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The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 82 - 87
1 Jan 2023
Barrie A Kent B

Aims. Management of displaced paediatric supracondylar elbow fractures remains widely debated and actual practice is unclear. This national trainee collaboration aimed to evaluate surgical and postoperative management of these injuries across the UK. Methods. This study was led by the South West Orthopaedic Research Division (SWORD) and performed by the Supra Man Collaborative. Displaced paediatric supracondylar elbow fractures undergoing surgery between 1 January 2019 and 31 December 2019 were retrospectively identified and their anonymized data were collected via Research Electronic Data Capture (REDCap). Results. A total of 972 patients were identified across 41 hospitals. Mean age at injury was 6.3 years (1 to 15), 504 were male (52%), 583 involved the left side (60%), and 538 were Gartland type 3 fractures (55%). Median time from injury to theatre was 16 hours (interquartile range (IQR) 6.6 to 22), 300 patients (31%) underwent surgery on the day of injury, and 91 (9%) underwent surgery between 10:00 pm and 8:00 am. Overall, 910 patients (94%) had Kirschner (K)-wire) fixation and these were left percutaneous in 869 (95%), while 62 patients (6%) had manipulation under anaesthetic (MUA) and casting. Crossed K-wire configuration was used as fixation in 544 cases (59.5%). Overall, 208 of the fixation cases (61%) performed or supervised by a paediatric orthopaedic consultant underwent lateral-only fixation, whereas 153 (27%) of the fixation cases performed or supervised by a non-paediatric orthopaedic consultant used lateral-only fixation. In total, 129 percutaneous wires (16%) were removed in theatre. Of the 341 percutaneous wire fixations performed or supervised by a paediatric orthopaedic consultant, 11 (3%) underwent wire removal in theatre, whereas 118 (22%) of the 528 percutaneous wire fixation cases performed or supervised by a non-paediatric orthopaedic consultant underwent wire removal in theatre. Four MUA patients (6%) and seven K-wire fixation patients (0.8%) required revision surgery within 30 days for displacement. Conclusion. The treatment of supracondylar elbow fractures in children varies across the UK. Patient cases where a paediatric orthopaedic consultant was involved had an increased tendency for lateral only K-wire fixation and for wire removal in clinic. Low rates of displacement requiring revision surgery were identified in all fixation configurations. Cite this article: Bone Joint J 2023;105-B(1):82–87


The Bone & Joint Journal
Vol. 100-B, Issue 3 | Pages 387 - 395
1 Mar 2018
Ganeshalingam R Donnan A Evans O Hoq M Camp M Donnan L

Aims. Displaced fractures of the lateral condyle of the humerus are frequently managed surgically with the aim of avoiding nonunion, malunion, disturbances of growth and later arthritis. The ideal method of fixation is however not known, and treatment varies between surgeons and hospitals. The aim of this study was to compare the outcome of two well-established forms of surgical treatment, Kirschner wire (K-wire) and screw fixation. Patients and Methods. A retrospective cohort study of children who underwent surgical treatment for a fracture of the lateral condyle of the humerus between January 2005 and December 2014 at two centres was undertaken. Pre, intraoperative and postoperative characteristics were evaluated. A total of 336 children were included in the study. Their mean age at the time of injury was 5.8 years (0 to 15) with a male:female patient ratio of 3:2. A total of 243 (72%) had a Milch II fracture and the fracture was displaced by > 2 mm in 228 (68%). In all, 235 patients underwent K-wire fixation and 101 had screw fixation. . Results. There was a higher rate of nonunion with K-wire fixation (p = 0.02). There was no difference in Baumann’s angle, carrying angle or the rate of major complications between the two groups. No benefit was obtained by immobilizing the elbow for more than four weeks in either group. No short-term complications were seen when fixation crossed the lateral ossific nucleus. Conclusions. Fixation of lateral condylar humeral fractures in children using either K-wires or screws gives satisfactory results. Proponents of both techniques may find justification of their methods in our data, but prospective, randomized trials with long-term follow-up are required to confirm the findings, which suggest a higher rate of nonunion with K-wire fixation. Cite this article: Bone Joint J 2018;100-B:387–95


