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The impact of clinical data on the evaluation of tibial fracture healing.

ABSTRACT: Radiographic healing is a common outcome measure in orthopedic trials and adjudication by outcome assessors is often conducted on the basis of plain films alone. The degree to which this process reflects clinical practice, in which both plain films and clinical notes are available, is uncertain. We explored the effect of adding clinical notes to radiographs in the adjudication process of a feasibility trial of tibial shaft fractures.Radiographic and clinical data from a multicenter randomized controlled trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. At the completion of the trial, serial radiographs (anteroposterior and lateral) were independently evaluated for progression of fracture healing, defined as bridging of at least 3 of 4 cortices, by an adjudication committee comprised of 3 blinded orthopaedic trauma surgeons. Immediately after determination of radiographic time to healing, each surgeon was provided with clinical notes associated with each radiographic follow up visit and asked to re-visit their initial impression. Consensus was achieved for both adjudications. We calculated the percentage of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of clinical notes and their relative influence on the committee's decisions.47 of 51 patients were determined to have healed radiographically during the trial follow-up period, and consideration of clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing. Clinical notes that resulted in a change to either a 'healed' or a 'not healed' decision contained significantly more comments of either pain resolution or deterioration, respectively, resumption of or failure to resume weightbearing, or either return or no return to work/pre-injury activities (p < 0.001).The addition of clinical notes to the adjudication of radiographic fracture healing changed the outcome decision in a substantial number of cases. Orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing in order to enhance the generalizability of their results.The TRUST trial was registered [ID NCT00667849] at http://clinicaltrials.gov/ct2/show/NCT00667849.

SUBMITTER: Dijkman BG

PROVIDER: S-EPMC3254075 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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The impact of clinical data on the evaluation of tibial fracture healing.

Dijkman Bernadette G BG Busse Jason W JW Walter Stephen D SD Bhandari Mohit M

Trials 20111103

<h4>Background</h4>Radiographic healing is a common outcome measure in orthopedic trials and adjudication by outcome assessors is often conducted on the basis of plain films alone. The degree to which this process reflects clinical practice, in which both plain films and clinical notes are available, is uncertain. We explored the effect of adding clinical notes to radiographs in the adjudication process of a feasibility trial of tibial shaft fractures.<h4>Methods</h4>Radiographic and clinical da ...[more]

PMID: 22050862

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Project description:BackgroundThis study was to evaluate the effects of repetitive brief ischemia (RBI) on bone healing in patients with tibial shaft fractures.MethodsIn this prospective clinical trial, patients with tibia shaft fractures were enrolled between January 2016 and January 2021. The intermittent pneumatic compression (IPC) device was used to make RBI on the affected limb after surgical operation 24 h. The inflation pressure was the systolic pressure of patients + 50 mmHg. Patients were received 30 s inflation/30 s deflation 30 times twice a day for 4 weeks. The primary outcome was bone healing time and the secondary outcomes were the rates of delayed union and nonunion, the rates of venous thrombosis of lower limbs, Johner-Wruhs scores, Lysholm knee score, VAS scores, postoperative complications, serum BMP-2, osteocalcin (OC) and bone specific alkaline phosphatase (BS-ALP).ResultsA total of 32 patients were enrolled finally and all were completed with a 12 months follow-up. All the fractures were healed and the bone healing time was 3(1) months in RBI group. However, the bone healing time of control group was 4(1) and there was statistical difference between the two groups (p < 0.01). No patient with fracture delayed union, nonunion and venous thrombosis of lower limbs in RBI group. 2 patients were delayed union in the control group. In RBI group, the Lysholm knee score was 83(6) at 6 months and 100(8) at 12 months. In the control group, the score was 78(4) and 90.5(17), there was statistical difference between the two groups (p < 0.01, p = 0.014, respectively). VAS scores were postoperative 2 weeks 6(1) in RBI group and 7(0.5) in the control group, there was statistical difference between the two groups (p = 0.016). There were 2 patients with intramuscular venous thrombosis of lower extremity in control group. Besides, RBI treatment increased the serum BMP-2, OC and BS-ALP at postoperative 2 weeks and 1 month.ConclusionsRBI is a new method to accelerate bone healing in tibia shaft fracture patients and is a simple and noninvasive method.Trial registrationChinese clinical trial registry, ChiCTR-INR-17014208 . Registered 28 December 2017-Retrospectively registered.

Project description:To explore the influence of hyperhomocysteinemia (hHcys) on the tibial fracture healing in rats and its effect on the phosphatidylinositol 3-hydroxy kinase (PI3K)/protein kinase B (AKT) signaling pathway. A total of 36 Sprague-Dawley rats were randomly divided into sham group (n=12), tibial fracture group (n=12) and hHcys + fracture group (n=12). The rats in tibial fracture group underwent the tibial fracture surgery, while the model of tibial fracture and hHcys was established in hHcys + fracture group. The level of plasma homocysteine (Hcy) in each group was analyzed using the full-automatic biochemical analyzer, the fracture stress biomechanical measurement was performed, and the ultimate bending strength and torque were calculated. Moreover, the protein expressions of PI3K and phosphorylated (p)-AKT in tibial tissues were detected using western blotting, the messenger ribonucleic acid (mRNA) levels of Bcl-2 associated X protein (Bax) and caspase-3 were detected using quantitative polymerase chain reaction (qPCR), the apoptosis was detected via terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) staining, and the expressions of inflammatory factors were detected via immunohistochemistry. Compared with sham group, tibial fracture group and hHcys + fracture group had a significantly increased level of plasma Hcy, significantly decreased ultimate bending strength and torque, obviously decreased relative protein expressions of PI3K and p-AKT, increased mRNA levels of Bax and caspase-3 and an increased expression of pro-inflammatory factor tumor necrosis factor-? (TNF-?). Compared with tibial fracture group, hHcys + fracture group had a higher level of plasma Hcy, lower ultimate bending strength and torque, lower relative protein expressions of PI3K and p-AKT, higher mRNA levels of Bax and caspase-3, a higher apoptosis rate and a higher expression of TNF-?. hHcys blocks the downstream apoptotic signal transduction, promotes apoptosis and inflammatory response, and affects fracture healing through affecting the PI3K/AKT signaling pathway.

Project description:BackgroundAt present, bone union delay or failure remains challenging for clinicians. It has been reported that adipose-derived mesenchymal stem cells (ADMSCs) offer a promising way to promote bone fracture healing. In recent years, nanomaterials have been applied in regenerative medicine. This study aimed to investigate whether ADMSCs combined with platinum nanoparticles (PtNPs) could further improve fracture healing on the basis of ADMSCs.MethodsADMSCs were co-cultured with PtNPs in vitro to investigate the effect of PtNPs on the differentiation of ADMSCs. Twenty Sprague-Dawley (SD) rats were randomly divided into four groups (with five rats in each group). The left tibias of all rats were fractured. Phosphate-buffered saline (PBS), PtNPs, ADMSC, and ADMSC mixed with PtNPs were then injected into the fracture sites based on the group classifications. The fracture was monitored by X-ray immediately after the fracture and on days 14 and 28 post-fracture. The tibias of the rats were subsequently harvested after the last X-ray and evaluated by micro computed tomography (micro-CT), histological analysis, and immunohistochemical detection.ResultsPtNPs significantly enhanced the osteogenic differentiation of ADMSCs in vitro. On days 14 and 28 post-fracture, the radiographic score of the ADMSC + PtNPs group was higher than that of the ADMSC group, the score of the ADMSC group was higher than that of the PtNPs and control groups, and there was no significant difference between the PtNPs and control groups. Micro-CT confirmed that combined ADMSCs with PtNPs were more effective than using ADMSCs alone in promoting fracture healing. The histological and immunohistochemical results further supported this conclusion.ConclusionsOur findings demonstrated that PtNPs could promote osteogenic differentiation of ADMSC in vitro. ADMSCs combined with PtNPs could accelerate fracture healing further in vivo and are a promising a potential method for the treatment of fracture healing.

Project description:Introduction and importance: Unicondylar tibial plateau fractures with tibial shaft fractures are extremely rare among the elderly group of people. The traditional treatment method is to apply double plates to fix unicondylar tibial plateau fractures combined with tibial shaft fractures respectively, but this fixation method can disrupt the blood supply around the soft tissues and increase the rate of postoperative infection and fracture non-union. In this paper, we would analyse an old unicondylar tibial plateau fracture (Schatzker type III) with tibial shaft fracture which admitted to our department and discussed the efficacy of using intramedullary nails and plates in the treatment of these fractures. Case presentation A 78-year-old woman with an old unicondylar tibial plateau fracture combined with tibial shaft fracture was presented in this case. Using an intramedullary nail combined with a plate to achieve good results. Clinical discussion This case represents a rare case of an unicondylar tibial plateau fracture with a tibial shaft fracture. In this case, the tibial plateau fracture was first incised and internally fixed with a 9-hole plate across the fracture line of the tibial shaft, followed by fixing the tibial shaft fracture with an intramedullary nail. This treatment helped us successfully reset the unicondylar tibial plateau fracture with tibial shaft fracture and provided a satisfactory outcome for the patient. Conclusion Using intramedullary nails combined with plates to treat unicondylar tibial plateau fractures with tibial shaft fractures allowed for a predictable healing result. Highlights • Unicondylar tibial plateau fractures with tibial shaft fractures are extremely rare in the elderly.• Traditional double plate internal fixation seriously affected soft tissue and bone healing.• The use of plates in combination with intramedullary nails can reduce the destruction of soft tissue and fix both the tibial plateau and the tibial shaft.

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The impact of clinical data on the evaluation of tibial fracture healing.

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The impact of clinical data on the evaluation of tibial fracture healing.

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