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Fractures, Bone clinical trials

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NCT ID: NCT01532076 Terminated - Clinical trials for Osteoporotic Fractures

Effectiveness of Adipose Tissue Derived Mesenchymal Stem Cells as Osteogenic Component in Composite Grafts

ROBUST
Start date: June 2012
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT01527812 Completed - Clinical trials for Fractured Neck of Femur

Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery

Start date: December 2009
Phase: N/A
Study type: Interventional

The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.

NCT ID: NCT01524965 Recruiting - Humeral Fracture Clinical Trials

The Effect of the Timing of Postoperative Mobilisation After Locking Plate Osteosynthesis of Fractures of the Surgical Neck of the Humerus

Start date: May 2011
Phase: N/A
Study type: Interventional

Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.

NCT ID: NCT01520480 Completed - Clinical trials for Subtrochanteric Femur Fractures

Pathological Subtrochanteric Fractures in 194 Patients

Start date: January 1999
Phase: N/A
Study type: Observational

In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.

NCT ID: NCT01520298 Withdrawn - Pain Clinical Trials

Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients

Start date: December 2011
Phase: Phase 3
Study type: Interventional

This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.

NCT ID: NCT01518179 Completed - Clinical trials for Distal Radius Fractures

Compression Gloves for Distal Radius Fracture

Start date: April 2012
Phase: N/A
Study type: Interventional

Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength. Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF). This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF. Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture. ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures): S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4). S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)

NCT ID: NCT01514643 Active, not recruiting - Clinical trials for Intraarticular Fracture and Post-traumatic Osteoarthritis

Inflammatory Response Following Intraarticular Fracture

PTOA
Start date: October 2011
Phase:
Study type: Observational

The purpose of the study is to investigate a relationship between the inflammatory response following intraarticular fracture and post-traumatic osteoarthritis. The investigators plan to evaluate the inflammatory cytokine profile in knee joint synovial fluid and blood serum in patients who sustain an intraarticular tibial plateau fracture and ankle joint synovial fluid and blood serum in patients who sustain an intraarticular tibial plafond fracture. This information will be combined with radiographs and patient outcome measures to determine a correlation between intraarticular inflammatory response and post-traumatic osteoarthritis.

NCT ID: NCT01514097 Recruiting - Fracture Clinical Trials

Adequacy of Pain Management for Upper Extremity Fracture After Discharge From a Pediatric Emergency Depart

Start date: February 2012
Phase: N/A
Study type: Observational

Pain is a common cause for children seeking care in the Emergency Department (ED). Children with orthopedic injuries often require pain control when seeking emergency care. Despite the high prevalence of ED visits requiring pain control, pain is often poorly assessed and treated in ED settings. Currently, no standard of care exists for the management of this fracture-related pain in children discharged from the ED. Furthermore, discrepancies in analgesia administration to patients of various racial groups seeking emergency care have been documented but are poorly understood. No research currently exists comparing pain severity between upper extremity fractures requiring simple splinting to those treated with sedated reduction and splinting. Furthermore, there is no research regarding the prevalence of significant post-discharge pain nor the differences among ethnic and age groups treated in the ED. Research Questions: What is the prevalence of significant post-discharge pain in children treated for upper extremity fractures? Is there a difference in severity between those children requiring reduction versus simple splinting? Is there a difference in pain severity noted among different ethnic or age groups? Design This is a prospective, un-blinded, observational study that will include patients seeking treatment for an upper extremity fracture.

NCT ID: NCT01509859 Recruiting - Clinical trials for Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur

Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture

Start date: December 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.

NCT ID: NCT01509118 Recruiting - Clinical trials for Open Fracture of Hip

Rivaroxaban Safety Profile in the Prophylaxis of Venous Thromboembolism After Hip Fracture Surgery

Start date: July 2011
Phase: N/A
Study type: Observational

Arterial and venous thromboembolism represents one of the most common preventable health problems. Patients undergoing surgery, especially hip fracture surgery are at high risk for deep vein thromboembolism (VTE) without thromboprophylaxis. In the absence of prophylaxis, the incidence of fatal pulmonary embolism (PE) after Hip Fracture Surgery (HFS) is reportedly 4%-12%. Provision of thromboprophylaxis to all patients who undergo HFS is recommended.