Clinical trial NCT02776631: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Neck Fractures
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Department of Orthopedics, Motala
name: Department of Orthopedics, Norrköping
name: Department of Orthopedics, Nykoeping
name: Department of Orthopedics, Eskilstuna
name: Department of Orthopedics, Falun
name: Department of Orthopedics, Uppsala University Hospital
name: Department of Orthopedics, Helsingborg
First posted: 2016-05-18
Enrollment: 537
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unwilling to participate.

Primary outcomes:
measure: Failure of fracture treatment
timeFrame: Within 2 years postoperatively
Secondary outcomes:
measure: Timed-up and go test
timeFrame: At 3 months and 1 year postoperatively
measure: WOMAC (An established hip score)
timeFrame: At 3 months and 1 year postoperatively
measure: Quality of life (EQ-5D)
timeFrame: At 3 months and 1 year postoperatively
measure: Pain (Visual analogue scale)
timeFrame: At 3 months and 1 year postoperatively
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Department of Orthopedics
city: Falun
country: Sweden
facility: Department of Orthopedics
city: Göteborg
country: Sweden
facility: Department of Orthopaedics
city: Helsingborg
country: Sweden
facility: Department of Orthopedics
city: Motala
country: Sweden
facility: Department of Orthopedics, Aleris
city: Norrköping
country: Sweden
facility: Department of Orthopedics
city: Nyköping
country: Sweden
facility: Department of Orthopedics
city: Uppsala
country: Sweden
facility: Department of Orthopedics
Study officials:
affiliation: Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
name: Torsten Johansson, MD,Ass prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.
name: Torsten Johansson, MD,Ass prof
role: STUDY_DIRECTOR
References: