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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
Torsten Johansson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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