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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 11 - 11
1 Jun 2023
Doherty C McKee CM Foster A
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Introduction. Non-union is an unfortunate outcome of the fracture healing process for some patients; with an estimated annual incidence of 17.4- 18.9 per 100,00. The management of these patients depicts a significant clinical challenge for surgeons and financial burden to health services. External ultrasound stimulation devices (Exogen. TM. ) have been highlighted as a novel non invasive therapy to achieve union in cases of delayed and non-union. The aim of the current study was to assess the rate of union in patients using Exogen. TM. therapy for delayed fracture union in a district general hospital. Materials & Methods. This is a single centre retrospective continuous cohort study. Patients were identified from a prospective database of all patients prescribed Exogen. TM. therapy between June 2013- September 2021 in a district general hospital. Patient data was collected retrospectively using electronic patient records. Fracture union was assessed both clinically and radiographically and recorded in patient records. Failure of treatment was defined as progression to operative treatment due to lack of progression with ultrasound therapy or established asymptomatic non-union. Patient were excluded from the study if Exogen. TM. therapy was prescribed within 6 weeks of injury. Results. 142 potential patient were identified from the database. 35 patients were excluded from the data set (17 patients due to insufficient data available, 9 lost to follow up, 4 died and 5 excluded due to early application of Exogen. TM. therapy). 58 Patients progressed to union with an average time to union of 41 weeks. 49 cases failed to progress to union, of which 7 cases had conversion to operative management prior to completion of single course of Exogen. TM. therapy and were excluded from all other data review. 12% of cases that failed to unite with ultrasound therapy required multiple operations to establish union. Conclusions. A union rate of 58% was reported by the current study, which is lower than previously published. This likely reflects the heterogenous nature of the patient population and fracture distribution included. However, this is potentially a more reflective union rate for the general population than previously published. There were no adverse events associated with the use of Exogen. TM. therapy in the current study. Therefore supporting its use as a first line management to promote union in delayed fracture union in the general population. Additionally, failure to achieve fracture union with utilisation of Exogen. TM. therapy was associated with risk for requirement of multiple surgeries to achieve union. This could serve as an indicator for surgeon to consider the requirement additional measures at the initial surgical procedure


Bone & Joint 360
Vol. 10, Issue 3 | Pages 13 - 16
1 Jun 2021


The Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 494 - 502
1 Apr 2017
Simpson AHRW Keenan G Nayagam S Atkins RM Marsh D Clement ND

Aims

The aim of this double-blind prospective randomised controlled trial was to assess whether low intensity pulsed ultrasound (LIPUS) accelerated or enhanced the rate of bone healing in adult patients undergoing distraction osteogenesis.

Patients and Methods

A total of 62 adult patients undergoing limb lengthening or bone transport by distraction osteogenesis were randomised to treatment with either an active (n = 32) or a placebo (n = 30) ultrasound device. A standardised corticotomy was performed in the proximal tibial metaphysis and a circular Ilizarov frame was used in all patients. The rate of distraction was also standardised. The primary outcome measure was the time to removal of the frame after adjusting for the length of distraction in days/cm for both the per protocol (PP) and the intention-to-treat (ITT) groups. The assessor was blinded to the form of treatment. A secondary outcome was to identify covariates affecting the time to removal of the frame.


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1226 - 1231
1 Sep 2015
Nakamura R Komatsu N Murao T Okamoto Y Nakamura S Fujita K Nishimura H Katsuki Y

The objective of this study was to validate the efficacy of Takeuchi classification for lateral hinge fractures (LHFs) in open wedge high tibial osteotomy (OWHTO). In all 74 osteoarthritic knees (58 females, 16 males; mean age 62.9 years, standard deviation 7.5, 42 to 77) were treated with OWHTO using a TomoFix plate. The knees were divided into non-fracture (59 knees) and LHF (15 knees) groups, and the LHF group was further divided into Takeuchi types I, II, and III (seven, two, and six knees, respectively). The outcomes were assessed pre-operatively and one year after OWHTO. Pre-operative characteristics (age, gender and body mass index) showed no significant difference between the two groups. The mean Japanese Orthopaedic Association score was significantly improved one year after operation regardless of the presence or absence of LHF (p = 0.0015, p < 0.001, respectively). However, six of seven type I cases had no LHF-related complications; both type II cases had delayed union; and of six type III cases, two had delayed union with correction loss and one had overcorrection. These results suggest that Takeuchi type II and III LHFs are structurally unstable compared with type I.

