At a glance

ClinicalIndex Comparison Record

N/ACompleted· 1,108 enrolled

Drug / intervention

Open reduction internal fixation (ORIF) with single sliding hip screw +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00761813

NCT00761813N/ACompleted

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Fixation Using Alternative Implants for the Treatment of Hip Fractures: A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures

University of Minnesota·interventional·Posted Sep 30, 2008·Updated Jan 5, 2018

In Brief

A clinical study evaluating Open reduction internal fixation (ORIF) with single sliding hip screw and ORIF with multiple cancellous screws for Femoral Neck Fractures. Completed, enrolled 1,108 participants across 32 sites.

Detailed Summary

Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with this injury are expected to soon reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a femoral neck fracture, is often treated with a surgical procedure called internal fixation. When performing internal fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a single large diameter screw with a sliding plate. However, use of the sliding hip screw might in fact result in fewer complications after surgery and reduce the need for a second surgery, called a revision surgery. This study will compare the two different surgical procedures to determine which one results in better outcomes after surgery.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFemoral Neck Fractures

CountriesUnited States

CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Canadian Institutes of Health Research (CIHR), Stichting Nuts Ohra, The Physicians' Services Incorporated Foundation

Timeline

N/ACompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

First PostedSep 2008

Enrollment StartMar 2009

Primary CompletionMar 2016

TodayJul 2026

First PostedSep 30, 2008

Enrollment StartMar 1, 2009

Primary CompletionMar 1, 2016

TodayJul 2, 2026

Enrollment to primary: 7 yearsPosted 17.8 years ago

Interventions

Open reduction internal fixation (ORIF) with single sliding hip screwdevice

The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.

ORIF with multiple cancellous screwsdevice

ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.