Back to resultsShort Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
Primary Purpose
Pertrochanteric Hip Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short versus long cephalomedullary Intramedullary nail
Sponsored by
About this trial
This is an interventional treatment trial for Pertrochanteric Hip Fracture
Eligibility Criteria
Inclusion criteria AO/OTA fracture classification 31(A-B) (1-3). Age greater than 18 years old. Exclusion Criteria -Less than 18 years old.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Short nail implant
Long nail implant
Arm Description
used to treat pertrochanteric fractures
used to treat pertrochanteric fractures
Outcomes
Primary Outcome Measures
SF (short form)-36
Secondary Outcome Measures
Harris Hip Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02285127
Brief Title
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
Official Title
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertrochanteric Hip Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short nail implant
Arm Type
Active Comparator
Arm Description
used to treat pertrochanteric fractures
Arm Title
Long nail implant
Arm Type
Active Comparator
Arm Description
used to treat pertrochanteric fractures
Intervention Type
Procedure
Intervention Name(s)
Short versus long cephalomedullary Intramedullary nail
Intervention Description
Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.
Primary Outcome Measure Information:
Title
SF (short form)-36
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Harris Hip Score
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Reoperation
Time Frame
within 1 year
Title
Mortality
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
AO/OTA fracture classification 31(A-B) (1-3).
Age greater than 18 years old.
Exclusion Criteria
-Less than 18 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Sems, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
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