The Bone & Joint Journal
Vol. 101-B, Issue 9 | Pages 1160 - 1167
1 Sep 2019
Wang WT Li YQ Guo YM Li M Mei HB Shao JF Xiong Z Li J Canavese F Chen SY

Aims. The aim of this study was to clarify the factors that predict the development of avascular necrosis (AVN) of the femoral head in children with a fracture of the femoral neck. Patients and Methods. We retrospectively reviewed 239 children with a mean age of 10.0 years (. sd. 3.9) who underwent surgical treatment for a femoral neck fracture. Risk factors were recorded, including age, sex, laterality, mechanism of injury, initial displacement, the type of fracture, the time to reduction, and the method and quality of reduction. AVN of the femoral head was assessed on radiographs. Logistic regression analysis was used to evaluate the independent risk factors for AVN. Chi-squared tests and Student’s t-tests were used for subgroup analyses to determine the risk factors for AVN. Results. We found that age (p = 0.006) and initial displacement (p = 0.001) were significant independent risk factors. Receiver operating characteristic (ROC) curve analysis indicated that 12 years of age was the cut-off for increasing the rate of AVN. Severe initial displacement (p = 0.021) and poor quality of reduction (p = 0.022) significantly increased the rate of AVN in patients aged 12 years or greater, while in those aged less than 12 years, the rate of AVN significantly increased only with initial displacement (p = 0.048). A poor reduction significantly increased the rate of AVN in patients treated by closed reduction (p = 0.026); screw and plate fixation was preferable to cannulated screw or Kirschner wire (K-wire) fixation for decreasing the rate of AVN in patients treated by open reduction (p = 0.034). Conclusion. The rate of AVN increases with age, especially in patients aged 12 years or greater, and with the severity of displacement. In patients treated by closed reduction, anatomical reduction helps to decrease the rate of AVN, while in those treated by open reduction, screw and plate fixation was preferable to fixation using cannulated screws or K-wires. Cite this article: Bone Joint J 2019;101-B:1160–1167


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 3 | Pages 413 - 417
1 Apr 2002
McLauchlan GJ Cowan B Annan IH Robb JE

In a prospective, randomised controlled trial, 68 children who had a completely displaced metaphyseal fracture of the distal radius were treated either by manipulation (MUA) and application of an above-elbow cast alone or by the additional insertion of a percutaneous Kirschner (K-) wire. Full radiological follow-up to union was obtained in 65 children and 56 returned for clinical evaluation three months after injury. Maintenance of reduction was significantly better in the K-wire group and fewer follow-up radiographs were required. There was no significant difference in the clinical outcome measured three months after injury. Seven of 33 patients in the MUA group had to undergo a second procedure because of an unacceptable position compared with none of the 35 in the K-wire group (chi-squared test, p < 0.01). One patient in the K-wire group required exploration for recovery of a migrated wire. We conclude that the use of a percutaneous K-wire to augment the reduction of the fracture in children who have a completely displaced metaphyseal fracture of the distal radius is a safe and reliable way of maintaining alignment of the fracture


Bone & Joint Open
Vol. 5, Issue 7 | Pages 581 - 591
12 Jul 2024
Wang W Xiong Z Huang D Li Y Huang Y Guo Y Andreacchio A Canavese F Chen S

Aims

To investigate the risk factors for unsuccessful radial head reduction (RHR) in children with chronic Monteggia fractures (CMFs) treated surgically.

Methods

A total of 209 children (mean age 6.84 years (SD 2.87)), who underwent surgical treatment for CMFs between March 2015 and March 2023 at six institutions, were retrospectively reviewed. Assessed risk factors included age, sex, laterality, dislocation direction and distance, preoperative proximal radial metaphysis width, time from injury to surgery, reduction method, annular ligament reconstruction, radiocapitellar joint fixation, ulnar osteotomy, site of ulnar osteotomy, preoperative and postoperative ulnar angulation, ulnar fixation method, progressive ulnar distraction, and postoperative cast immobilization. Independent-samples t-test, chi-squared test, and logistic regression analysis were used to identify the risk factors associated with unsuccessful RHR.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 331 - 340
1 Mar 2023
Vogt B Toporowski G Gosheger G Laufer A Frommer A Kleine-Koenig M Roedl R Antfang C

