Active clinical trials for "Humeral Fractures"

Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. In the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.

The proposed project will be a multi-centre, prospective observational study to determine the prognosis and determinants of functional outcomes of patients with proximal humerus fractures. Approximately 10 centres will participate in this observational cohort, each enrolling at least 50 patients over the course of 2 years.

Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers. Our aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement. Hypothesis: Mobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales. Objectives: Primary objective: To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care. Secondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application. Methods: Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial. Total 60 subjects required with 30 in each arm in 24-month duration. Study procedures: Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded. Written informed consent will be administered the study subjects as per GCP guideline. Each eligible patient will be randomized into intervention or control group. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively. Control group: Routine care will be provided to control group and as per routine. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious/Adverse event (SAE/AE), any patient who experience SAE/AE, will receive good clinical care at earliest and all relevant reporting bodies will be notified. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years. Statistical Consideration: Quantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs/SAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%. Patient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.

The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.

The purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Proximal humerus fractures (break of the top part of the upper arm bone) are common in older people with poorer bone quality. Often patients do not undergo surgery for these fractures: the bone fragments may be in an acceptable enough position to be able to heal naturally, or the patient may not be well enough medically to undergo an operation. These patients need to wear a sling to immobilise their injured shoulder, however muscles start to weaken quickly when they are unable to be used. This research project will look at whether strength-training the opposite/uninjured limb, known as "cross education", has any effect on preserving the function of the injured/fractured limb. Participants will be randomised into two groups using minimisation, that is to say the groups will have balanced numbers in terms of exact pattern of fracture and gender. One group will receive traditional rehabilitation exercises and treatment by the physiotherapist for their injured limb; the other group will receive the same but in addition will also undergo a strength-training exercise programme for their uninjured limb. Only qualified physiotherapists with experience of treating this patient cohort will be involved. Sessions in the physiotherapy department will last up to 30 minutes each and will comprise of: patient review, exercise progression, and advice giving/question answering; home exercise programmes will be expected to be completed 2-3 times daily and last up to 30 minutes each; number of sessions will be agreed between the participant and treating physiotherapist with treating ending once an agreed, acceptable level of function has been achieved. The Oxford Shoulder Score patient-reported outcome measure will be completed by the participant at 6 and 12 weeks and the European Quality of Life (EuroQoL)-5D-5L at 12 weeks after commencement of treatment.

To determine the effectiveness of 500 cGy dose of radiation therapy vs. an untreated group in the prophylactic treatment of heterotopic ossification in distal humerus fractures

Failure rates of up to 30% are reported after proximal humeral fractures despite angular-stable devices. This may devastate not only the functional outcome but also the independence of elderly patients. To increase bone mineral density and thereby holding-strength augmentation is an option. Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis since osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose tissue seems an alternative cell-source even in presence of osteoporosis. Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and vasculogenic potential and can be harvested in high numbers. Expansion associated with costly good-manufacturers-practice facilities is avoidable, so are repeated interventions. These cells have been successfully used to generate osteogenic composite grafts with intrinsic vascularity in preclinical models. For translation into clinical practice after a 20 patient external pilot a prospective randomized controlled trial with 270 patients is planned. For the trial lipoaspiration precedes open reduction and internal fixation in individuals over 60 years presenting with a proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS) and wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for augmentation of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks for immediate complications and after 6, 9 and 12 months. Functional assessment is performed after 6 weeks, 6 and 12 months using the Quick-Dash- and Constant-Score. The primary outcome is a reduction in secondary dislocation by 50% during the first postoperative year. Secondary dislocation is diagnosed on plain radiographs by an independent board certified radiologist specialised in musculoskeletal imaging if one or more of the following criteria are met: More than 20° varus collapse of the humeral head fragment in relation to the humeral shaft Screw penetration through the humeral head

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.