Cite this article: Bone Joint J 2015;97-B:1226–31.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_5 | Pages 13 - 13
1 May 2015
Mitchell C Timms A Laubscher M Goodier D Calder P
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Background:. The Exogen Ultrasound Device is licensed for fracture non-union under NICE guideline MTG-12. Reimbursement is offered if there is no fracture union after 250 days of treatment as per manufacturer guidelines. Quoted healing rates vary between 62% and 100%: we compare our results to these. Method:. A retrospective audit of all patients who received Exogen for long bone non-union was undertaken. The indication, duration of treatment, fracture outcome and compliance with the recommended treatment pathway were recorded. Results:. 41 patients (17M 24F) mean age 41yr were reviewed. There were 15 femoral, 22 tibial and 4 humeral non unions. 16 healed following a mean of 169 days of Exogen treatment (39%). 21 patients did not show any improvement in radiological/clinical union and required further surgery. 4 were not united after 250 days of Exogen treatment. No reimbursements were received. Discussion:. Our results with Exogen differ from published studies with lower than expected healing rates. Failure to complete the recommended pathway however resulted in a breach of the reimbursement stipulations. Conclusion:. Ongoing review of prescription and use of the Exogen device is required to ensure optimum patient outcomes. 250 days of treatment may not be required to determine failure to heal


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_6 | Pages 3 - 3
1 May 2015
Angel C Taylor C Easwaran P Butler M Norton M
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This study reviewed all patients who received an EXOGEN Express bone stimulating device (BSD) to treat delayed union / non-union following operative treatment for a long bone fracture & evaluate if our results are comparable with the NICE guideline expectations. A retrospective review of records between December 2004 & January 2013 revealed 113 patients treated with a BSD. A total of 59 patients were eligible for analysis, (operative treatment for a long bone fracture with adjuvant EXOGEN BSD for non-union or delayed union). Twenty-one were open fractures. The BSD was applied at a mean of 264 days post-operatively. Thirty-five patients went on to have a 2nd operation before union was achieved. Forty-two patients went on to union following application of the BSD. Mean time to union was 293 days. Seventeen patients failed to unite by the end of the study. There were no adverse reactions to the EXOGEN BSD in this cohort. This study has shown that the use of an EXOGEN BSD is a safe, non-invasive method to successfully treat long bone non-unions following initial operative surgery, with potential cost savings (a potential saving of £48,888 to the hospital according to NICE estimations) compared to the standard re-operative management


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_10 | Pages 12 - 12
1 Jul 2014
Fenton P Hughes A Howard D Atkins R Jackson M Mitchell S Livingstone J
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Percutaneous grafting of non-union using bone marrow concentrates has shown promising results, we present our experience and outcomes following the use of microdrilling and marrowstim in long bone non-unions. We retrospectively reviewed all patients undergoing a marrowstim procedure for non-union in 2011–12. Casenotes and radiographs were reviewed for all. Details of injury, previous surgery and non-union interventions together with additional procedures performed after marrowstim were recorded for all patients. The time to clinical and radiological union were noted. We identified 32 patients, in sixteen the tibia was involved in 15 the femur and in one the humerus. Ten of the 32 had undergone intervention for non-union prior to marrowstim including 4 exchange nailings, 2 nail dynamisations, 3 caption graftings, 2 compression in circular frame and 1 revision of internal fixation. Three underwent adjunctive procedures at the time of marroswstim. In 18 further procedures were required following marrowstim. In 4 this involved frame adjustment, 5 underwent exchange nailing, 4 revision internal fixation, 2 additional marrowstim, 2 autologous bone grafting and 3 a course of exogen treatment. In total 27 achieved radiological and clinical union at a mean of 9.6 months, of these ten achieved union without requiring additional intervention following marrowstim, at a mean of 5.4 months. There were no complications relating to marrowstim harvest or application. Marrowstim appears to be a safe and relatively cheap addition to the armamentarium for treatment of non-union. However many patients require further procedures in addition to marrowstim to achieve union. Furthermore given the range of procedures this cohort of patients have undergone before and after marrowstim intervention it is difficult to draw conclusions regarding it efficacy


