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Bone & Joint Open
Vol. 4, Issue 7 | Pages 539 - 550
21 Jul 2023
Banducci E Al Muderis M Lu W Bested SR

Aims. Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach. Methods. A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications. Results. A total of 19 studies were included: four one-stage, 14 two-stage, and one article with both one- and two-stage groups. Superficial infection was the most common complication (one-stage: 38% vs two-stage: 52%). There was a notable difference in the incidence of osteomyelitis (one-stage: nil vs two-stage: 10%) and implant failure (one-stage: 1% vs two-stage: 9%). Fracture incidence was equivocal (one-stage: 13% vs two-stage: 12%), and comparison of soft-tissue, stoma, and mechanical related complications was not possible. Conclusion. This review suggests that the one-stage approach is favourable compared to the two-stage, because the incidence of complications was slightly lower in the one-stage cohort, with a pertinent difference in the incidence of osteomyelitis and implant failure. Cite this article: Bone Jt Open 2023;4(7):539–550


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 92 - 92
1 Dec 2022
Thibault J Grammatopoulos G Horton I Harris N Dodd-Moher M Papp S
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In patients admitted to hospital with a hip fracture, urinary issues are common. Despite guidelines that recommend avoiding foley catheter usage when possible, it remains a common part of perioperative care. To date, there is no prospective data on the safety and satisfaction associated with catheter use in such cohort. The aim of this study was to evaluate the satisfaction of patients when using a foley catheter while they await surgery for their fractured hip and the safety associated with catheter use. In our prospectively collected database, 587 patients were admitted to our tertiary care center over a 1 year period. Most patients (328) were catheterized within the first 24h of admission, primarily inserted in ED. Of these patients, 119 patients (61 catheterized and 58 noncatheterized) completed a questionnaire about their perioperative management with foley catheter usage administered on day 1 of admission. This was used to determine satisfaction of catheter use (if catheterized) and pain levels (associated with catheterized or associated with transferring/voiding if not catheterized). Adverse effects related with catheter use included urinary tract infection (UTI) and post-operative urinary retention (POUR). Ninety-five percent of patients found the catheter to be convenient. Only 5% of patients reported any pain with catheter use. On the contrary, 47.5% of non-catheterized patients found it difficult to move to the bathroom and 30.4% found it difficult to urinate. Catheterized patients had significative less pain than uncatheterized patients (0.62/10 vs 2.45/10 respectively, p < 0 .001). The use of nerve block reduced pain levels amongst catheterized patients but was not associated with reduced pain levels or satisfaction amongst non-catheterized patients. The use of catheter was not associated with increased risk of UTI(17.5% in the catheterized vs 13.3% in the non-catheterized, p = 0.541) or POUR (6.8% in the catheterized vs 11.1% in the non-catheterized, p = 0.406). This study illustrates the benefits and safety associated with the use of urinary catheters in the pre-operative period amongst hip fractures. The use of catheters was associated with reduced pain and satisfaction without increasing post-operative UTI or POUR. These findings suggest that pre-operative catheter use is associated with less pain and more satisfaction for patients awaiting hip surgery and whom other measures, such as nerve blocks, are unlikely to reduce the discomfort associated with the mobility required to void. A prospective randomized control study could lead to a more evidence based approach for perioperative foley catheter usage in hip fracture patients


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 29 - 29
10 May 2024
Stowers M Rahardja R Nicholson L Svirskis D Hannam J Young S
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Introduction. Day stay surgery for anterior cruciate ligament (ACL) reconstructions is an increasingly common practice and has driven clinicians to come up with postoperative pain regimes that allow same day mobilisation and a safe and timely discharge. There is a paucity of literature surrounding the use of intraosseous (IO) ropivacaine used as a Bier's block to provide both intraoperative and postoperative analgesia in lower limb surgery. Methods. This patient blinded, pilot study randomised 15 patients undergoing ACL reconstruction to receive either IO ropivacaine 1.5 or 2.0 mg/kg; or 300 mg of ropivacaine as local infiltration (standard of care). Toxic plasma levels of ropivacaine have been defined in the literature and therefore the primary outcome for this study was arterial plasma concentration of ropivacaine as a means to determine its safety profile. Samples were taken via an arterial line at prespecified times after tourniquet deflation. Secondary outcomes that we were interested in included immediate postoperative pain scores using the visual analogue scale (VAS) and perioperative opioid equivalent consumption. Results. Participants had a mean age of 27.8 (SD 9.2) years and 87% (13/15) were male. All patients in the intervention group receiving IO ropivacaine had plasma concentrations well below the threshold for central nervous system (CNS) toxicity (0.60 µg/ml). The highest plasma concentration was achieved in the intervention group receiving 1.5 mg/kg dose of ropivacaine reaching 3.59 mg/ml. This would equate to 0.22 µg/ml of free plasma ropivacaine. There were no differences across the three groups regarding pain scores or perioperative opioid consumption. Conclusions. This study demonstrates that IO administration of 0.2% ropivacaine is both safe and effective in reducing perioperative pain in patients undergoing ACL reconstruction. There may be scope to increase the IO dose further or utilise other analgesics via the IO regional route to improve perioperative pain relief