Aims

Temporary hemiepiphysiodesis (HED) is applied to children and adolescents to correct angular deformities (ADs) in long bones through guided growth. Traditional Blount staples or two-hole plates are mainly used for this indication. Despite precise surgical techniques and attentive postoperative follow-up, implant-associated complications are frequently described. To address these pitfalls, a flexible staple was developed to combine the advantages of the established implants. This study provides the first results of guided growth using the new implant and compares these with the established two-hole plates and Blount staples.

Methods

Between January 2013 and December 2016, 138 patients (22 children, 116 adolescents) with genu valgum or genu varum were treated with 285 flexible staples. The minimum follow-up was 24 months. These results were compared with 98 patients treated with 205 two-hole plates and 92 patients treated with 535 Blount staples. In long-standing anteroposterior radiographs, mechanical axis deviations (MADs) were measured before and during treatment to analyze treatment efficiency. The evaluation of the new flexible staple was performed according to the idea, development, evaluation, assessment, long-term (IDEAL) study framework (Stage 2a).


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 212 - 218
1 Feb 2024
Liu S Su Y

Aims

Medial humeral epicondyle fractures (MHEFs) are common elbow fractures in children. Open reduction should be performed in patients with MHEF who have entrapped intra-articular fragments as well as displacement. However, following open reduction, transposition of the ulnar nerve is disputed. The aim of this study is to evaluate the need for ulnar nerve exploration and transposition.

Methods

This was a retrospective cohort study. The clinical data of patients who underwent surgical treatment of MHEF in our hospital from January 2015 to January 2022 were collected. The patients were allocated to either transposition or non-transposition groups. Data for sex, age, cause of fracture, duration of follow-up, Papavasiliou and Crawford classification, injury-to-surgery time, preoperative ulnar nerve symptoms, intraoperative exploration of ulnar nerve injury, surgical incision length, intraoperative blood loss, postoperative ulnar nerve symptoms, complications, persistent ulnar neuropathy, and elbow joint function were analyzed. Binary logistic regression analysis was used for statistical analysis.


The Bone & Joint Journal
Vol. 98-B, Issue 1 | Pages 131 - 136
1 Jan 2016
Kurien T Price KR Pearson RG Dieppe C Hunter JB

A retrospective study was performed in 100 children aged between two and 16 years, with a dorsally angulated stable fracture of the distal radius or forearm, who were treated with manipulation in the emergency department (ED) using intranasal diamorphine and 50% oxygen and nitrous oxide. Pre- and post-manipulation radiographs, the final radiographs and the clinical notes were reviewed. A successful reduction was achieved in 90 fractures (90%) and only three children (3%) required remanipulation and Kirschner wire fixation or internal fixation. The use of Entonox and intranasal diamorphine is safe and effective for the closed reduction of a stable paediatric fracture of the distal radius and forearm in the ED. . By facilitating discharge on the same day, there is a substantial cost benefit to families and the NHS and we recommend this method. Take home message: Simple easily reducible fractures of the distal radius and forearm in children can be successfully and safely treated in the ED using this approach, thus avoiding theatre admission and costly hospital stay. . Cite this article: Bone Joint J 2016;97-B:131–6


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_VI | Pages 12 - 12
1 Mar 2012
Akula M Madhu T Scott B Templeton P
Full Access

