 patients. Material and Results:. Patient #1: 43 M, with neck pain & left brachalgia, with left C6 dermatome signs, with MRI findings of C5/6 disc prolapse with left C6 root impingement, undergoing C5/6 Bryan TDA in April 2004, with treatment recommendation of C3/4 and C6/7 Bryan TDA in January 2006. Patient #2: 47 M, with worsening gait over 2 years with right brachalgia, with findings of progressive cervical myelopathy with right C5 radiculopathy, with MRI findings of severe C5/6 disc degeneration with spinal cord compression, undergoing C5/6 Bryan TDA in January 2003, with MRI FU findings after 16/12 with new left C6/7 disc prolapse and left C6 radiculopathy, with treatment recommendation of C6/7 Bryan TDA, on waiting list. Patient #3: 45 F, 6 years of neck pain with right brachialgia, with right C5 dermatome signs, with MRI findings of C5/6 central disc herniation with cord compression, undergoing C5/6 Bryan TDA in December 2000, with FU MRI showing after 5 years and 7/12 (67/12) new C6/7 canal narrowing with right C6 radiculopathy, and treatment recommendation of C6/7 Bryan TDA. Patient #4: 38 M, worsening gait over 5 years and exam findings of progressive cervical myelopathy, with MRI findings of severe C5/6 disc degeneration with spinal cord compression, undergoing C5/6 Bryan TDA in August 2003, with FU MRI showing after 3 years new C4/5 disc prolapse with C5 radiculopathy, followed by treatment recommendation of C4/5 Bryan TDA. Discussion & Conclusions: Bryan TDR did not prevent the development of accelerated ASD. Evidence from in vivo X ray studies suggested that the range of motion across the operated levels did not match the physiological ROM. Despite the MRI images preoperatively, it is difficult to exclude the natural progression of degeneration as a reason for ASD


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 57 - 57
1 Apr 2017
Aragonés M Hevia E Caballero A Barrios C
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Background. The controversy concerning the benefits of unisegmental cervical disc arthroplasty (CDA) over anterior cervical discectomy and fusion (ACDF) is still open because some randomised clinical trial (RTC) comparing ACDF with CDA have been highly inconclusive. Most of these studies mixed disc prosthesis with dissimilar kinematic characteristics. To date, a compilation of the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) compared with a single cervical disc arthroplasty (CDA) design, the Bryan disc has partially accomplished. Methods. This is a systematic review of RCTs with level I-II evidence. Only RCTs reporting clinical outcomes were included in this review. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of total 51 studies were entered in the study. RTC's were searched from the earliest available records in 2005 to December 2014. Results. Five studies were Level I, and five were Level II. Out of a total of 1101 patients, 562 patients were randomly assigned into the Bryan arthroplasty group and the remaining 539 patients into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing CDA had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with Bryan CDA had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level were slightly higher in patients with ACDF, showing no statistically significant difference. Conclusions. This review of evidence level I-II RCTs comparing clinical and radiological outcomes of patient undergoing Bryan arthroplasty or ACDF indicated a global superiority of the Bryan disc. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and Bryan arthroplasty. These data suggest that even though the loss of motion has a determinant influence in the development of degenerative changes in ACDF cases, these kinematic factors do not imply a higher rate of symptomatic adjacent segment degeneration requiring surgery. Level of Evidence. Level I