Bone & Joint Open
Vol. 1, Issue 8 | Pages 450 - 456
1 Aug 2020
Zahra W Dixon JW Mirtorabi N Rolton DJ Tayton ER Hale PC Fisher WJ Barnes RJ Tunstill SA Iyer S Pollard TCB

Aims. To evaluate safety outcomes and patient satisfaction of the re-introduction of elective orthopaedic surgery on ‘green’ (non-COVID-19) sites during the COVID-19 pandemic. Methods. A strategy consisting of phased relaxation of clinical comorbidity criteria was developed. Patients from the orthopaedic waiting list were selected according to these criteria and observed recommended preoperative isolation protocols. Surgery was performed at green sites (two local private hospitals) under the COVID-19 NHS contract. The first 100 consecutive patients that met the Phase 1 criteria and underwent surgery were included. In hospital and postoperative complications with specific enquiry as to development of COVID-19 symptoms or need and outcome for COVID-19 testing at 14 days and six weeks was recorded. Patient satisfaction was surveyed at 14 days postoperatively. Results. There were 54 females and 46 males (mean age 44 years, mean body mass index (BMI) 25.6 kg/m. 2. ). In all, 56 patients underwent major orthopaedic procedures. There were no exclusions. One patient had a postoperative positive SARS-CoV-2 RT-PCR test but had no typical symptoms of COVID-19 infection and no clinical sequelae. 99% of patients were satisfied with the process and 98% would recommend undergoing elective orthopaedic surgery in the study period. Conclusion. In an environment with appropriate infrastructure, patient selection, isolation, screening, and testing, elective orthopaedic surgery is safe during the COVID-19 pandemic, and associated with high patient satisfaction. Further follow-up is required to establish that safety is maintained as the clinical restrictions are eased with the phased approach described. Cite this article: Bone Joint Open 2020;1-8:450–456


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 88 - 88
10 Feb 2023
Seth I Bulloch G Seth N Fogg Q Hunter-Smith D Rozen W
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The trapeziometacarpal joint (TMCJ) is the most common hand joint affected by osteoarthritis (OA), and trapezium implant arthroplasty is a potential treatment for recalcitrant OA. This meta-analysis aimed to investigate the efficacy and safety of various trapezium implants as an interventional option for TMCJ OA. Web of Science, PubMed, Scopus, Google Scholar, and Cochrane library databases were searched for relevant studies up to May 2022. Preferred Reported Items for Systematic Review and Meta-Analysis guidelines were adhered to and registered on PROSPERO. The methodological quality was assessed by National Heart, Lung, and Blood Institute tools for observational studies and the Cochrane risk of bias tool. Subgroup analyses were performed on different replacement implants, the analysis was done via Open Meta-Analyst software and P values < 0.05 were considered statistically significant. A total of 123 studies comprising 5752 patients were included. Total joint replacement (TJR) implants demonstrate greater significant improvements in visual analogue scale pain scores postoperatively. Interposition with partial trapezial resection implants was associated with the highest grip strength and highest reduction in the Disabilities of the Arm, Shoulder, and Hand score. Revision rates were highest in TJR (12.3%), and lowest in interposition with partial trapezial resection (6.2%). Total joint replacement and interposition with partial trapezial resection implants improve pain, grip strength, and DASH scores more than other implant options. Future studies should focus on high-quality randomized clinical trials comparing different implants to accumulate higher quality evidence and more reliable conclusions


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 89 - 89
7 Nov 2023
Greenwood K Molepo M Mogale N Keough N Hohmann E
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The posterior compartments of the knee are currently accessed arthroscopically through anterior, posteromedial or posterolateral portals. A direct posterior portal to access the posterior compartments has been overlooked due to a perceived high-risk of injury to the popliteal neurovascular structures. Therefore, this study aimed to investigate the safety and accessibility of a direct posterior portal into the knee. This cross-sectional study comprised a sample of 95 formalin-embalmed cadaveric knees and 9 fresh-frozen knees. Cannulas were inserted into the knees, 16mm from the vertical plane between the medial epicondyle of the femur and medial condyle of the tibia and 8 and 14mm (females and males respectively) from the vertical plane connecting the lateral femoral epicondyle and lateral tibial condyle. Landmarks were identified in full extension and cannula insertion was completed with the formalin-embalmed knees in full extension and the fresh-frozen in 90-degree flexion. Posterior aspects of the knees were dissected from superficial to deep, to assess potential damage caused by cannula insertion. Incidence of neurovascular damage was 9.6% (n=10); 0.96% medial cannula and 8.7% lateral cannula. The medial cannula damaged one small saphenous vein (SSV) in a male specimen. The lateral cannula damaged one SSV, 7 common fibular nerves (CFN) and both CFN and lateral cutaneous sural nerve in one specimen. All incidences of damage occurred in formalin-embalmed knees. The posterior horns of the menisci were accessible in all specimens. A medial-lying direct posterior portal into the knee is safe in 99% of occurrences. The lateral-lying direct posterior portal is of high risk to the CFN


