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Fractures, Bone clinical trials

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NCT ID: NCT02190435 Completed - Clinical trials for Intertrochanteric Femur Fractures

Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures

Start date: July 2014
Phase: N/A
Study type: Interventional

There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has become a well-accepted and increasingly more common procedure among orthopaedic traumatologists, and is standard of care at our institution. While advancements in intramedullary nail fixation have made it a relatively efficient procedure, the placement of the lag screw into the femoral head still remains a challenging step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most commonly reported complications with IM nail fixation. Previous work has shown that the lag screw position is an important factor in reducing screw cut-out. This step of the procedure can be time demanding and often requires several intraoperative radiographs for accurate placement. Recently developed computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved screw placement and potentially reduce radiation exposure to the patient and surgeon. To date, the potential advantages of computer-assisted navigation have not been examined. The primary objective of this study is to examine whether the use of Stryker's ADAPT computer-assisted navigation for Gamma nail fixation can result in improved lag screw placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a difference in the lag screw placement (i.e. tip to apex distance measurement) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation. Additionally, we hypothesize that there is a difference in radiation exposure (i.e. fluoroscopy time) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.

NCT ID: NCT02188836 Completed - Clinical trials for Fracture, Closed, Comminuted, Healing

Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures

Start date: January 2008
Phase: Phase 3
Study type: Interventional

This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators. The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.

NCT ID: NCT02177565 Completed - Clinical trials for Non-union of Fractures

Autologous Stem Cell Therapy for Fracture Non-union Healing

Start date: January 2000
Phase: N/A
Study type: Interventional

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

NCT ID: NCT02171897 Completed - Clinical trials for Pertrochanter Fracture

Pertrochanter Arthroplasty Versus Osteosynthesis

PAVO
Start date: January 29, 2015
Phase: N/A
Study type: Interventional

This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement. The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year. The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.

NCT ID: NCT02170545 Completed - Avascular Necrosis Clinical Trials

CT Imaging Evaluation of Humerus Fractures

Start date: March 2014
Phase:
Study type: Observational

Displaced, multi-part intracapsular, proximal humerus fractures represent a major challenge for patients and orthopedic surgeons. Proximal humerus fractures represent the third most common fracture after hip and distal radius fractures, and more than 20% of these fractures meet operative indications. Unfortunately, one of the major complications of these fractures is the development of avascular necrosis (AVN), or death of the bone as a result of the loss of blood supply to it. Currently, the ability to predict AVN is limited. The purpose of this study is to determine if computed tomography imaging can identify a quantifiable predictor of AVN following this type of humeral fracture.

NCT ID: NCT02170493 Completed - Clinical trials for Lower Extremity Fractures

Insole Sensor to Determine Optimal Limb Loading

Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing. To meet this purpose, two specific aims have been developed. Specific Aim 1: Preclinical validation of a load-monitoring insole The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load monitoring: development of load sensor technology that is affordable, accurate and capable of monitoring for over four weeks. To develop this sensor technology into a load-monitoring insole, the Hitchcock lab will incorporate consumer type electronics into the design, including a microprocessor, battery, and data storage media. Following construction of a functional load-monitoring insole, a pilot human study with orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify modes of device failure, improve device interfacing and develop data handling protocols and software for the clinical arm of the proposed study. Specific Aim 2: Conduct a prospective, direct observational cohort study. Thirty (30) open tibial fracture patients will be recruited at two centers: University of Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking boot instrumented with the load-monitoring insole that will continuously record limb loading and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire regarding subjective perception of patient compliance will be collected at the first and last follow-up visits. Data collected from the insole sensor will be correlated to objective measures of fracture healing and subjective measures of patient compliance to determine the effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop software to process and summarize data from the load monitoring insole and continually improve human interfacing factors of the load monitoring insole based off of feedback from the clinical team and study participants.

NCT ID: NCT02168959 Completed - Clinical trials for Tibial Plateau Fracture

Continuous Femoral Nerve Block With a Tibial Plateau Fracture

Start date: February 2013
Phase: Phase 0
Study type: Interventional

The primary purpose of the proposed study is to compare postoperative pain scores and total opioid consumption between two groups randomized to either receive or not receive a femoral nerve block for pain control following surgical repair of a tibial plateau fracture. Pain will be assessed post-operatively using standard numeric pain scores rated on a 0 - 10 scale, as well as using the University new pain assessment tool - the Clinically Aligned Pain Assessment (CAPA). This new 5 question pain assessment tool has not yet been validated, but does address several key questions, including patient comfort, pain control, change in pain status, daily functioning, and sleep quality. Along with post-operative pain scores, we will compare total opioid consumption between the two groups. The null hypothesis is that there is no difference in pain scores or total opioid consumption between patients receiving a femoral nerve block and those without a nerve block following surgical repair of a tibial plateau fracture. A secondary outcome will examine long-term pain control, range of motion, and functional status of these patients at their regular orthopedic clinic follow-up appointments. The same pain scores will be assessed, along with quadriceps strength and knee range of motion. Patients will complete the PROMIS Physical Function CAT and short Musculoskeletal Function Assessment, patient reported outcomes tools to evalute physical function. A teriary outcome will be to retrospectively examine postoperative pain scores and total opioid consumption for all tibial plateau fracture patients seen at the University of Utah for surgical repair in the past 10 years.

NCT ID: NCT02155595 Completed - Osteoporosis Clinical Trials

Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

NIH fracture
Start date: May 2014
Phase:
Study type: Observational

The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate. In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments…i.e., "the right treatment for the right patient for right duration."

NCT ID: NCT02154620 Completed - Clinical trials for Distal Radius Fracture

Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

70
Start date: April 2013
Phase: N/A
Study type: Interventional

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination. An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study. A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.

NCT ID: NCT02152761 Completed - Clinical trials for Muscle Wasting (Atrophy) After Hip Fracture Surgery

Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

Start date: September 16, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.