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Femoral Fractures clinical trials

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NCT ID: NCT04311892 Recruiting - Hip Fractures Clinical Trials

Hip Abductor Muscle Dysfunction After Nailing of Proximal Femoral Fractures, Incidence and Contributing Factors.

Start date: January 18, 2019
Phase:
Study type: Observational

Proximal femoral fractures(PFFs) are common with advancing age. Proximal femoral nail (PFN) is now increasingly used to fix unstable fractures. Studies have demonstrated that muscle strength deficit is significantly large after PFFs. N. Ivanova et al found that hip muscle isometric strength for the fractured leg was significantly decreased 1 week and 6 months postoperatively. Besides, a recent study done by Nitin Wale et al concluded that abductor weakness and trendeleburg gait are fairly common in patients treated with PFN and this complaint is often overlooked. Despite significant improvement in muscle function after at least 6 months of physiotherapy as demonstrated by previous studies, we didn't come over a study explaining the main causes of remaining abductor lurch in patients with united fracture of the proximal femur treated using proximal femoral nail (short type).

NCT ID: NCT04309539 Recruiting - Clinical trials for Proximal Femur Fracture

Which Analgesia is Better for Proximal Femoral Fractures?

Start date: September 21, 2020
Phase: N/A
Study type: Interventional

This patient population is typically elderly and frail. They are at risk of adverse effects secondary to inadequate pain management such as prolonged admissions and poor functional outcomes. Regional analgesia is preferred due to their opioid-sparing effects and reduction in related adverse effects but The analgesia from these blocks is only moderate and literature suggests that the obturator nerve (ON) is not covered.

NCT ID: NCT04306536 Recruiting - Femur Fracture Clinical Trials

Nutritional Support in Femur Fracture Rehabilitation

Start date: June 19, 2020
Phase: N/A
Study type: Interventional

This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

NCT ID: NCT04299022 Recruiting - Fractures, Bone Clinical Trials

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

NCT ID: NCT04076735 Recruiting - Clinical trials for Distal Femur Fracture

DIFFIR - Geriatric Distal Femur Fixation Versus Replacement

DIFFIR
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The current standard of care for most intra-articular distal femur fractures (above the knee joint) in geriatric patients is a surgical fixation using plates and screws to hold the fracture pieces in the correct position, until the fracture as healed. However, surgical fixation of these complex fractures in geriatric patients, is associated with significant complications, such as non-union (when the broken bone does not heal properly), infection and the need for revision surgery. Additionally, surgical fixation requires prolonged immobilization of of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Geriatric patients, especially those frail and with cognition impairment, are unable to adhere to the immobilization restrictions, which leads to an increased risk of fixation failure (broken bone does not heal). Another treatment option for those patients is an acute distal femoral replacement (artificial knee), where damaged parts of the knee joint are replaced with artificial prosthesis. This procedure allows patients to walk immediately after the surgery and faster return to previous level of function, therefore avoiding the complications for immobilization. There is a lack of guideline and evidence to suggest which surgical technique is best to provide superior function outcomes, lower complications and reduced costs. The proposed study seeks to answer this question by performing a large clinical trial comparing knee replacement versus surgical fixation in geriatric patients with distal femur fracture.

NCT ID: NCT04062604 Recruiting - Surgical Treatment Clinical Trials

The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment

ELLFF
Start date: September 1, 2019
Phase:
Study type: Observational

The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.

NCT ID: NCT04048980 Recruiting - Dementia Clinical Trials

Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units

CARExDEM
Start date: July 30, 2018
Phase: N/A
Study type: Interventional

This is a quasi-experimental design with repeated observations, taken at baseline, post-intervention, and at one and three months post-intervention. Participants will be patients hospitalized with cognitive disorders o dementia and a femur fracture. The study will be developed in four general hospitals in Spain and will include 430 patients with dementia (PwD) and their informal caregivers (IC). The study sample will be assigned to the control group (n=215) from each hospital involved and will receive the standard treatment. After completing the recruitment for the control group, the investigators will start to recruit patients until experimental patient group is complete (n=215) from each hospital to whom the CARExDEM intervention will be implemented.

NCT ID: NCT04015154 Recruiting - Femoral Fracture Clinical Trials

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF

Start date: September 12, 2019
Phase:
Study type: Observational

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 50 subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 29 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

NCT ID: NCT04015128 Recruiting - Femoral Fracture Clinical Trials

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT

Start date: September 12, 2019
Phase:
Study type: Observational

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

NCT ID: NCT03868280 Recruiting - Femur Fracture Clinical Trials

The FLiP Study, a Pilot Cluster Randomized Trial

FLiP
Start date: October 16, 2020
Phase: N/A
Study type: Interventional

The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of lateral patient positioning versus supine positioning with fracture table use for reamed antegrade intramedullary fixation of femur fractures.