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NCT02776631 Clinical Trial

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

Femoral Neck Fractures Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02776631
Other study ID # Pinloc study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date December 2019

Study information
Verified date April 2019
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 537
Est. completion date December 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Unwilling to participate.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Pinloc
Internal fixation device
• Hansson Pins (LIH)
Internal fixation device

Locations
Country Name City State
Sweden Department of Orthopedics Eskilstuna
Sweden Department of Orthopedics Falun
Sweden Department of Orthopaedics Göteborg
Sweden Department of Orthopedics Helsingborg
Sweden Department of Orthopedics, Aleris Motala
Sweden Department of Orthopedics Norrköping
Sweden Department of Orthopedics Nyköping
Sweden Department of Orthopedics Uppsala

Sponsors (9)
Lead Sponsor Collaborator
Torsten Johansson Department of Orthopedics, Eskilstuna, Department of Orthopedics, Falun, Department of Orthopedics, Helsingborg, Department of Orthopedics, Motala, Department of Orthopedics, Norrköping, Department of Orthopedics, Nykoeping, Department of Orthopedics, Uppsala University Hospital, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure of fracture treatment Failure is defined as non-union or avascular necrosis. Within 2 years postoperatively
Secondary Timed-up and go test Stand up, walk 3 meters, turn around and sit down At 3 months and 1 year postoperatively
Secondary WOMAC (An established hip score) An established hip score At 3 months and 1 year postoperatively
Secondary Quality of life (EQ-5D) EQ-5D At 3 months and 1 year postoperatively
Secondary Pain (Visual analogue scale) Visual analogue scale (VAS): At rest and during activity At 3 months and 1 year postoperatively
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Withdrawn NCT02198820 - Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome N/A
Active, not recruiting NCT02246335 - Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly N/A
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