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SPRINT - Randomized Trial of Tibial Fracture Fixation

2014-08-27 03:56:05 | BioPortfolio

Summary

The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

Description

Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Tibial Fracture

Intervention

Intramedullary nail implant

Location

San Francisco General Hospital
San Francisco
California
United States
94110

Status

Completed

Source

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:05-0400

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PubMed Articles [2415 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

The use of nails that are inserted into bone cavities in order to keep fractured bones together.

Excessive lateral nail growth into the nail fold. Because the lateral margin of the nail acts as a foreign body, inflammation and granulation may result. It is caused by improperly fitting shoes and by improper trimming of the nail.

Benign and malignant neoplasms which occur within the substance of the spinal cord (intramedullary neoplasms) or in the space between the dura and spinal cord (intradural extramedullary neoplasms). The majority of intramedullary spinal tumors are primary CNS neoplasms including ASTROCYTOMA; EPENDYMOMA; and LIPOMA. Intramedullary neoplasms are often associated with SYRINGOMYELIA. The most frequent histologic types of intradural-extramedullary tumors are MENINGIOMA and NEUROFIBROMA.

Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)

Separation of nail plate from the underlying nail bed. It can be a sign of skin disease, infection (such as ONYCHOMYCOSIS) or tissue injury.

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