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Fractures, Bone clinical trials

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NCT ID: NCT00908895 Completed - Radius Fractures Clinical Trials

Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Start date: April 2003
Phase: Phase 3
Study type: Interventional

The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function. The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.

NCT ID: NCT00907296 Completed - Fracture Healing Clinical Trials

Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

STARTT
Start date: September 2, 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

NCT ID: NCT00904137 Terminated - Clinical trials for Type I Supracondylar Fracture of the Humerus

Treatment of Type I Supracondylar Fractures of the Humerus

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

Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years. Many different treatment options exist to treat this type of fracture. The purpose of this study is to compare three different treatment modalities with regards to pain experienced during treatment, the amount of pain medication needed during treatment, and any short-term complications. We hypothesize that above elbow casting and long-arm splinting will result in less pain and have fewer complications than taping the elbow in flexion.

NCT ID: NCT00888550 Completed - Tibia Fracture Clinical Trials

Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Start date: August 2007
Phase: N/A
Study type: Interventional

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience. The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.

NCT ID: NCT00888160 Completed - Femur Fracture Clinical Trials

Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care

Start date: September 2010
Phase:
Study type: Observational

Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates. However, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood. The practice of "early total care," early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response. The alternative extreme of "damage control orthopedics (DCO)" has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation. It is speculated that DCO will diminish the potential for systemic compromise. However, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial. The investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome. The investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.

NCT ID: NCT00884988 Suspended - Fracture Clinical Trials

Lymphomyosot for Ankle Edema Following Fracture

Start date: February 2010
Phase: Phase 2
Study type: Interventional

Ankle fractures are invariably complicated by severe soft-tissue swelling which can significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a non-prescription, homeopathic complex drug which has been used for more than 70 years throughout Europe and the U.S., primarily for tissue edema and swelling. This is a randomized, placebo-controlled, double blind pilot study evaluating the effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment. The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult patients (age 18 years and older) admitted to the orthopedic department with acute ankle fractures which require ORIF repair will be assessed for inclusion in this study. The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and analgesic use); duration of hospital stay; and complications such as poor wound healing, blisters, and the development of deep vein thrombosis.

NCT ID: NCT00880529 Terminated - Rib Fractures Clinical Trials

Pain Relief for Ventilated Patients With Multiple Rib Fractures Using the ON-Q Pain Relief System

ON-Q
Start date: February 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to find out if patients having the ON-Q post-op Pain Relief System for pain management of multiple rib fractures will require fewer ventilator days, and will need less IV pain medicine to control their pain, and as a result have improved respiratory function during their recovery. The standard of care for providing pain relief for rib fractures is to use an opioid drug that is injected into the vein but also has side effects. Increased doses can lead to over sedation and consequently lead to difficulty with breathing. The ON-Q pain relief systems uses a local anesthetic under the skin. The anesthetic is called bupivicaine, and it is delivered from a thin tube approximately 10 inches long is tunneled under the skin along the back and parallel to the spine. The medication is stored in an elastic pump which delivers a slow continuous drip of medication from multiple holes in the tubing. Subjects will be randomized to either standard intravenous opioid pain management or the ON-Q pain relief device with supplemental opioid medication if needed. The device will remain in use until the subjects are able to breathe without the ventilator.

NCT ID: NCT00878319 Active, not recruiting - Clinical trials for Humeral Diaphyseal Fracture

Operative and Nonoperative Treatment of Humeral Shaft Fractures

Start date: August 19, 2009
Phase: N/A
Study type: Interventional

The purpose of this research study is to compare two different ways of treating a broken arm (fractured humerus) using either, the nonoperative approach or the operative, open reduction and internal fixation (ORIF). The study will examine which treatment will overall give better results in regards to shoulder and elbow function, residual pain and deformity. Patients who agree to consent to participation in this study will be randomly selected to receive one of the two treatment methods: 1. Nonoperative: This method requires the application of a plaster sugartong splint for 10 - 14 days followed by a transition to a functional (coaptation) brace to be worn for 4-6 weeks. Patients will be followed by physiotherapy from the baseline visit at 2 weeks. 2. Operative: This treatment option involves an operative procedure for fixation of the broken bone with plates and screws (open reduction internal fixation - ORIF). With this method of treatment, a splint or sling is worn for comfort postoperatively. The patient will be followed by physiotherapy after the post-operative visit at 2 weeks. Standard follow-up clinic visits at 2 weeks, 6 weeks, 4 months, 6 months and 12 months will be arranged from the date of randomization. The patient will be asked to complete two questionnaires, reporting the level of wellbeing and physical function. These questionnaires will be given to the patient at the time of baseline visit at 2 weeks and again at 6 weeks, 4 months, 6 months and 12 months. They should take approximately 10 - 20 minutes to complete. At each appointment, the patients will be x-rayed until healing has occurred, examined and evaluated (Constant Shoulder Score) by the surgeon and followed by physiotherapy for gentle range of motion (ROM) exercises progressing to strengthening and proprioception of the elbow and shoulder.

NCT ID: NCT00875992 Completed - Tibial Fractures Clinical Trials

Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures

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

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. The play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to enhance axial and angular fracture stability. ASLS provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with ASLS. This hypothesis will be tested in the present randomized controlled study.

NCT ID: NCT00873548 Completed - Clinical trials for Trochanteric Fractures

Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia

Start date: November 2007
Phase:
Study type: Observational

The primary objective of this prospective multicenter study is to assess any fracture fixation complication and revision rates during the clinical use of the Proximal Femoral Nail Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.