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 410 - 410
1 Sep 2005
Tan L Cochrane N
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Introduction The use of unconstrained artificial cervical disc replacement (specifically the Bryan ® prosthesis) allows maintenance of normal cervical motion (unlike conventional fusion techniques) with the goal of alleviating neck and arm pain associated with spondylotic radiculopathy. As a relatively new technique, there is little in the literature regarding patient satisfaction with this device and there are no long term trials defining the most appropriate indication for this device nor benefits over alternative and more conventional procedures such as discectomy and fusion. This study aimed to quantify the degree of disability and functional limitation in patients selected for Bryan disc replacement both pre-operatively and from 3 months post-operatively. Methods The Oswestry Disability Index (ODI) and the SF36 Index were both used, being robust and reproducible tools in this setting. Patients completed questionnaires pre-operatively and from 3 months post-operatively. From 1 to 3 Bryan disc prostheses were implanted in the cervical spine at each operation. Post-operative index scores were compared with the pre-operative scores for 45 patients who completed all questionnaires, from a total of 47 operated patients in one practice (97% response, 69 total implants). Results Patients reported a decrease in measured disability and an increase in general functioning and wellbeing after Bryan cervical disc replacement. Where 100% represents total and complete disability, the mean ODI improved from 43.65% pre-operatively (95% confidence interval 37.9 – 49.4) to 19.4% (14.0 – 24.9) post-operatively. Where 100% represents full and limitless functioning, the mean SF36 improved from 42.7% pre-operatively (36.7 – 48.6) to 64.9% (57.7 – 72.0) post-operatively. All the results were significant (p value < 0.05). Discussion After single and multiple level Bryan cervical disc replacements in the cervical spine, there is significant decrease in perceived disability and pain as well as improvement in functional ability when compared to the pre-operative status of these patients. It is proposed that if undertaking cervical discectomy, maintenance of normal cervical motion where possible correlates with higher patient satisfaction when compared to more conventional cervical discectomy techniques


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 461 - 461
1 Apr 2004
Sears W
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Introduction: While anterior cervical decompression and fusion has been shown to be clinically effective in cases of myelopathy or radiculopathy, several studies have suggested an increased risk of development of adjacent segment degeneration. The Bryan Cervical Disc Pros-thesis was developed to address this complication and was fi rst used clinically in Europe in January 2000. The author began to use the device in June of 2001 and since that time has implanted 30 prostheses in 22 patients. The present prospective study was commenced at the time (concurrently with an ASERNIPS study) with a view to examine the clinical efficacy and safety of this device. The results in the author’s first 14 patients are reported, all with a minimum follow-up of 12 months (mean 20 months). Methods: An observational audit of 14 consecutive patients with cervical radiculopathy (6 patients), myelopathy (6 patients) or discogenic neck pain (2 patients) operated upon between July 2001 and November 2002. Average age was 48 years (range 27 – 61 years). 5 patients underwent two level procedures. Operative / post-op complications and clinical / radiological outcomes were recorded at 6 weeks, 3, 6, 12 months and January 2004. Results: Follow-up data is available at > 12 months on 13 of the 14 patients at an average 23 months post op (Range: 14–30 months). The patient for whom data is not available is known to have had a poor clinical outcome. She developed an unusual symptom complex with complex regional pain syndrome and is very unhappy with the surgery. Of the other 13 patients, 12 consider their outcome to have been excellent and 1 fair. In the two patients who underwent surgery purely for discogenic neck pain, substantial relief was reported. In the 8 patients with pre-operative arm pain, 6 reported complete relief, 1 substantial relief and one partial relief. There were no intra-operative complications. Two patients developed dysphagia which resolved after several months, one has described a clicking sensation in his neck for which no cause has been identified and one experiences persistent ‘neural surges’. One patient required surgery for a disc herniation at an adjacent level, 9 months post-op while in another patient, on routine 12 month follow-up MRI scan, an asymptomatic disc herniation adjacent to the operated segment had resolved spontaneously. One patient underwent foraminotomy for recurrent arm pain, 19 months post-op. All prostheses appear mobile on dynamic x-rays but it is apparent that the Bryan device does not correct any pre-operative degenerative deformity using the current technique. Discussion: The current study appears to indicate satisfactory clinical outcomes at an average of 23 months post surgery in this group of patients. Longer follow-up and larger patient numbers are required as well as comparative studies


