Tension band versus locking plate fixation for patella fractures - a protocol of a randomised controlled trial.

INTRODUCTION: Following surgical management of patella fractures, patients commonly report pain; difficulties with weight-bearing tasks such as walking, running and climbing stairs; and restrictions in quality of life. Recently, a locking plate system for surgical management of patella fractures has been introduced. To date, no studies have compared standard treatment with tension band wiring with locking plate fixation in a randomised study design. We aim to compare the one-year patient-reported Knee Injury and Osteoarthritis Outcome subscale scores (KOOS5-subscales) after standard care tension band fixation with locking plate fixation for patients with patella fractures. METHODS: This is a multicentre randomised and prospective clinical trial. A total of 122 patients will be included in the study, and the primary outcome will be the KOOS subscales at 12 months after surgery. CONCLUSIONS: Findings from the present study are expected to advance our understanding of outcome following surgical treatment of patella fractures. FUNDING: This study is funded, in part, by the Novo Nordisk Foundation, Denmark. CLINICALTRIALS: gov ID: NCT04891549.

Intramedullary nailing versus external ring fixator for treatment of tibial fractures - a study protocol for a randomised clinical trial.

INTRODUCTION: Tibial shaft fractures are among the most common lower extremity fractures. Treatment of tibial shaft fractures with intramedullary nailing has become the treatment of choice in adults. However, commonly reported outcomes include knee pain, limitations in activities of daily living and reduction in quality of life (QOL). The literature lacks high-quality studies to document superiority of intramedullary nailing versus other surgical treatment methods. The present study aims to compare the 12-month Knee Injury and Osteoarthritis Outcome Score (KOOS) - sport and recreation activities (sport/rec) after standard intramedullary nailing with external ring fixation for adult patients with isolated tibial shaft fractures. METHODS: This study is a multicentre randomised, prospective clinical trial. A total of 67 patients will be included in the study, and the primary outcome will be the KOOS-sport/rec at 12 months after surgery. CONCLUSIONS: With KOOS-sport/rec as the primary outcome, the findings of the present study are expected to advance our understanding of knee pain, function and QOL, regardless of the treatment option and the outcome of the study. FUNDING: The project is partially funded by the Independent Research Found Denmark. CLINICALTRIALS: gov ID: NCT-03945669, version 1.1, 21 September 2022.

Prospective evaluation of pin site infections in 39 patients treated with external ring fixation.

Introduction: Pin site infection is a common complication to external ring fixation. While the aetiology is well described, monitoring of onset, location, and the distribution of infection among the pin sites still needs further attention. The present pilot study evaluates the feasibility of a prospective registration procedure for reporting, evaluating, and monitoring of pin site infections in patients treated with external ring fixation. This may promote communication between team members and assist decision-making regarding treatment. Methods: A total of 39 trauma, limb deformity, and bone infection patients (15 female, 24 males; mean age 49 years (range: 12-88)) treated with external ring fixation were followed in the outpatient clinic using the pin site registration tool. Pin site infection (Checketts and Otterburn (CO) grade, onset, location), use of oral or intravenous antibiotics, and any unplanned procedures due to pin sites complications (wire removal and/or replacement, premature frame removal, amputation, etc.) were registered until frame removal. Results: The mean (SD) frame time was 164 (83) d (range: 44-499). We performed 3296 observations of 568 pin sites. Pin infection was registered in 171 of the 568 pin sites (30 %), of which 112 (65 %) were categorized as CO 1, 42 (25 %) as CO 2, 9 (5 %) as CO 3, and 8 (5 %) as CO 5. Neither CO 4 nor CO 6 was observed. A total of 35 patients (90 %) encountered CO 1-3 at least once during the observation time, while 1 patient (2.5 %) developed a major infection at eight pin sites (CO 5). Antibiotics were administered to 22 / 39 (56 %) of the patients. Conclusion: In an effort to monitor pin site infections in this complex patient group and to ensure the best clinical outcomes, our registration procedure in the outpatient clinic helped to recognize pin site infections early and eased communication between team members providing a concise overview of the treatment course.

Removal of broken PRECICE Stryde intramedullary lengthening nails.

This paper describes two different techniques for removal of broken Precice Stryde intramedullary bone lengthening nails, which unlike trauma nails are solid containing mechanical components. Consequently, surgeons face unique challenges when these implants brake within medullary canal. Here, we present our surgical approach for removal of three broken implants. In one patient (46kg) both Ø10mm femoral Stryde implants (max. weight allowance 68kg) broke through the proximal locking screw hole preoperatively on the right side and intraoperatively on the left side (413 and 504 days after index surgery respectively). The third Ø11.5 femoral nail broke through the area containing the magnet (55kg patient, 325 days after index surgery). LEVEL OF EVIDENCE: IV.

Pain, osteolysis, and periosteal reaction are associated with the STRYDE limb lengthening nail: a nationwide cross-sectional study.