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 60 - 60
1 Feb 2020
Kaper B
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Introduction/Aim. The NAVIO robotic-assisted TKA (RA-TKA) application received FDA clearance in May 2017. This semi-active robotic technique aims to improve the accuracy and precision of total knee arthroplasty. The addition of robotic-assisted technology, however, also introduces another potential source of surgery-related complications. This study evaluates the safety profile of NAVIO RA-TKA. Materials and Methods. Beginning in May 2017, the first 250 patients undergoing NAVIO RA-TKA were included in this study. All intra-operative complications were recorded, including: bleeding; neuro-vascular injury; peri-articular soft tissue injury; extensor mechanism complications; and intra-operative fracture. During the first 90 days following surgery, patients were monitored for any post-operative complications, including: superficial and deep surgical site infection; pin-tract infection; pin site fractures; peri-prosthetic fractures; axial or sagittal joint instability; axial mal-alignment; patello-femoral instability; DVT/PE; re-operation or re-admission due to surgical-related complications. Surgical technique and multi-modality pain management protocol was consistent for all patients in the study. A combined anesthetic technique was employed for all cases, including: low-dose spinal, adductor canal block and general anesthetic. Patients were mobilized per our institution's rapid recovery protocol. Results. No patients were lost to follow-up. During the study period, no intra-operative complications were recorded. Specifically, no complications related to the introduction of the high-speed burr associated with the NAVIO RA-TKA were noted. Within the 90-day follow-up period, there was one case of deep infection. One patient sustained a fall resulting in a peri-prosthetic femoral fracture, that occurred remote from the femoral pin tracts. No cases of axial or sagittal joint instability, axial mal-alignment, patello-femoral instability, pin site infections or fractures; or DVT/PE were identified. Four patients underwent manipulation under anesthesia. No other patients required a re-operation or re-admission due to surgical-related complications. Discussion/Conclusions. The initial experience with the NAVIO robotic assisted total knee arthroplasty has demonstrated excellent safety profile. Relative to known risks associated with total knee arthroplasty, no increased risk of peri-operative complications, re-operation or re-admission for surgical related complications was identified with the introduction of the NAVIO RA-TKA


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 29 - 29
1 Aug 2020
Wong I Oldfield M
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The primary objective of this study was to establish a safety profile for an all-arthroscopic anatomic glenoid reconstruction via iliac crest autograft augmentation for the treatment of shoulder instability with glenoid bone loss. Short-term clinical and radiological outcomes were also evaluated. This study involved a retrospective analysis of prospectively collected data for 14 patients (male 8, female 6) who were treated for shoulder instability with bone loss using autologous iliac crest bone graft between 2014 and 2018. Of 14 patients, 11 were available for follow-up. The safety profile was established by examining intra-operative and post-operative complications such as neurovascular injuries, infections, major bleeding, and subluxations. Assessment of pre-operative and post-operative Western Ontario Shoulder Instability (WOSI) index, radiographs, and CT scans comprised the evaluation of clinical and radiological outcomes. A good safety profile was observed. There was no occurrence of intraoperative complications, neurovascular injuries, adverse events, or major bleeding. One patient did develop an infection in the neurovascular injuries, adverse events, or major bleeding. One patient did develop an infection in the treated shoulder post-surgery. There were no subluxations or positive apprehension tests on clinical examination post-operatively. Short-term clinical outcomes were seen to be favorable WOSI scores at the most recent follow-up were significantly higher than pre-operative scores, with a mean increase of 39.6 ± 10.60 (p = 0.00055). The average follow-up for CT scan was 4.66 (SD± 2.33) months, where all patients showed bone graft union. Arthroscopic treatment of shoulder instability with bone loss via autologous iliac crest bone graft is shown to be a safe operative procedure that results in favorable short-term clinical and radiological outcomes. Further investigations must be done to evaluate the longevity of these positive health outcomes


