Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures.
Primary Purpose
Femoral Neck Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Pinloc
Hansson Pins (LIH)
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
Eligibility Criteria
Inclusion Criteria:
- Femoral neck fractures where the preferred treatment is internal fixation.
Exclusion Criteria:
- Unwilling to participate.
Sites / Locations
- Department of Orthopedics
- Department of Orthopedics
- Department of Orthopaedics
- Department of Orthopedics
- Department of Orthopedics, Aleris
- Department of Orthopedics
- Department of Orthopedics
- Department of Orthopedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pinloc
LIH (Hansson pins)
Arm Description
Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures.
2 pins. An established method for fixation of femoral neck fractures.
Outcomes
Primary Outcome Measures
Failure of fracture treatment
Failure is defined as non-union or avascular necrosis.
Secondary Outcome Measures
Timed-up and go test
Stand up, walk 3 meters, turn around and sit down
WOMAC (An established hip score)
An established hip score
Quality of life (EQ-5D)
EQ-5D
Pain (Visual analogue scale)
Visual analogue scale (VAS): At rest and during activity
Full Information
NCT ID
NCT02776631
First Posted
January 20, 2016
Last Updated
April 16, 2019
Sponsor
Torsten Johansson
Collaborators
Sahlgrenska University Hospital, Sweden, Department of Orthopedics, Motala, Department of Orthopedics, Norrköping, Department of Orthopedics, Nykoeping, Department of Orthopedics, Eskilstuna, Department of Orthopedics, Falun, Department of Orthopedics, Uppsala University Hospital, Department of Orthopedics, Helsingborg
1. Study Identification
Unique Protocol Identification Number
NCT02776631
Brief Title
Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures.
Official Title
Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures: A Prospective Randomized Study of 500 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Torsten Johansson
Collaborators
Sahlgrenska University Hospital, Sweden, Department of Orthopedics, Motala, Department of Orthopedics, Norrköping, Department of Orthopedics, Nykoeping, Department of Orthopedics, Eskilstuna, Department of Orthopedics, Falun, Department of Orthopedics, Uppsala University Hospital, Department of Orthopedics, Helsingborg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).
Detailed Description
Patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to Pinloc or Hansson Pins using an on-line randomization system.
The patients will be followed up at open visits at 3 months and 1 year. At two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
537 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pinloc
Arm Type
Experimental
Arm Description
Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures.
Arm Title
LIH (Hansson pins)
Arm Type
Active Comparator
Arm Description
2 pins. An established method for fixation of femoral neck fractures.
Intervention Type
Device
Intervention Name(s)
Pinloc
Intervention Description
Internal fixation device
Intervention Type
Device
Intervention Name(s)
Hansson Pins (LIH)
Intervention Description
Internal fixation device
Primary Outcome Measure Information:
Title
Failure of fracture treatment
Description
Failure is defined as non-union or avascular necrosis.
Time Frame
Within 2 years postoperatively
Secondary Outcome Measure Information:
Title
Timed-up and go test
Description
Stand up, walk 3 meters, turn around and sit down
Time Frame
At 3 months and 1 year postoperatively
Title
WOMAC (An established hip score)
Description
An established hip score
Time Frame
At 3 months and 1 year postoperatively
Title
Quality of life (EQ-5D)
Description
EQ-5D
Time Frame
At 3 months and 1 year postoperatively
Title
Pain (Visual analogue scale)
Description
Visual analogue scale (VAS): At rest and during activity
Time Frame
At 3 months and 1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Femoral neck fractures where the preferred treatment is internal fixation.
Exclusion Criteria:
Unwilling to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Johansson, MD,Ass prof
Organizational Affiliation
Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Torsten Johansson, MD,Ass prof
Organizational Affiliation
Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthopedics
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Department of Orthopedics
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Department of Orthopaedics
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Department of Orthopedics
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
Facility Name
Department of Orthopedics, Aleris
City
Motala
ZIP/Postal Code
591 85
Country
Sweden
Facility Name
Department of Orthopedics
City
Norrköping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Department of Orthopedics
City
Nyköping
ZIP/Postal Code
611 88
Country
Sweden
Facility Name
Department of Orthopedics
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures.
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