Purpose of the study. We describe a new technique of talar dome osteotomy in the treatment of fixed equinovalgus deformity of the foot in patients with Fibular Hemimelia and successfully applied it in two patients. Background. Fibular Hemimelia is a congenital absence or hypoplasia of fibula with associated fixed equinovalgus deformity of the foot. Treatment for this deformity ranges from corrective osteotomy of the tibia, calcaneum to Syme's amputation. Methods. The procedure of talar dome osteotomy is best applied to children before they start to walk. Through a Cincinnati approach, fibular anlage was excised and a talar dome osteotomy performed in the axial plane to correct the valgus deformity of the ankle. Additional procedures if required include corrective osteotomy of the distal tibia to correct remaining foot deformity after the initial correction, and tendo achillis lengthening. The corrected position is then maintained with a K-wire inserted through the calcaneum, osteotamised talus up into the distal tibia. K-wire was removed at 6 weeks and foot position thereafter maintained in an AFO orthrosis with the foot slightly inverted for next 2 years. Two patients diagnosed with fibular hemimelia (Coventry and Johnson type II) underwent correction of their fixed equino-valgus deformity with the above mentioned technique at the ages of 6 and 10 months respectively. AFO orthosis was used for two years and at 5 years of follow-up the deformity has remained corrected in both the ankles. Both these patients are due to undergo limb-lengthening procedures


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 9 | Pages 1259 - 1263
1 Sep 2005
Steinlechner CWB Mkandawire NC

The management of chronic osteomyelitis requires the excision of necrotic and infected material followed by the prolonged administration of antibiotics. Sequestrectomy may be required before an involucrum has formed, resulting in a longitudinal bone defect. This can be difficult to fill. Vascularised grafts are complicated by a high rate of recurrent infection and thrombosis. We have managed defects of long bones in children after sequestrectomy by the use of non-vascularised fibular grafts harvested subperiosteally and held by an intramedullary Kirschner wire. Eight children underwent this procedure. In six the tibia was involved and in one each the humerus and radius. One patient was lost to follow-up. Six grafts united at both ends within 12 weeks. The seventh developed an infected nonunion distally which united after further debridement. One patient required a further sequestrectomy which did not compromise union. We have found this to be a straightforward technique with reliable results and were able to salvage the limb in all the seven patients who were reviewed


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1428 - 1437
2 Aug 2021
Vogt B Roedl R Gosheger G Frommer A Laufer A Kleine-Koenig M Theil C Toporowski G

Aims

Temporary epiphysiodesis (ED) is commonly applied in children and adolescents to treat leg length discrepancies (LLDs) and tall stature. Traditional Blount staples or modern two-hole plates are used in clinical practice. However, they require accurate planning, precise surgical techniques, and attentive follow-up to achieve the desired outcome without complications. This study reports the results of ED using a novel rigid staple (RigidTack) incorporating safety, as well as technical and procedural success according to the idea, development, evaluation, assessment, long-term (IDEAL) study framework.

Methods

A cohort of 56 patients, including 45 unilateral EDs for LLD and 11 bilateral EDs for tall stature, were prospectively analyzed. ED was performed with 222 rigid staples with a mean follow-up of 24.4 months (8 to 49). Patients with a predicted LLD of ≥ 2 cm at skeletal maturity were included. Mean age at surgery was 12.1 years (8 to 14). Correction and complication rates including implant-associated problems, and secondary deformities as well as perioperative parameters, were recorded (IDEAL stage 2a). These results were compared to historical cohorts treated for correction of LLD with two-hole plates or Blount staples.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 86 - 92
10 Feb 2021
Ibrahim Y Huq S Shanmuganathan K Gille H Buddhdev P

Aims

This observational study examines the effect of the COVID-19 pandemic upon the paediatric trauma burden of a district general hospital. We aim to compare the nature and volume of the paediatric trauma during the first 2020 UK lockdown period with the same period in 2019.

Methods

Prospective data was collected from 23 March 2020 to 14 June 2020 and compared with retrospective data collected from 23 March 2019 to 14 June 2019. Patient demographics, mechanism of injury, nature of the injury, and details of any surgery were tabulated and statistically analyzed using the independent-samples t-test for normally distributed data and the Mann-Whitney-U test for non-parametric data. Additionally, patients were contacted by telephone to further explore the mechanism of injury where required, to gain some qualitative insight into the risk factors for injury.