Abstract. Background. ‘Free From Pain’ is a drug-free, injection injection-free, lifestyle-based musculoskeletal pain management programme for seniors. The programme empowers Seniors with relevant information and inspirational metaphors whilst providing them with validated exercises. The programme is also available as a published book (ISBN-0995676941). This pilot study aimed to assess the suitability and safety of the programme's exercises and the usefulness of the book before considering a larger study. Methods. Participants used 5-point Likert scales to evaluate the exercises. A rating of three or below on a Likert scale denoted non-agreement to a positive statement regarding the exercises. A rating of four or above denoted agreement. The Usefulness Scale for Patient Information Material (USE) was utilised to assess the book. Results. Of 30 participants who attended the programme, 25 completed the questionnaire (19 females and six males), with a mean age of 76 years. All the 25 participants were in agreement that the exercises were suitable, (x? = 4.6) and safe (x? = 4.56). 23 participants would also recommend the programme to family and friends? (x? = 4.48). The USE scale is divided into three, sub-domains: cognition (knowledge obtained); emotional (individual's ability to cope with the illness); and behavioural (ability to self-manage). The mean scores for the book on the cognitive, emotional, and behavioural sub-domains were 25.48, 24.08 and 24.04, respectively. Conclusion. Results indicate that the ‘Free From Pain’ exercises are suitable and safe. The book provides educational information that empowers participants to better their musculoskeletal health


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 10 - 10
1 Feb 2020
Haffner N Auersperg V Mercer S Koenigshofer M Rattinger H Ritschl P
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INTRODUCTION. Cementless femoral component designs supplemented with hydroxyapatite (HA) coating have been hypothesised to enhance osseointegration, thereby improving stability and clinical outcomes. We herein offer interim results at 5 years from a prospective, multi-centre study of a femoral stem (SL-PLUS™ Hip Stem Prosthesis), forged from titanium alloy (Ti6Al7Nb) and consisting of a titanium plasma sprayed coating (0.3mm) with an additional 0.05mm layer of HA. METHODS. Investigators at 2 centres enrolled patients between 18–75 years of age who underwent primary total hip arthroplasty (THA) with this HA-coated stem. The study's primary outcome was the clinical efficacy of the stem, as measured by the Harris Hip Score (HHS), Western Ontario & McMaster Universities Osteoarthritis (WOMAC) Score calculated out of Hip Disability and Osteoarthritis Outcome Score (HOOS), and the EuroQol EQ-5D-3L index score and visual analogue scale (VAS). Its secondary outcomes included a radiographic assessment of implant position and fixation, and overall safety, as measured by intraoperative/early postoperative complications and survivorship calculated using Kaplan-Meier estimates. RESULTS. Ninety-three patients (94 hips) were enrolled in the study. At the time of surgery, the study population had a mean age of 60.1 years (standard deviation [SD], 8.4), a mean body mass index of 27.9 kg/m. 2. (SD, 4.75), and 54.8% were female. Indications for surgery include primary osteoarthritis (74.5%), dysplasia (17.5%), femoral head necrosis (6.4%), and other (2.1%). Patients were followed up through 5 years in the ongoing safety and performance analysis. Between preoperative baseline and final follow up, there were notable improvements in the mean scores for all primary clinical outcomes: HHS (51.6 to 91.4, respectively), WOMAC from HOOS (42.6 to 91.0, respectively), mean EQ-5D-3L index score (0.7 to 0.9, respectively), and EQ-5D-3L VAS (54.7 to 80.2, respectively). The majority of patients rated their satisfaction as excellent (84.2% of treated hips), with an additional 14.5% of treated hips being mostly satisfied. Five years after surgery, radiographic findings showed an overall stability of the device, with 100% unchanged stem positions (no movement in varus/valgus or subsidence) and no stem was classified as loose. Intraoperative complications were observed in 3 patients (3.2%), consisting of 2 cases of trochanteric fracture and 1 case of leg lengthening. There were no general early postoperative complications reported in any patient. Two revision surgeries of the study device were reported, both due to infection, resulting in a survivorship of 97.5% (95% confidence interval: 90.3% – 99.4%) at 5 years. CONCLUSION. These results confirm the safety and efficacy of this HA-coated femoral stem at 5 years. All clinical outcomes showed significant improvement between baseline and midterm follow up, with mean HHS in particular meeting the 90-point range considered “excellent.” Additionally, revision rates met the accepted benchmarks for a successful THA device. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_15 | Pages 9 - 9
1 Dec 2021
Ferry T Conrad A Senneville E Roux S Dupieux-Chabert C Dinh A Lustig S Goutelle S Briot T Pham T Valour F
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Aim. Tedizolid is an oxazolidinone antibiotic that: (i) is recommended at the dose of 200 once daily in patients with skin and soft tissue infection; (ii) seems to have a better long-term hematological and neurological safety profile in comparison with linezolid; (iii) remains active on multidrug-resistant (MDR) Gram-positive pathogens. Consequently, it might represent an option as suppressive antimicrobial treatment (SAT) in patients with complex implant-associated bone and joint infection (BJI) due to MDR Gram-positive pathogens. Method. We performed a cohort study (2017–2020) to evaluate the long-term safety of tedizolid (200mg qd) as SAT in patients with implant-associated BJI. In all cases, the use of tedizolid was validated as the last oral treatment option during multidisciplinar meetings in a reference center for the management of BJI. Serious adverse events, any reason for discontinuation, and standard biological data, were prospectively collected. Results. Seventeen patients (13 males; median age 73 years) received tedizolid as SAT for late complex prosthetic-joint infections (n=16) or osteosynthesis (n=1). Pathogens were MDR coagulase negative staphylococci (16 patients), Corynebacterium striatrum (2 patients), Enterococcus faecium (1 patient) and/or S. aureus (1 patient). Tedizolid was always started after a primary treatment (median duration of intravenous 47 days; followed by linezolid in 12 patients including 9 who experienced linezolid-induced serious adverse event) that followed a surgery, mainly debridement and implant retention (13 patients). Median duration of tedizolid was 6 months (min, 1 month; max, 31 months). The only reason for discontinuation was a failure of the conservative strategy that occurred in four patients (17%) during the follow-up. No patients developed a serious adverse event, or a discontinuation of tedizolid due to an adverse event. Anemia was observed in two patients, who had already other known cause of anemia (chronic leukemia and oesophageal varices); stable thrombopenia was observed in a cirrhotic patient (80 G/L, stable during the treatment course of 12 months); and a transient mild neutropenia (1.4 G/L) was observed in another patient (Figure). No neurological adverse event was observed. Conclusions. Tedizolid seems to be a safe option as SAT in patients with complex implantassociated BJI due MDR Gram-positive pathogens. For any tables or figures, please contact the authors directly


