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

NCT ID: NCT02776631

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pinloc

Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures.

Group Type EXPERIMENTAL

Pinloc

Intervention Type DEVICE

Internal fixation device

LIH (Hansson pins)

2 pins. An established method for fixation of femoral neck fractures.

Group Type ACTIVE_COMPARATOR

Hansson Pins (LIH)

Intervention Type DEVICE

Internal fixation device

Interventions

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Pinloc

Internal fixation device

Intervention Type DEVICE

Hansson Pins (LIH)

Internal fixation device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unwilling to participate.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Department of Orthopedics, Motala

UNKNOWN

Sponsor Role collaborator

Department of Orthopedics, Norrköping

UNKNOWN

Sponsor Role collaborator

Department of Orthopedics, Nykoeping

UNKNOWN

Sponsor Role collaborator

Department of Orthopedics, Eskilstuna

UNKNOWN

Sponsor Role collaborator

Department of Orthopedics, Falun

UNKNOWN

Sponsor Role collaborator

Department of Orthopedics, Uppsala University Hospital

UNKNOWN

Sponsor Role collaborator

Department of Orthopedics, Helsingborg

UNKNOWN

Sponsor Role collaborator

Torsten Johansson

OTHER

Sponsor Role lead

Responsible Party

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Torsten Johansson

MD (Orthopedic surgeon), Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Torsten Johansson, MD,Ass prof

Role: PRINCIPAL_INVESTIGATOR

Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.

Torsten Johansson, MD,Ass prof

Role: STUDY_DIRECTOR

Division of Orthopaedics, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Sweden.

Locations

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Department of Orthopedics

Eskilstuna, , Sweden

Site Status

Department of Orthopedics

Falun, , Sweden

Site Status

Department of Orthopaedics

Gothenburg, , Sweden

Site Status

Department of Orthopedics

Helsingborg, , Sweden

Site Status

Department of Orthopedics, Aleris

Motala, , Sweden

Site Status

Department of Orthopedics

Norrköping, , Sweden

Site Status

Department of Orthopedics

Nyköping, , Sweden

Site Status

Department of Orthopedics

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Pinloc study

Identifier Type: -

Identifier Source: org_study_id

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