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1248 - 1255
1 Sep 2020
Laufer A Frommer A Gosheger G Roedl R Broeking JN Toporowski G Rachbauer AM Vogt B

Aims

The treatment of tibial aplasia is controversial. Amputation represents the gold standard with good functional results, but is frequently refused by the families. In these patients, treatment with reconstructive limb salvage can be considered. Due to the complexity of the deformity, this remains challenging and should be staged. The present study evaluated the role of femoro-pedal distraction using a circular external fixator in reconstructive treatment of tibial aplasia. The purpose of femoro-pedal distraction is to realign the limb and achieve soft tissue lengthening to allow subsequent reconstructive surgery.

Methods

This was a retrospective study involving ten patients (12 limbs) with tibial aplasia, who underwent staged reconstruction. During the first operation a circular hexapod external fixator was applied and femoro-pedal distraction was undertaken over several months. Subsequent surgery included reconstruction of the knee joint and alignment of the foot.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_11 | Pages 1 - 1
1 Feb 2013
Sanghrajka A Jones S Flowers M
Full Access

Aim. Differing reports about the surgical management of the supracondylar humeral fracture make evidence-based practice very difficult, so knowledge of the contemporary practices and opinions of an expert body can provide a useful benchmark for appraisal; the aim of this study was to obtain this information. Methods. An electronic 18 item, single response multiple-choice questionnaire was designed to investigate various aspects of the surgical management of supracondylar fractures, with particular focus on areas that remain controversial in the literature. Members of BSCOS were invited by email, on three occasions, to complete the questionnaire, which was posted on the web-based SurveyMonkey™ platform (. www.surveymonkey.com. , California, USA). The survey was available for completion for a period of 10 weeks. Results. 102 responses were received (response rate 56.7%); all respondents completed the entire questionnaire. There was almost complete agreement (>90%) in only three areas: -The preferred management of Gartland 3 fractures; The management of the fracture with an absent radial pulse and impaired digital perfusion; An ulnar nerve palsy detected four weeks post-operatively. Majority agreement (>60%) was found regarding: - Possible consequences of delay in performing closed reduction; Management of the pink, perfused hand with an absent radial pulse; Necessity of anatomical reduction. There was no consensus regarding: - K-wiring of Gartland 2 fractures; Management of ulnar nerve palsy detected one week post-operatively; Open insertion of the medial K-wire. Conclusion. Reflecting current trends and attitudes, this survey provides information against which an individual surgeon can appraise their own practice. Strong consensus existed in areas in which clear evidence is available to inform practice. This highlights the importance of good-quality research, and identifies areas requiring further investigation


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 755 - 765
1 Jun 2020
Liebs TR Burgard M Kaiser N Slongo T Berger S Ryser B Ziebarth K

Aims

We aimed to evaluate the health-related quality of life (HRQoL) in children with supracondylar humeral fractures (SCHFs), who were treated following the recommendations of the Paediatric Comprehensive AO Classification, and to assess if HRQoL was associated with AO fracture classification, or fixation with a lateral external fixator compared with closed reduction and percutaneous pinning (CRPP).

Methods

We were able to follow-up on 775 patients (395 girls, 380 boys) who sustained a SCHF from 2004 to 2017. Patients completed questionnaires including the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH; primary outcome), and the Pediatric Quality of Life Inventory (PedsQL).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_11 | Pages 4 - 4
1 Feb 2013
Carsi B Kent M Wright E Gent E
Full Access

Aim. We evaluated the outcome of conservative versus surgical treatment in lateral humeral condyle fractures in children. The management in some of these fractures remains controversial, ultimately relying upon the individual practitioner. Methods. We identified 73 children who sustained such fractures, with varying degrees of displacement, during the period between April 2006 and October 2011. Results. There were 41 boys and 32 girls. The mean age at the time of injury was 5.2 years (range 0.84–11.92). According to Milch's classification, there were 4 type I and 69 type II fractures. Undisplaced fractures (Jakob grade I, n= 30) were almost universally treated conservatively (n=29) whilst all severely displaced fractures (Jakob grade III, n= 15) were treated surgically, by closed or open reduction and k-wires or screws. However, the protocol differed for those fractures displaced 2–3 mm (Jakob grade II) and was mainly based on surgeon's preferences and clinical examination. Fifteen of 28 (53.57%) were initially treated in plaster whilst 13 (46.43%) were operated upon. Two of the former (2/18 or 11.11%), plus one minimally displaced (1/30 or 3.33%), required subsequent surgical fixation. One of the k-wire fixations was revised into a compression screw due to the fracture not uniting after 4 weeks. Other complications after treatment included fourteen mal-unions (2 after conservative and 12 after surgical treatment). There was no avascular necrosis or deep infection in this series. Conclusion. Although surgical treatment has been advocated as the gold standard for all displaced fractures, some initially displaced fractures may be stable and go on to heal in plaster with an acceptably low conversion rate. However, this requires close follow-up and careful examination to indicate surgical treatment if healing does not occur, or there is further fracture displacement