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_14 | Pages 79 - 79
1 Mar 2013
Oduah G Ramokgopa M
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Purpose of Study. To investigate the level of Orthopaedic Residents' knowledge of safety techniques in the procedures involving the use of C-arm. Methods. A survey of evidence based questions regarding safety techniques in the use of C-arm was administered to 58 Orthopaedic Residents from three major tertiary hospitals. Results. Of the 58 questionnaires administered, 42 usable questionnaires were returned (a 72.4% response rate). Only 33% of orthopaedic residents have received some form of formal training on safety techniques in the use of a C-arm. 95% of orthopaedic residents protect themselves with a lead apron in every case that that involves the use of a C- arm. 62% of residents do not know that scattered radiation is as harmful as direct radiation. Conclusion. Most orthopaedic residents believe that they are responsible for their own safety, as well as, the safety of their patients and the theatre staff during procedures that involve the use of c-arm. A majority of orthopaedic residents however, lack the detailed knowledge of the safety techniques in the use a C-arm. This knowledge gap may lead to unnecessary exposure to ionising radiation. We therefore, propose a mandatory training on “ionising radiation and safety techniques” for orthopaedic registrars. NO DISCLOSURES


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_14 | Pages 78 - 78
1 Mar 2013
Lisenda L Lukhele M
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Introduction. Surgical complications are common and most of them are preventable. Up to 70 % of surgical errors originate outside theatre and recent studies have shown that pre-op checklists can reduce such problems. We hypothesized that in our institution outcomes could be improved by introducing a safety checklist. Method. A modified multidisciplinary WHO safety checklist was introduced at our institution on the 1st March 2011. The primary focus was for elective patients admitted in all the units of the division. Prior to that all involved personnel (Consultants in Orthopaedics and Anaesthesia, Registrars in both departments, nursing staff in the wards and theatre and clerical staff) were fully oriented. To further ensure that everyone was familiar with the new checklist the whole month of March 2011 was used as a training month. We prospectively collected data from daily Mortality and Morbidity (MM) meetings by units from 1/1/2011 to 29/2/2011 (2 months). A pre-induction survey was completed by all Registrars. The same survey was given to the same registrars for comparison at the end of the 2 month implementation period in June 2011. Results. Only 77% of registrars acknowledged doing pre-op planning prior to implementation of the check list compared to 87.5% post implementation. There was also an increase from 50 to 71% of those who had heard of the surgical check list pre-implementation compared to post implementation. There were 35 cancellations before and 36 after implementation. However if one breaks them into unavoidable and avoidable groups there was 70% reduction of avoidable cancellations (from 10 to 3 patients). There was a 25% reduction of mortality and a 25% reduction of avoidable morbidity. Discussion. In our study there was significant increase in the percentage of registrars who were doing pre-op planning after the implementation of the modified WHO safety check list. The avoidable theatre case cancellations were significantly reduced. It is very hard to attribute the reduction of mortality in our studies to our checklist as the documented causes of death were unavoidable. Compared to published studies our numbers were relatively small but comparable to the SURPASS study which showed reduction of complications from 27.7 % to 16.7 %. The time for getting acquainted to the safety checklist was also very short (1 month) compared to other published studies. Conclusion. The implementation of the modified WHO safety check list was associated with reduction in cancellations, avoidable morbidity and mortality. It should be regarded as a standard practice for all orthopaedic procedures to decrease complications especially in high operation volume and training centres. NO DISCLOSURES