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 411 - 411
1 Sep 2005
Sears W Sekhon L Duggal N McCombe P Williamson O
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Introduction The early clinical results of cervical disc replacement surgery are encouraging but the in vivo kinematics of prostheses remains poorly understood. Two recent published reports suggest that use of a prosthesis with an unconstrained (over normal range of motion) biconvex nucleus (Bryan Cervical Disc® – Medtronic Sofamor Danek, Memphis, TN) can be associated with post-operative segmental kyphosis. This study examines post-operative kyphosis and segmental imbalance following cervical disc replacement using the Bryan Cervical Disc prosthesis and factors which may influence this. In particular, the influence of change in disc space height as a result of surgery was studied. Methods 67 patients underwent prosthetic disc replacement by one of three surgeons (19, 25 and 23 patients, respectively) using the Bryan prosthesis. 46 single, 20 double and 1 triple level were operated. Neutral pre- and post-op erect and intra-operative x-rays were examined manually and using digital image analysis software (Medical Metrics, Inc. Houston, TX). Possible contributing factors to segmental alignment were studied including: pre-op alignment, angle of prosthesis insertion, disc space degeneration and sacrifice of the posterior longitudinal ligament (PLL). Particular attention was given to changes in disc space height and factors which may influence this. Inter- and intra-observer agreement was assessed. Non-parametric tests were used for assessment of categorical and skewed continuous variables. Multivariate linear regression was used to adjust significant correlation coefficients. Significance was set at p< 0.05. Results The median pre-op focal lordosis of +0.5° (range: 21 to −14°, −ve = kyphotic) changed by −1° (+14 to −17°), to post-op: 0° (+11.5 to −16°). There was a significant difference in the median change in focal lordosis for surgeon 1 (−3°) vs. surgeons 2 & 3 (−1°) (p< 0.005) and in the loss of disc space height. Median loss of disc space height for surgeon 1 was 22% vs. 8% for surgeons 2 & 3 (p< 0.002). Correlation co-efficient (Spearman) for change in disc space height vs. change in disc space angulation was 0.67 (p< 0.0001). No single pre- or intra-operative factor was found to clearly correlate with subsequent loss of disc space height apart from a trend towards a weak correlation with the angle of prosthesis insertion (r=0.24, p=0.06). Discussion The median change (loss) in focal lordosis was −1.5° but there was considerable range: from +14° to −17°. Attempts to identify contributing factors suggest that a number may be involved but there did appear to be a highly significant correlation between loss of disc space height following surgery and subsequent focal kyphosis. While the difference in outcomes between Surgeon 1 and Surgeons 2 & 3 is probably not clinically significant, it does suggest that intra-operative factors such as the angle of prosthesis insertion may be important. We are continuing to study these factors


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 330 - 330
1 Nov 2002
Lafuente JD Casey ATH Singh. A
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Objective: To assess the safety and efficacy of a novel Artificial Cervical Disc. Design: Compare the Bryan prosthesis to Anterior Cervical Discectomy and Fusion (ACDF), by using the pre-defined objective performance criteria (OPC) derived from a literature meta-analysis of ACDF in which a success rate of 73% was established. The Null hypothesis is that the success rate for the Bryan prosthesis is greater or equal to the OPC (Objective Performance Criteria) of 85%. Secondary Objectives studied included the range of motion after implantation; adverse events from implantation onwards; maintenance of the disc space height; amount of subsidence. Radiology was assessed by an independent radiologist. Improvement in the quality of life for the patient (SF-36) was also recorded at six weeks, six months and one year. Data was collected by an independent research practitioner. Subjects: Multicentre study seven European centres: 107 patients Male 51, Female 66. Age ranged from 27 to 71. Mean age was 42 years with a clinical diagnosis of cervical radiculopathy or myelopathy, and single level disc disease on MRI. Outcome Measures: Odom Criteria, SF-36, radiological range of movement. Results: The Bryan Cervical Disc was associated with a clinical success according to Odom’s criteria of 87%. Radiological success occurred in 97%. SF-36 analysis revealed a statistically significant improvement in all domains. Conclusion: The Bryan Disc has been successfully implanted in 107 patients with good clinical results and at one-year follow-up there is radiological evidence of preserved motion


