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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02776631
Enrollment
537
Registered
2016-05-18
Start date
2014-05-31
Completion date
2019-12-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures

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.

Interventions

DEVICEPinloc

Internal fixation device

DEVICEHansson Pins (LIH)

Internal fixation device

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Department of Orthopedics, Motala
CollaboratorUNKNOWN
Department of Orthopedics, Norrköping
CollaboratorUNKNOWN
Department of Orthopedics, Nykoeping
CollaboratorUNKNOWN
Department of Orthopedics, Eskilstuna
CollaboratorUNKNOWN
Department of Orthopedics, Falun
CollaboratorUNKNOWN
Department of Orthopedics, Uppsala University Hospital
CollaboratorUNKNOWN
Department of Orthopedics, Helsingborg
CollaboratorUNKNOWN
Torsten Johansson
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Unwilling to participate.

Design outcomes

Primary

MeasureTime frameDescription
Failure of fracture treatmentWithin 2 years postoperativelyFailure is defined as non-union or avascular necrosis.

Secondary

MeasureTime frameDescription
Timed-up and go testAt 3 months and 1 year postoperativelyStand up, walk 3 meters, turn around and sit down
WOMAC (An established hip score)At 3 months and 1 year postoperativelyAn established hip score
Quality of life (EQ-5D)At 3 months and 1 year postoperativelyEQ-5D
Pain (Visual analogue scale)At 3 months and 1 year postoperativelyVisual analogue scale (VAS): At rest and during activity

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026