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Undisplaced Femoral Neck Fractures 2 Hansson Pins or 3 Pins Interlocked in Plate (Pinloc) Using RSA

NCT02699619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-05-11

No results posted yet for this study

Summary

Femoral neck fractures represent about half of the hip fractures and are further divided into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always treated surgically with arthroplasty. However there is an ongoing debate on which implant is superior for undisplaced fractures.

A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the original implant consisted of 2 isolated hook pins, the modified design consists of 3 titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of implant design and improves fixation and load transfer amongst the pins. The superiority of the modified design is so far only proven preclinically.

The role of the Pinloc in clinical use remains unclear. Investigators are planning a randomized controlled trial on undisplaced femoral neck fractures to establish a method for implanting the tantalum markers, to observe the fracture healing process and to further investigate the role of the Pinloc.

Conditions

  • Hip Fractures
  • Femoral Neck Fractures

Interventions

DEVICE

Pinloc

3 hook pins interlocked in plate.

DEVICE

2 Hansson pins

2 isolated hook pins.(Without plate)

Sponsors & Collaborators

  • Diakonhjemmet Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Frede Frihagen, PhD · Oslo UH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-04-30
Completion
2021-05-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02699619 on ClinicalTrials.gov