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1412 - 1418
3 Oct 2020
Ballhause TM Stiel N Breyer S Stücker R Spiro AS

Aims

Eight-plates are used to correct varus-valgus deformity (VVD) or limb-length discrepancy (LLD) in children and adolescents. It was reported that these implants might create a bony deformity within the knee joint by change of the roof angle (RA) after epiphysiodesis of the proximal tibia following a radiological assessment limited to anteroposterior (AP) radiographs. The aim of this study was to analyze the RA, complemented with lateral knee radiographs, with focus on the tibial slope (TS) and the degree of deformity correction.

Methods

A retrospective, single-centre study was conducted. The treatment group (n = 64 knees in 44 patients) was subclassified according to the implant location in two groups: 1) medial hemiepiphysiodesis; and 2) lateral hemiepiphysiodesis. A third control group consisted of 25 untreated knees. The limb axes and RA were measured on long standing AP leg radiographs. Lateral radiographs of 40 knees were available for TS analysis. The mean age of the patients was 10.6 years (4 to 15) in the treatment group and 8.4 years (4 to 14) in the control group. Implants were removed after a mean 1.2 years (0.5 to 3).


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 4 | Pages 536 - 541
1 May 2001
Stiefel D Meuli M Altermatt S

The treatment of fractures of the neck of the radius in children is difficult, particularly if the angulation of the fracture exceeds 60°. Since 1994 we have used closed reduction and stabilisation with an intramedullary Kirschner wire in patients with grade-IV fractures according to the classification of Judet et al. In a retrospective analysis of a two-year period (1994 to 1996), 324 children with fractures of the elbow were treated in our department. Of these, 29 (9%) had a fracture of the neck of the radius; six were grade-IV injuries (1.9%). Five of the latter had an excellent postoperative result with normal movement of the elbow and forearm. One patient with a poor result had a concomitant dislocation of the elbow. Our results suggest that closed reduction and intramedullary pinning of grade-IV fractures allows adequate stabilisation while healing occurs


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 415 - 420
1 Feb 2021
Farr S Jauker F Ganger R Kranzl A

Aims

The aims of this study is to report the clinical and radiological outcomes after pre-, central-, and postaxial polydactyly resection in children from a tertiary referral centre.

Methods

All children who underwent resection of a supernumerary toe between 2001 and 2013 were prospectively enrolled and invited for a single re-assessment. Clinical parameters and several dedicated outcome scores (visual analogue scale (VAS), Paediatric Outcomes Data Collection Instrument (PODCI), Activities Scale for Kids (ASK), and American Orthopaedic Foot and Ankle Society Score (AOFAS)) were obtained, as were radiographs of the operated and non-operated feet along with pedobarographs.


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1048 - 1055
1 Aug 2020
Cox I Al Mouazzen L Bleibleh S Moldovan R Bintcliffe F Bache CE Thomas S

Aims

The Fassier Duval (FD) rod is a third-generation telescopic implant for children with osteogenesis imperfecta (OI). Threaded fixation enables proximal insertion without opening the knee or ankle joint. We have reviewed our combined two-centre experience with this implant.

Methods

In total, 34 children with a mean age of five years (1 to 14) with severe OI have undergone rodding of 72 lower limb long bones (27 tibial, 45 femoral) for recurrent fractures with progressive deformity despite optimized bone health and bisphosphonate therapy. Data were collected prospectively, with 1.5 to 11 years follow-up.