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Fractures, Bone clinical trials

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NCT ID: NCT01973712 Recruiting - Clinical trials for Periprosthetic Fractures

Periprosthetic Distal Femur Fracture

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

A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture. Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur. The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.

NCT ID: NCT01963039 Completed - Osteoporosis Clinical Trials

A Trial of Vertebroplasty for Painful Chronic Osteoporotic Vertebral Fractures (Vertos V)

VERTOSV
Start date: May 2013
Phase: N/A
Study type: Interventional

Background The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a relatively new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs in patients with acute VCFs. A still ongoing masked RCT (VERTOS IV) focuses on acute VCFs defined as ≤ 6 weeks. VERTOS III focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. These patients with sustained pain after 3 months may benefit from PV. Objective To compare pain relief after PV with a sham intervention in selected patients with a chronic osteoporotic VCF ( three months or longer) using the same strict inclusion criteria as in VERTOS II an IV. Secondary outcome measures are back pain related disability and quality of life. Methods The VERTOS V study is a prospective RCT with pain relief as primary endpoint. Inclusion criteria are a VCF of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a Visual Analogue Scale (VAS) score ≥ 5 for three months or longer, decreased bone density defined as T score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during one year period with VAS score for pain as primary endpoint. Secondary endpoints are back pain related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Conclusion Vertos V is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.

NCT ID: NCT01961895 Completed - Hip Fractures Clinical Trials

Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture

Start date: May 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.

NCT ID: NCT01955577 Not yet recruiting - Tibial Fracture Clinical Trials

Vitamin D Supplement for Patients With Tibial Fracture

Start date: April 2015
Phase: Phase 1
Study type: Interventional

The purpose is to study: 1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator 2. if vitamin D supplement facilitates fracture healing 3. a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing

NCT ID: NCT01950169 Completed - Hip Fracture Clinical Trials

Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

Start date: December 2004
Phase: N/A
Study type: Interventional

The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.

NCT ID: NCT01940536 Withdrawn - Hip Fracture Clinical Trials

The Effect of Tranexamic Acid on Transfusion Rates in Intertrochanteric Hip Fractures

Start date: December 2015
Phase: Phase 4
Study type: Interventional

The goal of this study is to determine if the use of tranexamic acid, a safe and effective antifibrinolytic, in patients with intertrochanteric hip fractures will result in a reduction in blood transfusion rates. Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, cost of inpatient care, and rate of adverse events, including DVT, PE, infection, MI, cerebrovascular event, need for re-hospitalization or re-operation and 30 day mortality.

NCT ID: NCT01939015 Completed - Clinical trials for Displaced Mandibular Angle Fracture

Three Dimensional Versus Standard Miniplate In Fixation Of Mandibular Angle Fracture- A Prospective Randomized Controlled Clinical Trial

RCTs
Start date: February 2013
Phase: N/A
Study type: Interventional

- The aim of this study is to compare the standard and 3D miniplates fixation in mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain, hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one method over the other. - Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded and treated. The clinical evaluations will be performed by 1 surgeon at each institution. - The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor. - Statically analysis : Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.

NCT ID: NCT01934946 Recruiting - Hip Fracture Clinical Trials

Rehabilitation Care for Hip Fracture

Start date: September 2013
Phase: N/A
Study type: Interventional

Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no adequate rehabilitation was given. The aim of the study is to compare the effectiveness of different types of post acute rehabilitation care for hip fracture.

NCT ID: NCT01934387 Completed - Osteoporosis Clinical Trials

Geriatric Health Exam Osteoporosis Screening

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

BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population. OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults participating in the geriatric health examinations (GHEs) at the National Taiwan University Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. The second aim is to look for the recommendations from the participating physicians to improve the FRAX® -based osteoporosis management model. METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE visits after informed consent. Baseline questionnaires including the FRAX® tools will be distributed and expected to be returned at the stage 2 visits. Research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the GHE physicians. High risks individuals will be referred to general geriatric clinic for further managements. All participants will be provided with osteoporosis and fracture educational material. Patient acceptance and awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%. Qualitative interviews will be used to obtain recommendations from study geriatricians in Jul., 2013 to optimize the FRAX® based screening and management model.

NCT ID: NCT01930409 Completed - Hip Fracture Clinical Trials

Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture

B2F
Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.