Background and purpose - Observing serious adverse events during treatment with the Precice Stryde bone lengthening nail (NuVasive, San Diego, CA, USA), we conducted a nationwide cross-sectional study to report the prevalence of adverse events from all 30 bone segments in 27 patients treated in Denmark.Patients and methods - Radiographs of all bone segments were evaluated regarding radiographic changes in February 2021. We determined the number of bone segments with late onset of pain and/or radiographically confirmed osteolysis, periosteal reaction, or cortical hypertrophy in the junctional area of the nail.Results - In 30 bone segments of 27 patients we observed radiographic changes in 21/30 segments of 20/27 patients, i.e., 19/30 osteolysis, 12/30 periosteal reaction (most often multi-layered), and 12/30 cortical hypertrophy in the area of the junction between the telescoping nail parts. Late onset of pain was a prominent feature in 8 patients. This is likely to be a prodrome to the bony changes. Discoloration (potential corrosion) at the nail interface was observed in multiple removed nails. 15/30 nails were still at risk of developing complications, i.e., were not yet removed.Interpretation - All Stryde nails should be monitored at regular intervals until removal. Onset of pain at late stages of limb lengthening, i.e., consolidation of the regenerate, should warrant immediate radiographic examination regarding osteolysis, periosteal reaction, and cortical hypertrophy, which may be associated with discoloration (potential corrosion) of the nail. We recommend removal of Stryde implants as early as possible after consolidation of the regenerate.

Resect or Retain Bone Fragments in Children and Teenagers with Severe Open Fractures?: A Case Report.

CASE: A 14-year-old pedestrian was hit by a car and encountered similar bilateral Gustilo IIIB open tibial fractures. The right tibial fracture involved a large borderline vital butterfly fragment without periosteal contact, which was retained and proceeded to sufficient healing within 12 weeks. The left tibial fracture was treated according to the principles for the treatment of severe open fractures in adults, involving resection of devitalized fragments and bone transport, and healed within 15 months. CONCLUSIONS: Teenagers do possess larger bone healing potential than adults. Therefore, a rapid bone union can be achieved even with apparently devitalized bone fragments if sufficient soft-tissue closure and stable fracture fixation is established early in the treatment of open limb fractures.

The Joint Angle Tool for Intraoperative Assessment of Coronal Alignment of the Lower Limb.

AIM: Presentation of the joint angle tool (JAT), a low-cost goniometer for intraoperative assessment of the lower limb alignment. BACKGROUND: Intraoperative assessment of coronal alignment is important when performing corrective osteotomies around the knee and ankle, limb lengthening, and trauma surgery. JAT provides surgeons with information about the anatomic and mechanical axes intraoperatively based on true anteroposterior radiographs. TECHNIQUE: JAT consists of pre-printed joint orientation angles of the anatomic and mechanical axis including normal variations on a plastic sheet. It is placed on the screen of the image intensifier after obtaining a true anteroposterior image. The pre-printed joint orientation angles can assist the surgeons intraoperatively in achieving the pre-planned axis correction. Here, its feasibility is demonstrated in four cases. CONCLUSION AND CLINICAL SIGNIFICANCE: JAT is a modified goniometer that allows intraoperative assessment of the mechanical and anatomic axis. JAT is applicable throughout the entire surgical procedure irrespective of the method of internal fixation and may provide additional reassurance of correct alignment. JAT consists of a plastic sheet with printed joint orientation angles and their normal variation. JAT is freely available from profeedback.dk/JAT/JAT.pdf for use and modification according to the Creative Commons license (CC BY-SA 4.0) if this paper is attributed. HOW TO CITE THIS ARTICLE: Abood AA-H, Petruskevicius J, Vogt B, et al. The Joint Angle Tool for Intraoperative Assessment of Coronal Alignment of the Lower Limb. Strategies Trauma Limb Reconstr 2020;15(3):169-173.

Complex tibial fractures are associated with lower social classes and predict early exit from employment and worse patient-reported QOL: a prospective observational study of 46 complex tibial fractures treated with a ring fixator.

The long-term outcomes following complex fractures of the tibia are reported to carry a risk of knee pain, malalignment, articular injury and post-traumatic osteoarthritis. The main objective of this study was to account for the patient-reported quality of life (QOL) 12 months after ring fixator removal in patients with a complex tibial fracture. Secondary objectives included a review of the socio-economic characteristics of the patient group and the rate of return to work in the study period. A prospective follow-up study was conducted of 60 patients with complex fractures of the tibia treated with ring external fixation. Patient-reported outcomes, radiological outcomes and socio-economic status including employment status of the patients were obtained 12 months after frame removal. Forty-six patients completed the assessment 12 months after frame removal (77%). The mean age of the patient at the time of fracture was 54.6 years (range 31-86). There were 19 males and 27 females. At 12 months after frame removal, the mean EQ5D-5L index was 0.66 (CI 0.60-0.72). The mean EQ5D-5L VAS was 69 (CI 61-76). When this was compared to the established reference population from Denmark, the study population showed a significantly worse EQ5D-5L index. The majority of patients (87%) were in the lower social classes suggesting a higher degree of social deprivation in the study population. Twenty-seven per cent of patients who were employed prior to injury had returned to employment at approximately 19 months following fracture. The onset of post-traumatic osteoarthritis was present in the knee joint in 29% of patients following a proximal intra-articular fracture, whereas osteoarthritis was present at the ankle joint in 35% of patients following a distal intra-articular fracture 12 months after frame removal. This study indicates that at 12 months after frame removal there are poorer patient-reported QOL as when compared to reference populations. Furthermore, this study suggests that complex tibial fractures are associated with lower social classes and that only 27% of patients in this sample, who prior to injury were employed, had returned to employment at approximately 19 months after the injury.