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 49 - 49
1 May 2016
Conditt M Gustke K Coon T Kreuzer S Branch S Bhowmik-Stoker M
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Introduction. Total knee arthroplasty (TKA) using conventional instrumentation has been shown to be a safe and effective way of treating end stage osteoarthritis by restoring function and alleviating pain. As robotic technology is developed to assist surgeons with intra-operative decision making such as joint balancing and component positioning, the safety of these advancements must be established. Furthermore, functional recovery and clinical outcomes should achieve comparable results to the gold standard of conventional instrumentation TKA. Methods. Eighty-seven subjects (89 knees) underwent robotic arm assisted TKA by one of three investigators as part of an FDA and IRB approved Investigational Device Exemption (IDE). To achieve the primary endpoint of intra-operative patient safety using a robotic arm assisted cutting tool, the investigators completed questionnaires to assess a series of complications related to soft tissue damage associated with conventional TKA. Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee Society Knee Scores (KSS) were collected pre-operatively and at three month follow-up. Results. The average subject age was 65.8 ± 8.5 and the average BMI was 31.4 ± 5.7. 55% of the subjects were female. No subject experienced any of the rare intra-operative complications that comprise the primary safety endpoint. The average WOMAC score improvement from pre-operative to three months was 33.1 ± 20.04 (p<0.0001). The average KSS Knee score improvement was 46.1 ± 19.7 (p<0.0001). Subjects recovered their pre-operative range of motion by three months post-operative. Conclusion. Results from this prospective robotic arm assisted trial indicated greater intra-operative safety in blood loss and ligamentous damage when compared to conventional TKA. Subjects had excellent return to function and pain relief by three months as indicated by the KSS and WOMAC scores. Robotic technologies should be considered a safe and effective method in total joint restoration


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_5 | Pages 10 - 10
1 Feb 2016
Tian W Liu Y Fan M Han X
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Background. The Robotic Spinal Surgery System (RSSS) is a robot system designed for pedicle screw insertion containing image based navigation system, trajectory planning system and force state recognition system. The special force state recognition system can guarantee the safety during the operation. The RSSS is helpful in pedicle screw insertion surgery and it will be applied in clinic in the near future. In this study, we evaluated the accuracy and safety of RSSS in an animal experiment. Methods. Computer tomography (CT) scan data for two anesthetised experimental sheep was acquired using the C-arm and transferred to RSSS for pre-surgery screw trajectory planning. With the assist of RSSS, we inserted 8 and 4 screws into two sheep respectively. Operation time and blood loss during the surgery were recorded, and CT scan was repeated after surgery. Real screw position and trajectory acquired by the post-surgery CT scan and ideal trajectory planned by RSSS were compared to evaluate the accuracy and safety of RSSS. The result is shown as mean±SD. Results. We planted totally 12 screws into two sheep. The operation time for each sheep is 140min and 110min, and the blood loss is 100ml and 80 ml respectively. Compared with planned trajectory, the average deviation of the entry points in lateral and axial view are 1.07±0.56mm and 1.25±0.42mm and the mean screw deviation angles in later and axial view are 1.78±0.98°and 2.52±1.03°respectively. The RSSS successfully recognised the force stages and guaranteed the safety during the drilling process. There is no penetration in all 12 pedicles, and all the screws fell into group A according to the Gertzbein-Robbins classification. Conclusion. This animal study demonstrated the accuracy and safety of the RSSS, which also supported the potential application in clinic


