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Radius Fractures clinical trials

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NCT ID: NCT00587795 Completed - Radius Fractures Clinical Trials

Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

Start date: April 2006
Phase: N/A
Study type: Interventional

Objectives: - To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases: 1. Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures; 2. To obtain comparative data between traditional therapies (sugar tong, plaster backslab, long arm or short arm cast) and the use of the StabilAir brace for each patient qualified by specific criteria. This will provide a complete cost-of-care analysis from one modality to the other. Hypothesis: 1) For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong splint in the acute setting. 2) In cases where full forearm immobilization is initially preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need for full immobilization has passed. The benefit of utilizing a product of this type in the acute or follow-up setting is that it is an adjustable fit, "off-the-shelf" device, which can be quickly and comfortably applied to the patient. It can then transition effectively to be the product of choice for the remainder of treatment through rehabilitation since it will protect, stabilize, and support the injury while adapting to changing patient conditions and needs. Because it is removable (late but not early in fracture core period) there are potential benefits to comfort and hygiene. Therefore, the total cost of care is reduced by using one product from the progress of the injury to fracture reduction and through to recovery (rather than a variety of products that require investment in materials, time, and personnel for cast changes and potential fracture re-reduction. In the initial treatment period, the StabilAir Brace will be firmly held in place by a peripheral "guard wrap" and will only be removed under the supervision of the treating surgeon. Only when clear evidence of fracture healing is present would the patient be allowed to physically remove the brace.

NCT ID: NCT00524719 Completed - Clinical trials for Distal Radius Fractures

Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures

DRF
Start date: January 2007
Phase: N/A
Study type: Interventional

Distal radius fractures are the most common fracture to occur in the adult population, and those which are displaced but maintain joint congruity are the most common subtype. Locking-plate technology represents a true advance in the fixation of these fractures, especially in view of the ever increasing incidence of these injuries in an ageing and osteoporotic population throughout Europe and North America. These plates permit rigid fixation, even in osteopenic bone, while avoiding any tethering of soft tissues, as seen with external fixation and percutaneous pinning. For these reasons, this mode of fracture fixation has rapidly gained popularity. Unfortunately, there is presently little evidence to support their use over the more traditional methods of fixation (percutaneous pinning, external fixation). In addition, the technique for their application is more invasive and their cost is considerably greater than these latter two techniques. As such, it is pertinent to evaluate, in a scientifically sound fashion, the outcome of fixation with the three types of implant included in this study. The results of this clinical trial will allow the orthopaedic community to confidently recommend the fixation method which provides the optimal functional, clinical, and radiographic outcome for a patient suffering a displaced distal radius with preserved joint congruity. Null hypothesis: There is no difference in the functional, clinical, and radiographic outcomes of the three treatment methods. Hypothesis: Given the locking nature of modern screw-plate constructs, which produce excellent fixation even in osteopenic bone and permit early range of motion exercises; and given that plate fixation, in contrast to external fixation and percutaneous pinning, does not tether muscle, tendon, or capsule; plate fixation with a volar fixed-angle device should permit earlier and more aggressive rehabilitation and more rapid and complete regain of hand and wrist function when compared to stabilization with external fixation or percutaneous pinning.

NCT ID: NCT00438750 Completed - Clinical trials for Distal Radius Fractures

Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures

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

The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

NCT ID: NCT00438308 Completed - Clinical trials for Distal Radius Fractures

Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures

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

The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

NCT ID: NCT00274378 Completed - Radius Fractures Clinical Trials

Allomatrix Injectable Putty in Distal Radius Fractures

Start date: June 2005
Phase: Phase 4
Study type: Interventional

Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium sulfate hemihydrate and carboxymethylcellulose. Allomatrix combines the osteoinductive capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium sulfate. Unstable fractures of the distal radius do not resist displacement once it has been manipulated into an anatomical position. There is a parallel between the quality of the anatomic result and the residual capacity of the wrist, except in older, low demanding patients. Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and may provide a better stability around hardware in osteoporotic bone and help maintain reduction of fracture fragments.Moreover, a product like ALLOMATRIX could accelerate and improve bone healing and fracture stability by its osteoinductive properties. However, the clinical significance of these new bone graft materials still have to be proven in a randomised controlled study set-up.

NCT ID: NCT00190944 Completed - Colles' Fracture Clinical Trials

Effects of Teriparatide on Distal Radius Fracture Healing

Start date: December 2004
Phase: Phase 2
Study type: Interventional

Effects of Teriparatide on Distal Radius Fracture Healing

NCT ID: NCT00161629 Completed - Radius Fractures Clinical Trials

Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

Start date: September 2005
Phase: Phase 1
Study type: Interventional

To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

NCT ID: NCT00160810 Completed - Clinical trials for Distal Radius Fractures

Outcome Study of Complex Distal Radius Fractures

Start date: April 2001
Phase: Phase 4
Study type: Observational

The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.