NCT02776631

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
537

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4.8 years

First QC Date

January 20, 2016

Last Update Submit

April 16, 2019

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • Failure of fracture treatment

    Failure is defined as non-union or avascular necrosis.

    Within 2 years postoperatively

Secondary Outcomes (4)

  • Timed-up and go test

    At 3 months and 1 year postoperatively

  • WOMAC (An established hip score)

    At 3 months and 1 year postoperatively

  • Quality of life (EQ-5D)

    At 3 months and 1 year postoperatively

  • Pain (Visual analogue scale)

    At 3 months and 1 year postoperatively

Study Arms (2)

Pinloc

EXPERIMENTAL

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

Device: Pinloc

LIH (Hansson pins)

ACTIVE COMPARATOR

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

Device: Hansson Pins (LIH)

Interventions

PinlocDEVICE

Internal fixation device

Pinloc
Hansson Pins (LIH)DEVICE

Internal fixation device

LIH (Hansson pins)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Orthopedics

Eskilstuna, 631 88, Sweden

Location

Department of Orthopedics

Falun, 791 82, Sweden

Location

Department of Orthopaedics

Gothenburg, 413 45, Sweden

Location

Department of Orthopedics

Helsingborg, 251 87, Sweden

Location

Department of Orthopedics, Aleris

Motala, 591 85, Sweden

Location

Department of Orthopedics

Norrköping, 601 82, Sweden

Location

Department of Orthopedics

Nyköping, 611 88, Sweden

Location

Department of Orthopedics

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Torsten Johansson, MD,Ass prof

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

    PRINCIPAL INVESTIGATOR

  • Torsten Johansson, MD,Ass prof

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD (Orthopedic surgeon), Associate professor

Study Record Dates

First Submitted

January 20, 2016

First Posted

May 18, 2016

Study Start

May 1, 2014

Primary Completion

February 1, 2019

Study Completion

December 1, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Locations

SE(8)