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 129 - 129
1 Jan 2016
Park C John T Ghosh G Ranawat AS Ranawat CS
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Introduction. Total hip arthroplasty (THR) with non-cemented or hybrid fixation remains one of the most successful procedures performed today. The aim of this study was to assess the safety and efficacy of a hydroxyapatite (HA) coated, hemispherical cup. Material and Methods. Between 2003 and 2007, 223 THAs (210 patients) with peripheral self-locking (PSL) cup and highly cross-linked polyethylene (Crossfire, Stryker, Mahwah, NJ) with minimum 5 years clinical and radiographic follow-up (5–9 years) were analyzed. The mean age was 62.5 years ± 10.8 (range, 32.7 – 86.3) at the time of surgery and the predominant preoperative diagnoses was osteoarthritis (97.8%). 72% were solid cups without screw augmentation and 28% were multi-hole with screw. Clinical analysis included Hospital for Special Surgery (HSS) hip scores at latest follow-up. Detail radiographic analysis was carried out on anteroposterior and false profile views for evidence of osseointegration in all Charnley's zones. Osseointegration was assessed based on presence of Stress Induced Reactive Cancellous Bone (SIRCaB) with trabecular bone hypertrophy 5–15mm extending from the cup, and absence of radiolucency or demarcation. EBRA software was used to assess cup positioning. Results. At final follow up, clinical result were excellent with average HSS score of 34.8. 4% underwent revision for following reasons: dislocation (1.34%), loose stem (0.89%), stem fracture (0.89%), pain/bursitis (0.45%), and infection (0.45%). There were no revisions for failures of fixation. In radiographic analysis, the average functional cup abduction angle and functional anteversion were 41.7° ± 5.2 (range, 30 – 52) and 16.8° ± 6.1 (range, 4 – 30). 96% of the cups were within the safezone of Lewinnek. There was no progressive radiolucency, migration or change in the cup position at final follow-up. The average overall SIRCaB and radial trabeculae in all 3 zones were 47% and 93%, respectively; both were most prevalent in Zone 1. Conclusion. The hemispherical, peripheral press-fit, HA-coated PSL cup has excellent safety and efficacy, appropriate radiographic osseointegration with no mechanical failures at 5 – 9 years. PSL cup has 1 mm increase in the radius at the periphery of the shell to allow for an enhanced initial press fit. Based on our results, supplementary screw with this cup may not lead to better fixation


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 38 - 38
1 Apr 2019
Meftah M Kirschenbaum I
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Background. There is a recent interest and focus on reducing the length of stay and early discharge after total joint replacement (TJR). However, safety criteria for same-day (SD) or next-day (ND) home discharge are not well defined. We implemented a screening questionnaire to identify patients that qualify for early home discharge. The aim of this study was to assess the efficiency of this questionnaire and short-term outcomes including re-admission and peri-operative complications after TJR. Methods. Between January 2016 and July 2017, 423 consecutive primary hip and knee arthroplasties were performed by the two senior surgeons at our institution. All cases were followed for a minimum of 3-month prospectively after institutional review board approval. Patients were divided based on using a pre-operative questionnaire to determine their disposition after surgery. Group 1 includes 121 cases as control and group 2 includes 302 cases with pre-operative questionnaire. Spinal anesthesia and multimodal pain management including peri-articular injection was used in all cases. The pre-operative questionnaire (PQ, Swiftpath, Inc) included an overall score based on age, comorbidities, body mass index, physical assessment, motivation, comprehension, family support, home setup (i.e. easy access/stairs), proximity to the hospital and lack of serious barriers to early home discharge. Patients were divided into 3 categories based on the score: SD/ND home, regular home discharge and rehabilitation/subacute nursing facility (SNF) discharge. Length of stay (LOS), post-operative complications, readmissions, and discharge destination were assessed. Correlation the questionnaire score and outcomes were assessed. Results. In group 1, 29% of the patients were discharged home after minimum 2 days after surgery with home services and 71% were discharged to short- or long-term rehabilitation center. The mean length of stay was 4.6 ± 2.5 days (range 2 to 7 days). 3% had symptomatic DVT and one patient pulmonary embolism during hospital stay, all after total knee arthroplasty. There was one re-operation for acute periprosthetic infection (0.8%), two cardiopulmonary events (1.6%), and 4 other ER visits for inadequate pain control (3%). In group 2, 51% of the patients were discharged home, 6% of which (10 patients) were same-day discharge. The mean length of stay was 2.2 ± 0.8 days (range 0 to 5 days). One patient (1%) had symptomatic DVT. There were 5 (1.6%) ER visits for wound concerns and pain. There were no acute re-admissions, infections or re-operations. Conclusions. Implementation of a screening questionnaire for SD/ND early discharge is safe and results in significant reduction of length of stay, higher discharge to home, lower rate of DVT/PE/cardiopulmonary complications and less ER visits


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_5 | Pages 7 - 7
1 Apr 2022
Lu W Oomatia A Muderis MA
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Introduction

Osseointegration is a potential treatment option for transfemoral amputees experiencing socket related problems. Till this date, there is little data assessing the feasibility and advantages of osseointegration in individuals with transtibial amputations.

