Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures.

Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures: A Prospective Randomized Study of 500 Patients

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).

Study Overview

• Status: Unknown
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Device: Pinloc; Device: Hansson Pins (LIH)

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.

• Study Type: Interventional
• Enrollment (Actual): 537
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Eskilstuna, Sweden, 631 88
    • Department of Orthopedics
  • Falun, Sweden, 791 82
    • Department of Orthopedics
  • Göteborg, Sweden, 413 45
    • Department of Orthopaedics
  • Helsingborg, Sweden, 251 87
    • Department of Orthopedics
  • Motala, Sweden, 591 85
    • Department of Orthopedics, Aleris
  • Norrköping, Sweden, 601 82
    • Department of Orthopedics
  • Nyköping, Sweden, 611 88
    • Department of Orthopedics
  • Uppsala, Sweden, 751 85
    • Department of Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Femoral neck fractures where the preferred treatment is internal fixation.

Exclusion Criteria:

• Unwilling to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pinloc; Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures.	Device: Pinloc; Internal fixation device
Active Comparator: LIH (Hansson pins); 2 pins. An established method for fixation of femoral neck fractures.	Device: Hansson Pins (LIH); Internal fixation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of fracture treatment	Failure is defined as non-union or avascular necrosis.	Within 2 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed-up and go test	Stand up, walk 3 meters, turn around and sit down	At 3 months and 1 year postoperatively
WOMAC (An established hip score)	An established hip score	At 3 months and 1 year postoperatively
Quality of life (EQ-5D)	EQ-5D	At 3 months and 1 year postoperatively
Pain (Visual analogue scale)	Visual analogue scale (VAS): At rest and during activity	At 3 months and 1 year postoperatively

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Torsten Johansson, MD,Ass prof, Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.; Study Director: Torsten Johansson, MD,Ass prof, Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: Pinloc study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes