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Fractures, Bone clinical trials

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NCT ID: NCT04451538 Recruiting - Malnutrition Clinical Trials

Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Start date: December 28, 2020
Phase: N/A
Study type: Interventional

Hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. Malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. This study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.

NCT ID: NCT04443998 Active, not recruiting - Clinical trials for Mandibular Fractures

Mandibular Fracture Reduction Using Bone Reduction Forceps

Start date: October 16, 2019
Phase: N/A
Study type: Interventional

Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.

NCT ID: NCT04441723 Recruiting - Hip Fractures Clinical Trials

Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures

Start date: January 11, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail. The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture. Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.

NCT ID: NCT04440631 Completed - Fractures, Bone Clinical Trials

Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection

IMPAT-ODRI
Start date: November 1, 2019
Phase:
Study type: Observational

The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.

NCT ID: NCT04438226 Completed - Hip Fractures Clinical Trials

Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral

APOLLO
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the posterolateral and the direct lateral approach. Currently there is no conclusive evidence which of these two approaches results in better patient outcomes. Objective: Assessing the patient outcome comparing the posterolateral with the direct lateral approach in patients being treated with cemented hemiarthroplasty after femoral neck fractures. Study design: A randomised controlled multi-center superiority trial and natural experiment with an economic evaluation alongside. Study population: All patients older than 18 years with a femoral neck fracture whereby treatment with cemented hemiarthroplasty is recommended according the national guidelines. Intervention: Treatment with cemented hemiarthroplasty using the posterolateral approach. Standard intervention to be compared to: Treatment with cemented hemiarthroplasty using the direct lateral approach. Main study parameters/endpoints: The primary outcome is the patient-rated quality of life (EQ-5D-5L) at 6 months after surgery. Secondary outcomes are: ADL functionality (KATZ), Balance test (SPPB), Tendency to Fall (FES-I), Pain (NRS), Re-interventions, Mobility, Discharge destination, Complications, and cost-effectiveness. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The different approaches in the two treatment arms of the randomised controlled trial are widely used techniques in the Netherlands and many of the outcome measures are part of the standard clinical follow-up after hip fracture. Therefore, there is no extra risk or burden for participating patients, except for the time to complete some additional follow-up measurements. The primary outcome measurement and secondary outcomes, will be assessed through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months postoperatively. The assessment of the Short Physical Performance Battery (SPPB) balance test, will be performed by one of the study researchers or nurse practitioner to protect continuity and feasibility.

NCT ID: NCT04437355 Completed - Clinical trials for Ankle Fracture - Lateral Malleolus

Operative Treatment of Ankle Fractures

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Patients who underwent operative treatment of an ankle fracture with or without following removal of the osteosynthetic material are examined by a specific ankle provocation test, a questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome compared to a healthy control group

NCT ID: NCT04432740 Completed - Clinical trials for Distal Radius Fracture

A Novel Splint Technique for Distal Radius Treatment

Start date: April 15, 2017
Phase: N/A
Study type: Interventional

There are many conservative treatment methods, including below arm cast, above arm cast, and sugar tong splint that aim to obtain maximum functional, clinical, and radiological results There are no clear indications with regard to the best treatment including conservative or surgical methods for the different fracture subtypes in distal radius fracture. The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.

NCT ID: NCT04432389 Recruiting - Tibial Fracture Clinical Trials

Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

ALLOB-TF2
Start date: January 8, 2021
Phase: Phase 2
Study type: Interventional

Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life. The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.

NCT ID: NCT04430205 Completed - Root; Fracture Clinical Trials

Repair of Vertically Fractured Root

Start date: July 15, 1991
Phase:
Study type: Observational

Aim and background: The aim of this retrospective observational study is to evaluate the survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF), after tooth restoration either with fracture-fragment adhesive bonding or with amalgam restoration. Materials and Methods: One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5 years), presenting complete or partial root fracture, were treated with adhesive restoration or non-adhesive restoration protocol (amalgam) between 1991 and 2019. Demographic and clinical variables were evaluated as predictors of extraction. Furthermore, the bone loss/recovery due to therapy for the fracture was radiographically evaluated at the one year follow-up. All cases were treated by the same operator, using a surgical microscope. Statistical analysis was performed with IBM SPSS Statistics. The study was approved by the ethical committee of Sistema Sanitario Nazionale (prot. N°2370CELazio1).

NCT ID: NCT04429217 Recruiting - Clinical trials for Lateral Malleolus Fracture

A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.

Start date: April 28, 2020
Phase: N/A
Study type: Interventional

The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing. The investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.