Materials and Methods

We prospectively followed 91 patients undergoing transtibial osseointegration from 2014–2018 who either 1) reported pain or mobility dissatisfaction with socket prosthesis; 2) had an intact limb with incapacitating pain, complex deformity, or profound distal weakness or 3) were recent amputees preferring osseointegration. Adverse events were monitored including infection, periprosthetic fracture, implant breakage, aseptic loosening, revision surgery/additional amputation and death. Functional outcomes were measured using the Questionnaire of persons with a Trans-femoral amputation (Q-TFA) and mobility was assessed using Six Minute Walk Test (6MWT) and Time Up and Go (TUG).


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 19 - 19
1 Dec 2022
Gerges M Messner J Lim B Chhina H Cooper A
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Guided growth is commonly performed by placing an extra-periosteal two-hole plate across the growth plate with one epiphyseal and one metaphyseal screw. Recent work by Keshet et al. (2019) investigated the efficacy of the removal of the metaphyseal screw only (“sleeper plate”) after correction. They concluded the practice to be unnecessary as only 19% of patient show recurrence of deformity. The aim of this study is to examine the incidence of rebound and undesired bony in-growth of the plate (“tethering”) after metaphyseal screw removal only.

In this retrospective case series, patient data on 144 plates inserted around the knee was obtained. Plates still in situ (n=69) at time of study and full hardware removal (n=50) were excluded. The remaining 25 plates had a metaphyseal screw only removed after deformity correction. We analyzed the rate of re-bound, tethering and maintenance of correction in two age groups at latest follow-up for a mean of 3.5 years (1.25 to five). Fisher's exact test with Freeman-Halton extension was used to analyze the two by three contingency table.

Twenty-five plates were identified as “sleeper plates” in our series. 13 plates (52%) maintained the achieved correction after a mean of 21 months (four to 39), nine plates (36%) required screw re-insertion due to rebound after a mean of 22 months (12-48) from screw removal, and four plates (16%) showed tethering with undesired continuation of guided growth after a mean of 14 months (seven to 22) from screw removal. Younger patients (years at time of plate insertion) had higher rates of rebound and tethering (p=.0112, Fisher's exact test). All Tethering occurred in titanium plates, none occurred in steel plates.

The sleeper plate is an acceptable treatment strategy for coronal deformities around the knee. Rebounding and tethering are potential outcomes that occur in younger patients and should be disclosed to patients; titanium plates may increase the risk of tethering, however further long-term follow-up is needed. We stress the importance of close post-operative follow up to identify tethering early and prevent over correction.

The sleeper plate technique is a viable option in younger children with congenital abnormalities, however, continued monitoring of alignment is necessary after screw removal to check for rebound and tethering.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 67 - 67
1 Apr 2018
Xie J Pei F
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Purpose. The hip fracture has been increasing as the aging population continues to grow. Hip fracture patients are more susceptible to blood loss and venous thromboembolism (VTE). The objective of this study was to assess the efficacy and safety of tranexamic acid (TXA) in fracture patients undergoing fast-track hemiarthroplasty. Methods. 609 hip fracture patients undergoing hemiarthropalsty from January 2013 to September 2016 were prospectively selected. 289 patients received 15 mg/kg TXA prior to surgery, and the remaining 320 patients received no TXA. All the patients received a fast-track program including nutrition management, blood management, pain management, VTE prophylaxis and early mobilization and early intake. The primary outcome was transfusion requirement, other parameters such as blood loss, hemoglobin (Hb) level, VTE, adverse events and length of hospital stay were also compared. Multivariate logistic regression analysis and meta-analysis were also performed to identify the risk factors of transfusion and confirm the results of current study. Results. Transfusion of at least 1U of erythrocyte blood cell occurred in 25 patients (8.65%) in treatment group and in 77 (24.06%, OR=0.299, p<0.001) in control group. The mean level of Hb on POD 1 (111.70±18.40 g/L) and POD 3 (108.16±17.25 g/L) in TXA group were higher than control group (107.29±18.70 g/L, p= 0.008; 104.22±15.16 g/L, p= 0.005 respectively). More patients get off bed to ambulate within 24 hours after surgery in TXA group (37.02% Vs 26.25%, p= 0.004). And the length of hospital stay was shorter (11.82±4.39 Vs 15.96±7.30, p= 0.003). No statistical significance were detected regarding VTE and other adverse events. Logistic regression analysis showed that the relative odds reduction after adjustment for these covariates was 67% (OR= 0.327, 95%CIs= 0.197 to 0.544) in favor of tranexamic acid. Other risk factors included preoperative hemoglobin level, operation time, VTE prophylaxis. Pooling the data showed that tranexamic acid led to a significant reduction in transfusion (OR= 0.33, 95%CIs= 0.25 to 0.43) without sacrificing safety (OR= 0.70, 95%CIs= 0.25 to 1.97). Conclusion. Tranexamic acid was effective and safe to reduce blood loss and transfusion in geriatric hip fracture patients undergoing fast-track hemiarthroplasty