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Completed

NCT Number: NCT00534326

Standard Reaming Versus Reaming/Irrigating/Aspirating for Intramedullary Nailing of Femoral Shaft Fractures

Reaming (enlarging of the bone canal) is commonly performed prior to the insertion of intramedullary nails for the fixation of long bone fractures. This study is designed to compare the union rates between fractures reamed by standard reaming versus reaming with a Reamer/Irrigator/ Aspirator (RIA). In addition, this study will collect patient-based outcomes on these patients. Little information exists on the patient based outcomes following femur fractures. We hope that the patient based outcomes of this study will also be able to aid physicians in advising patients with femur fractures of their possible outcomes.

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Key information

Conditions

Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women between the ages of 18 years and 85 years;
  • Acute fractures of the femoral shaft

Exclusion criteria

  • Fractures not amenable to intramedullary nailing and deemed by the treating surgeon;
  • Pathological fractures;
  • Open fractures;
  • Patients with additional injuries to the ipsilateral femur;
  • Surgical delay of greater than 7 days from the time of injury;
  • Retained hardware in the affected limb;
  • Previous infection in fractured limb;
  • Likely problems in the judgment of the investigators with maintaining follow-up;
  • Patients with severe cognitive injuries or disabilities will be excluded if it is deemed that they will be unable to complete the study questionnaires;
  • Hopeless diagnosis;
  • Medical comorbidities that prohibit the conductance of surgical treatment under a general anesthetic;
  • Fractures requiring cephalomedullary nails

Treatment and study plan

Standard Reaming

Procedure

Femoral reaming using standard reaming techniques of multiple reamers

Reaming/Irrigating/Aspirating

Procedure

Reaming using the Reamer/Irrigator/Aspirating

Primary outcomes

  1. Fracture Healing

    Time frame: 3 months, 6 months, 1 year, 2 years

Secondary outcomes

  1. Patient Based Quality of Life

    Time frame: Baseline, 3 months, 6 months, 1 year, 2 years

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • University of Missouri-Columbia

Registry information

Acronym: STAFF

Important dates

Study start
2006
Primary completion
2015
Study completion
2018
First posted
Sep 24, 2007
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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