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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Torsten Johansson

Current Primary Outcome: Failure of fracture treatment [ Time Frame: Within 2 years postoperatively ]

Failure is defined as non-union or avascular necrosis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: University Hospital, Linkoeping

Dates:
Date Received: January 20, 2016
Date Started: May 2014
Date Completion: August 2018
Last Updated: May 18, 2016
Last Verified: May 2016