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 266 - 266
1 Mar 2013
Miyoshi N Suenaga N Oizumi N Inoue K Ito H
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Introduction. Although Total elbow arthroplasty (TEA) generally provides favorable clinical outcomes, its complications have been reported with high rate compared with other joints. Previously, we used the Bryan & Morrey approach in TEA, which included separating the triceps muscle subperiosteally from the olecranon; however, since 2008, in order to prevent skin trouble and deficiency of the triceps, we performed TEA by MISTEA method, which required no removal of the subcutaneous tissue in the region of the olecranon and no release or stripping of the triceps tendon. Objectives. The purpose of this study was to examine the utility of the MISTEA method by evaluating and comparing muscle strength and complications by using both the Bryan & Morrey approach and MISTEA method. Materials and Methods. The study was conducted on 23 elbows, on which elbow muscle strength could be measured postoperatively at more than 6 months after TEA. Thirteen elbows were operated on the Bryan & Morrey approach (BM group; mean age, 62.3 years; mean follow-up period, 27 months), and 10 elbows on the MISTEA method (MIS group; mean age, 67.6 years; mean follow-up period, 19.1 months). To determine the elbow extensor and flexor strengths, measurements were conducted on the affected side for the BM group, and on both the affected and healthy sides for the MIS group. Further, the “extension/flexion ratio” as well as the “affected/healthy side ratio” and complications were assessed. Results. Excluding the elbow extensor strength of 3 elbows in the BM group, which could not be measured too week. The extension/flexion ratio was as follows: in the BM group, 0.61 and in the MIS group, 0.93 on the affected side and 0.81 on the healthy side. For the MIS group, in which measurements could be performed on both the sides, the “affected/healthy side ratio” was 0.72 in flexion and 0.91 in extension. In terms of complications, skin trouble was found on 2 elbows in the BM group and on 1 elbow in the MIS group; further, rupture of the triceps tendon was suspected in 3 elbows in the BM group but was not found in the MIS group. Discussion. In our study, deficiency in triceps muscle was found in 3 of 13 elbows with the Bryan & Morrey approach. MISTEA method may be the reason for prevention of deficiency or rupture of the triceps tendon. The MIS group had higher extension/flexion ratio in the affected side, suggesting the possibility that either the extensor strength had increased or the flexor strength had weakened. Further, in the MIS group, the extension showed an “affected/healthy side” ratio, which means that an extensor strength almost equivalent to that of the healthy side was maintained, whereas the flexor strength was 72% of that on the healthy side, suggesting that the flexor strength may have decreased. Loss of the flexor strength may be because the MISTEA method involves partial release of the brachialis muscle and the joint's center of rotation to move slightly towards the proximal side


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 262 - 262
1 Sep 2005
Harty JA Butt K Bryan K Mullan GB
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Polymethylmethacrylate (PMMA) Acrylic Bone Cement is a polymer used to anchor the prosthesis during Joint Replacement Surgery. Arthroplasty with Bone Cement is associated with late loosening, compromising prosthetic stability leading to Revision arthroplasty. Different irrigating solutions such as Hydrogen Peroxide or Saline are used during arthroplasty. The aim of the study was to analyse the effects of Hydrogen Peroxide on the mechanical properties of Bone Cement.

Materials and Methods: Cement was mixed as per standard methods used in theatre, in a vacuum and at a temp of 18 degrees centigrade. Once the cement was mixed it was then placed in conical moulds and the exposed surface was either exposed to saline or Hydrogen Peroxide solution (6% from a standard theatre preparation). We studied the effect of Hydrogen Peroxide on Dough time, Curing time, Surface Analysis and Hardness of PMMA. Dough time was performed with latex examination gloves. Curing time was measured at 15 seconds intervals using a Vickers hardness transistor. Cement hardness was assessed using the same machine. Surface analysis was performed by preparing the samples using a grit rotaforce machine. Palacos Bone Cement was used and tests were conducted according to ASTM F-451 and ISO 5833 standards.

Results: The samples exposed to hydrogen peroxide showed an increase in the dough time in comparison to the controls from 3.5 minutes to 5 minutes. Curing time showed a difference of 13.5 minutes for the controls as opposed to 17 minutes for the HP contaminated samples. Surface hardness reduced from a mean of 17.5hv to 14.3hv after exposure to hydrogen peroxide (p< 0.05). There was increased staining of the Hydrogen Peroxide sample, with surface irregularities, and an associated increase in surface porosity. Surface porosity increased from 120um (SD 11.2) to 180um (SD 8.7) (p< 0.05).

Conclusion: We have shown that the use of hydrogen peroxide contamination of bone cement interferes with the biomechanical properties of the cement, leading to an overall reduction in strength and hardness of the cement. This may lead to an associated reduction in the strength of the bone cement interface and precipitate early micro-motion and loosening of the prosthesis.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIV | Pages 34 - 34
1 Jul 2012
Modi C Hill C Saithna A Wainwright D
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Trans-articular coronal shear fractures of the distal humerus pose a significant challenge to the surgeon in obtaining an anatomical reduction and rigid fixation and thereby return of good function. A variety of approaches have been described which include the extended lateral and anterolateral approaches and arthroscopically-assisted fixation for non-comminuted fractures. Fixation methods include open or percutaneous cannulated screws and headless compression screws directed either anterior to posterior or posterior to anterior. We describe an illustrated, novel approach to this fracture which is minimally invasive but enables an anatomical reduction to be achieved. A 15 year old male presented with a Bryan and Morrey type 4 fracture as described by McKee involving the left distal humerus. He was placed in a lateral position with the elbow over a support. A posterior longitudinal incision and a 6cm triceps split from the tip of the olecranon was made. The olecranon fossa was exposed and a fenestration made with a 2.5mm drill and nibblers as in the OK (Outerbridge-Kashiwagi) procedure. A bone lever was then passed though the fenestration and used to reduce the capitellar and trochlear fracture fragments into an anatomical position with use of an image intensifier to confirm reduction. The fracture was then fixed with two headless compression screws from posterior to anterior into the capitellar and trochlear fragments (see images). Early mobilisation and rehabilitation were commenced. Follow-up clinical examination and radiographs at six weeks revealed excellent range-of-motion and function with anatomical bony union. We believe that this novel approach to this fracture reduces the amount of soft tissue dissection associated with conventional approaches and their associated risks and also enables earlier return to function with restoration of anatomy


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVII | Pages 49 - 49
1 May 2012
Munigangaiah S Cronin K McCabe J
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Background. There have been limited published reports on the clinical results of cervical artificial disc replacement. Goffin et al reported a 90% rate of good to excellent results at 1 to 2 yrs after Bryan disc replacement. Wigfield et al reported a 46% improvement in pain and 31% improvement in disability 2 yrs after Prestige cervical disc replacement. Objectives. The study was designed to determine whether new functional cervical disc prosthesis can provide improvement in the ability to perform activities of daily living, decrease pain and segmental motion. Methods. All patients who had Prestige cervical disc replacement over last 2yrs 3 months were identified. Oswestry disability index score and SF36 Quality of life instrument were administered to each patient. Site specific pain scores were obtained using visual analogue scale. Clinical and operative details were reviewed and correlated. Results. 35 Patients underwent 48 Prestige cervical disc replacement during study period. There was 48%, 54% and 70% improvement in Oswestry disability index at 6 weeks, 6 months and 19 months follow-ups respectively. There was significant improvements in both neck and arm pain during immediate post op period and during further follow-ups. There was one neck wound haematoma and one left sided Horner's syndrome as complications. Conclusion. Anterior cervical disc replacement is a viable surgical alternative to fusion for cervical disc degenerative disease and herniation with preservation of motion and alignment without compromising clinical outcomes. At least 5yrs follow-up will be needed to assess the long term functionality of the prosthesis and protective influence on the adjacent levels


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_2 | Pages 27 - 27
1 Feb 2015
Whitehurst D Bryan S Lewis M Hay E Mullis R Foster N
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Purpose and background

To explore the cost-utility of implementing stratified care for low back pain (LBP) in general practice, compared with usual care, within patient risk subgroups (low, medium and high risk of persistent disabling pain determined by the STarT Back tool).

Methods

Adopting a cost-utility framework alongside a prospective, sequential comparison of separate patient cohorts (922 patients in total) with six-month follow-up, the base case analysis estimated the incremental LBP-related healthcare cost per additional quality-adjusted life year (QALY) by risk subgroup. Uncertainty was explored with cost-utility planes and acceptability curves. Sensitivity analyses examined alternative approaches (a complete case analysis, the incorporation of non-LBP-related healthcare use and estimation of societal costs relating to work absence).


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 166 - 166
1 Mar 2010
Egan C Egan R Curran P Bryan K Fleming P
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Aims: The distal radius fracture model prototype has been produced as a means for teaching reduction of a distal radius fracture. In this study we aim to test the repeatability and reproducibility of the force required to correct the shortening of the radius. In addition a questionnaire was carried out to assess face validity

Methods and materials: The distal radius fracture model prototype has been designed and manufactured to simulate reduction of a dorsally displaced, radially angulated, shortened fracture of the distal radius. We designed a mounting rig for the model and used a Hounsfield tensometer to measure the degree of movement of the distal fracture fragment when various degrees of force were applied. Force was applied to reproduce correction of radial shortening. Reproducibility was tested by resetting of the tensioning device at the rear of the model. The questionnaire was constructed using a series of 5 point, verbally anchored Likert items.

Results: Mean force required for reduction was 191.4 N (Newton) (range 189.4 – 193.4N). Standard deviation for repeated measurement was 1.65 N. Graphs of force versus extension showed one consistent point of slippage which could be explained by movement in the spring tensioner for distal radial displacement. On repeated testing the model tensioning device also showed good reproducibility of results. The results for face validity showed that most people rated the model as having an appearance consistent with that of a fractured distal radius (median score for appearance 4.7, tactile propertied 4.7) but that the biomechanical properties of the reduction were not scored as highy (median score 3.9) The median score when asked about the usefulness of the model for teaching junior staff was high (4.52)

Conclusions: This prototype produces repeatable performance parameters on reduction of the fracture. Overall experience with the prototype is good but it requires further refinement.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 447 - 447
1 Aug 2008
Jayakumar P Casey A Leung C
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Background: The phenomenon of heterotopic ossification (HO) is a well-known complication of joint replacement surgery. However, the clinical associations and effects of HO in cervical arthroplasty are unclear. This study investigates the incidence of HO in cervical disc replacement, identifies potential associated risk factors, and assesses the relationship of HO with clinical outcomes. Method: The patient population (n=90; 39 men, 51 women; mean age 45 years; range 26–79 yr; standard deviation, 9.8 yr) was acquired from the original multi-center, prospective, observational Bryan Disc Study by the European Consortium. The presence of HO was defined in accordance with the McAfee classification based on cervical lateral x-rays at 12 months post surgery and interpreted by an independent neurosurgeon and a radiologist. Secondary outcome measurements included Odom’s criteria and the Medical Outcomes Study Short-Form 36-Item Health Survey. Results: 16 out of the total 90 patients (17.8%) experienced HO. 6 patients (6.7%) experienced Grade 3 and 4 HO. 10 patients’ (11%) artificial discs demonstrated movement of less than 2 degrees on flexion and extension cervical x-ray at 12 months post-operatively. 4 of these patients had HO of Grade 3 or 4. Male sex ([chi]. 2. = 4.1; P = 0.0407) and older patients (P = 0.023; odds ratio = 1.10; 95% confidence interval = 1.01–1.19) were associated with development of HO. Discussion: HO is known to restrict movement of large joint and lumbar disc replacements. Our study demonstrates male sex and older age as potential risk factors in development of HO after cervical disc arthroplasty. There is a strong association between HO and subsequent loss of movement of implanted cervical artificial discs. Failure to preserve motion may expedite the onset of symptomatic adjacent segment level disease making this an important complication requiring further investigation. Grade 3 or 4 HO limited movement in 4.4% of patients


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 134 - 134
1 Mar 2010
Chung S Lee C Yu J
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Anterior decompression and fusion has been standard treatment for cervical disc herniation and myelopathy with disc degeneration. Since cervical total disc replacement (TDR) has been introduced with early favorable results and ideal mechanism, it has gained its popularity recently. But varying degrees of heterotopic ossification (HO) around the operated segment have been noted in the literatures. The theoretical advantages of TDR are the maintenance of intervertebral motion and prevention of adjacent segment degeneration. It is questionable that if HO occurs after TDR, mobility of operated segments would be restricted then clinical outcome worse. Purpose of this study is to determine prevalence of HO and to investigate that the presence of HO would limit motion and subsequently negatively affect clinical outcome following cervical TDR. We analyzed 29 patients (30 levels) who were treated with cervical TDR by 2 spine specialists using 4 types of prostheses (Mobi-C: 13 levels, ProDisc: 10, Bryan: 5, Prestige LP: 2) consecutively from July 2004 to June 2007. Postoperative mean follow-up period was 21.4 (12–36) months. We assessed presence of HO and segmental ROM radiographically and clinical outcome by VAS, ODI after 1.5, 3, 6 months, and every year postoperatively in principle. All subjects were divided by 3, which were group A (no HO, McAfee class 0), group B (class I and II), and group C (class III and IV), then compared with each other. HO was detected on 14 levels (46.7%) in the 30 levels after at mean of 8.2 (4–18) months after operation. There were 15 levels(53.3%) of group A (no HO, class 0), 7 levels of group B (class I HO:3, II: 4), and 7 levels of group C (class III: 3, IV: 4). Segmental flexion-extension ROM of group A was 10.1 (5.6–16.2)°, group B is 8.3 (3.5–14.4)°, and group C is 3.1 (0.0–6.6)° (p< 0.001, multiple comparison test with post hoc Bonferroni correction). And no difference in the clinical outcomes, VAS and ODI, was found compared with each other among group A, B, and C (p> 0.05). Nonetheless, longer term follow-up should be performed to investigate whether clinical outcomes would be changed and occur adjacent level degeneration as time goes on. In addition, further study for prevention of HO may be needed as in HO of other joint replacement surgery not to lose superior mechanism to fusion treatment


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 455 - 456
1 Oct 2006
Pimenta L Scott-Young M Cappuccino A McAfee P
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Introduction This is a prospective, consecutive series of 178 prosthetic implantations to analyse single level versus multiple level cervical arthroplasty with two years minimum follow-up. Methods Fifty-five patients underwent a total of fifty-five Porous Coated Motion (PCM) cervical arthroplasties from C3–4 to C7–T1 (Group S for single level). Fifty-four patients underwent one hundred and nine multilevel PCM cervical arthroplasties (Group M for multilevel) during the same time interval, for the same indications, performed by the same surgeons under the same clinical protocol— double level, 43 cases; three levels, 7 cases: and four levels, 4 cases. Sixteen PCM cases had been performed as complex revision procedures with prior fusions—9 in Group S and 7 in Group M. They included 1 previous Bryan Disc, 1 cage-plate, 1 patient with Klippel-Feil disease, 3 patients had failed lordotic cervical cages. One additional patient in Group M had a fracture-dislocation at C4–5 with a pseudarthrosis at C3–4 and C5–6. The demographics between Group S and Group M were very similar—mean age of patients, gender, severity of neurologic symptoms and distribution of radicular and myeloradicular symptoms. Results There were no deaths, no infections, and no instances of iatrogenic neurologic progression in either the single level or the multiple level arthroplasty group. The mean EBL, length of surgery, and length of hospital stay were greater for the Multilevel Group. In contrast to these three operative demographic statistics, the self assessment outcomes instruments consistently showed more improvement for the multilevel cases. The mean improvement in the NDI for the single cases was 54.8 % (+/− 20.9) versus the multilevel cases mean improvement in NDI was 64.8 % (+/− 33.7). The mean improvement in the VAS showed the same relationship—single level mean improvement 62.0 % (26.9) versus the multilevel cases mean VAS improvement was 68.1% (+/− 31.4). The SF-36, Odoms, and TIGT were also more improved for the multilevel versus the single level group. The reoperation rates, adverse events, and incidence of complications were the same between the single level to the multilevel arthroplasty groups. Discussion This prospective report of cervical arthroplasty demonstrates that each cervical vertebral level is biomechanically independent of the adjacent level, whether it contains an arthoplasty or an unoperated intervertebral disc. With the Porous Coated Motion cervical arthroplasty the incidence of reoperation did not increase proportionately higher as the number of cervical levels requiring instrumentation increased. Even in three and four level arthroplasty the true benefits of cervical disk replacement outcomes were demonstrated on functional clinical outcomes at minimum two-year follow-up


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 59 - 59
1 Jan 2004
Delattre O Dintimille H Gottin M Rouvillain J Catonne Y
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Purpose: Loosening remains a problem with semi-constrained total elbow prostheses. The trend in recent years has been to improve prosthesis design to achieve stability of the humeral implant. We report a small series of nine Coonrad-Morrey total elbow prostheses where three early loosenings were observed in the ulnar implant. We attempt to analyse the causes and present a review of the recent literature. Material and methods: Nine patients, mean age 60 years, age range 57–63 years, underwent total elbow arthroplasty with a Coonrad-Morrey prosthesis for rheumatoid disease (n=5), stiff degenerative joints after trauma (n=3, flexion-extension 20°), floating joint after trauma (n=1). The posterolateral approach described by Bryan and Morrey was used for eight elbows and the posterior approach for one. Clinical and radiological results were assessed with the performance index and the Mayo clinic score respectively. Results: Mean follow-up was 3.6 years (1.5–4.7). Outcome was very good or good for seven elbows (score > 75 and > 50), fair for one (< 50) and poor for one (< 25). Three elbows were pain free, two presented pain during movement against force. Flexion was greater than 120° in four elbows (all four rheumatoid polyarthritis). Radiologically, we observed three cases of ulnar implant loosening with two type IV lucent lines, and one type III line. There was one humeral implant with a lucent line which did not change over time (type I). The two cases of type IV lines were associated with radial and anterior translation migration of the prosthetic stem with effraction or lysis of the ulnar cortical. The three ulnar loosenings appeared between the second and third postoperative year on two post-trauma stiff degenerative elbows (flexion-extension < 20°) and one rheumatoid elbow. At last follow-up, there was one poor result requiring revision surgery, one fair result, and one very good result (totally asymptomatic type 4 lucent line). Discussion: The causes of these loosenings were studied: difficult cementing technique in a tight canal, mediocre primary stability of the ulnar implant opposing the excellent fit of the humeral implant with an encased graft under the anterior wing, excessive constraint. Our results are similar to those reported by Hilebrand who had 30% evolving ulnar lucent lines and suggest that we should reserve this prosthesis for unstable elbows


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 28 - 28
1 Jan 2013
Hill J Whitehurst D Lewis M Bryan S Dunn K Foster N Konstantinou K Main C Mason E Somerville S Sowden G Vohora K Hay E
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Background

One untested back pain treatment model is to stratify management depending on prognosis (low, medium or high-risk). This 2-arm RCT investigated: (i) overall clinical and cost-effectiveness of stratified primary care (intervention), versus non-stratified current best practice (control); and (ii) whether low-risk patients had non-inferior outcomes, and medium/high-risk groups had superior outcomes.

Methods

1573 adults with back pain (+/− radiculopathy) consulting at 10 general practices in England responded to invitations to attend an assessment clinic, at which 851 eligible participants were randomised (intervention n=568; control n=283). Primary outcome using intention-to-treat analysis was the difference in change in the Roland-Morris Disability Questionnaire (RMDQ) score at 12 months. Secondary outcomes included 4-month RMDQ change between arms overall, and at risk-group level at both time-points. The economic evaluation estimated incremental quality-adjusted life years (QALYs) and back pain-related health care costs.