The Bone & Joint Journal
Vol. 95-B, Issue 12 | Pages 1687 - 1696
1 Dec 2013
Nishizuka T Tatebe M Hirata H Shinohara T Yamamoto M Iwatsuki K

The purpose of this study was to evaluate treatment results following arthroscopic triangular fibrocartilage complex (TFCC) debridement for recalcitrant ulnar wrist pain. According to the treatment algorithm, 66 patients (36 men and 30 women with a mean age of 38.1 years (15 to 67)) with recalcitrant ulnar wrist pain were allocated to undergo ulnar shortening osteotomy (USO; n = 24), arthroscopic TFCC repair (n = 15), arthroscopic TFCC debridement (n = 14) or prolonged conservative treatment (n = 13). The mean follow-up was 36.0 months (15 to 54). Significant differences in Hand20 score at 18 months were evident between the USO group and TFCC debridement group (p = 0.003), and between the TFCC repair group and TFCC debridement group (p = 0.029). Within-group comparisons showed that Hand20 score at five months or later and pain score at two months or later were significantly decreased in the USO/TFCC repair groups. In contrast, scores in the TFCC debridement/conservative groups did not decrease significantly. Grip strength at 18 months was significantly improved in the USO/TFCC repair groups, but not in the TFCC debridement/conservative groups. TFCC debridement shows little benefit on the clinical course of recalcitrant ulnar wrist pain even after excluding patients with ulnocarpal abutment or TFCC detachment from the fovea from the indications for arthroscopic TFCC debridement.

Cite this article: Bone Joint J 2013;95-B:1687–96.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_3 | Pages 6 - 6
1 Jan 2013
Sarmah S Fenton C Raman R Gopal S Roy N Sharma H
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Purpose of study. The aim of this study is to evaluate the role of low intensity pulsed ultrasound, Exogen in the treatment of delayed and non unions. Methodology: We conducted a retrospective study of 292 patients who has had Exogen treatment for delayed and non union from 2005 to 2009. Patient's age, sex, associated co morbidities, smoking history, medications, type of fractures (open/closed), infection and site of fractures were sought for. 271 patients' data (228 delayed and 43 non unions) were available during the study with mean age of 53.5 yrs. Exogen therapy was initiated at 3–4 months for delayed unions and 6–12 months for non unions in 61 tibia (15 open); 31 femur (2 open); 20 scaphoid; 38 5th metatarsal; 31 ankle (2 open); 17 ulna (1 open); 15 radius (3 open); 29 humerus (2 open); 16 clavicles; 6 olecranon; 4 pilon (2 open) and 2 metacarpal fractures. Discussion. Union was achieved in 196 patients (72.3%) of which 11 (5.6%) were smokers. In 73 (26.9 %) patients union was not achieved of which 53 (72 %) were smokers. The mean healing timing after application of Exogen was 16 weeks for delayed union and 26.6 weeks for non union. 5 (31.2%) pt out of 16 in the DM group went into non union. Conclusion. In our study we found an accelerated union rate with Exogen therapy in delayed union, however smoking is a negative predictor for bone healing, which appears to be unaltered despite Exogen therapy(p=0.0032). Prescribing Exogen therapy early may be potentially beneficial to prevent an established non union