A prospective observational study of 56 patients treated with ring fixator after a complex tibial fracture.

The objective of this prospective study was to evaluate the patient-reported outcomes for patients with complex tibial fractures treated with a ring fixator. The secondary aim was to analyse the variables affecting patient-reported outcomes and time to union. Fifty-six patients participated in the study. The mean age at the time of fracture was 56.5 years (range 30-86). All fractures united during the study period. The ring fixator was removed at an average of 25.3 weeks (range 9-53). During treatment, the function and QOL increased with time. Compared with an established reference population, the study population showed a significantly worse EQ5D-5L index both throughout the treatment period and 8 weeks after frame removal. 18% of patients reported mild to severe depression 8 weeks after frame removal.

No benefit of a proximal stem centralizer in cementing of a femoral prosthesis in human cadavers.

BACKGROUND AND PURPOSE: A proximal stem centralizer may be beneficial regarding cementing pressures, cement penetration, and stem alignment. We measured these parameters when cementing a mat-surfaced femoral component with and without the use of a proximal stem centralizer. MATERIAL AND METHODS: 8 femoral prostheses with proximal centralizers and 8 femoral prostheses without proximal centralizers were cemented according to third-generation cementing technique in 8 pairs of embalmed cadaveric femora. We recorded intramedullary pressures (peak levels, the area under the pressure curves and mean pressure) with 6 pressure transducers during stem cementation. Computer tomographic scanning of specimens was performed to evaluate stem alignment after surgery. Thickness of the cement mantle, cement penetration, and stem centralization at the metaphyseal part of the femur were measured on cross sections using stereology. RESULTS: There were no statistically significant differences in measured pressure and cement penetration values between the groups. There was similar cement distribution around the stems; however, in using a proximal centralizer, the cement mantle tended to be thinner laterally. Moreover, we found a larger variation in stem alignment on lateral projection in the proximal centralizer group. INTERPRETATION: No benefits regarding intramedullary pressures and cement penetration were obtained from cementation of a straight stem with a proximal stem centralizer. However, there was an increased risk of inferior stem positioning in the reamed medullary cavity using the centralizing device.

Calcium phosphate cement enhances primary stability of open-wedge high-tibial osteotomies.

We investigated if injectable calcium phosphate cement improves primary stability in open-wedge high-tibial osteotomy. A 10 mm open-wedge osteotomy was performed on eight pairs of preserved cadaver tibiae and seven pairs of composite (Sawbone) left tibiae. Osteosynthesis was performed with the Dynafix plate system. The gap resulting from surgery either was filled with 15 g injectable calcium phosphate cement in half the bones or was left untreated. The composite tibiae were loaded at a ramp speed of 20 mm/min up to 20 kN. The cadaver tibiae were exposed to 100 cycles with a maximum compressive force of 2,250 N. After 100 cycles of loading with 2,250 N, the final loaded displacement was 1.2 mm for the cadaver tibiae treated with injectable calcium phosphate cement as compared with 3.6 mm for the empty defects (P = 0.028). All the seven empty defect composite specimens failed prior to 20 kN (median 2.8 kN) as compared with five of the injectable calcium phosphate cement specimens (median 17 kN) (P = 0.005). The injection of injectable calcium phosphate cement following open-wedge osteotomy of the proximal tibia increases the initial stability of the bone as measured by load-to-failure and displacement after cyclic loading. Clinical studies are ongoing to investigate whether injectable calcium phosphate cement also has clinical advantage on wedge healing and stability.

No effect of Osteoset, a bone graft substitute, on bone healing in humans: a prospective randomized double-blind study.

We studied the effects of a newly marketed bone substitute, Osteoset, on bone healing in a tibial defect in humans. 20 patients undergoing an ACL (anterior cruciate ligament) reconstruction with bone-patella tendon-bone graft were block-randomized into 2 groups of 10 each. In the treatment group, the tibial defect was filled manually with Osteoset pellets, in the control group the defect was left empty. CTs of the defect were taken on the first day after the operation, 6 weeks, 3 and 6 months postoperatively. We found about the same amount of bone in the defect in the Osteoset and control groups after 6 weeks, 3, and 6 months. In the control group, but not in the Osteoset group, the bone volume increased from 6 weeks to 3 months. The Osteoset pellets were almost resorbed after 6 weeks.