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 70 - 70
1 Mar 2010
Lienau J Schell H Schmidt-Bleek K Perka C Bail H Duda G
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*Winner of ISFR Young Investigator Award. Purpose: The aim of this study was to compare the temporal expression pattern of factors related to cartilage and bone formation and endochondral ossification during standard and delayed bone healing for a more in-depth understanding of the molecular basis of disturbed bone healing and to elucidate suitable timing for substitution of factors to stimulate the healing process. Methods: A tibial osteotomy was performed in two groups of sheep (n=30 each) and stabilized with either a rigid external fixator leading to standard healing or with a mechanically critical one leading to delayed healing. Hematoma/callus tissue was harvested 4, 7, 14, 21 and 42 days postop. qPCR was employed to determine the expression patterns of BMPs and other molecules. Results: Gene expressions of BMP2, BMP4, BMP7, Noggin, MMP9 and MMP13 were distinctly lower in the delayed compared to the standard healing group at several time points from day 14, whilst no differential gene expression of Coll II and Coll X was found between both groups. Among the BMPs, BMP7 showed the most markedly differential expression. The first evident difference in BMP7 expression between both groups was found at day 14 suggesting that exogen substitution in the context of a therapeutic approach should be postponed. The differential expression pattern of both MMP9 and MMP13 suggests that there might be a failure or delay in endochondral ossification in delayed bone healing. Conclusion: Downregulation in gene expression of osteogenic BMPs and cartilage matrix degrading MMPs may account for a considerable delay of bone healing


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 447 - 447
1 Sep 2009
Legenstein R Huber W Ungersboeck A Gottsauner-Wolf F Boesch P
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The development of metalosis is a not commonly reported complication after THR. The exact reasons are still unknown, but hypersensitivity reaction is favored ahead of toxic effects, immune defects and exogen causes. The phenomenon of metalosis occurred at an unpredictable time in situ and is often misinterpreted as a low grade infection. In a retrospective study, we analysed all 173 (102 women and 71 men) primary and single cement less PPF THR (STRATEC®) with metal-on-metal (low carbide 0.08%) articulation of 1995. One patient was lost to follow-up, 18 patients were deceased. The average age at the time of surgery was 63.3 years and the follow-up time was 115 months. 40 (23.1%) metalosis cases were observed. Revision was done in 29 (16.8%) patients: three femur fractures, five cases of infection and 21 cases of metalosis. The median HHS at follow-up was 95. 18 cases (10.4%) had metalosis signs: six patients (3.2%) had periprosthetic osteolysis and pain, 16 patients (9.2%) had osteolysis without pain and nine patients (5.2%) had pain without osteolysis in the radiographs. Pain caused by metalosis typically occurred inguinal and at an average time of thirty months postoperatively. Dislocation was observed in 13 cases at an average time of 44 months with an average cup inclination of 48°. Extensive necrosis and diffuse lymphoplasmacytic infiltrates were noted. In most cases the bursa ileopectinea was highly filled and in this synovial fluid extremely elevated levels of chrome (32 – 46095 μg/l) and cobalt (30 – 67410 μg/l) were detected. Since 2003, we do not implant or recommend metal-on-metal for THR anymore. Close radiographic and computertomographic monitoring with high mark on typical osteolysis and exact clinical evaluation is recommended for metal-on-metal THR. Patients without symptoms with severe osteolysis must be detected, and head and inlay changes must be performed


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 7 | Pages 889 - 895
1 Jul 2005
Deehan DJ Cawston TE


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 267 - 267
1 Mar 2003
Uglo M Hile M Briody J Bilston L Little D
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Low intensity pulsed ultrasound (SAFHS, Exogen Inc.) was used to treat 15 immature New Zealand white rabbits following a mid diaphyseal tibial osteotomy and 1cm bone lengthening using an Orthofix M-100 device. Fifteen matched controls underwent an identical procedure but the ultrasound transducer was not switched on. At 4 and 6 weeks postoperatively the tibiae were analysed using DXA, QCT and 4 point bend mechanical testing. There were no differences identified between the active and control groups at 4 or 6 weeks with respect to bone mineral content or cross-sectional area of the regenerate, nor the bone proximal and distal to it. No improvement in strength of the regenerate was identified in either group. We cannot, therefore, support the use of the SAFHS to accelerate bone healing in patients undergoing limb lengthening. Low intensity pulsed ultrasound has been shown to accelerate fracture healing in animals and humans. The mechanisms of action are discussed and we propose that the intensity of the ultrasound may need to be increased mechanically to stimulate a bone that is rigidly fixed using the M-100 fixator