NCT03000972

Brief Summary

This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

3.8 years

First QC Date

November 10, 2016

Last Update Submit

May 3, 2018

Conditions

Intertrochanteric Fracture

Keywords

AugmentationPET-CTPositron Emission TomographyFluorine-18

Outcome Measures

Primary Outcomes (1)

  • Viability of the femoral head as assessed by fluoride uptake using PET-CT

    The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.

    4 months postoperatively

Secondary Outcomes (4)

  • Viability of the femoral head as assessed by fluoride uptake using PET-CT

    Within 1 week postoperatively

  • Viability of the femoral head as assessed by fluoride uptake using PET-CT

    1 year postoperatively

  • Harris Hip Score

    4 months

  • Harris Hip Score

    1 year

Study Arms (2)

Standard Nail

ACTIVE COMPARATOR

Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).

Procedure: PFN-A Nail

Augmented Nail

EXPERIMENTAL

Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+

Procedure: Cement augmentationProcedure: PFN-A Nail

Interventions

Cement augmentationPROCEDURE
Augmented Nail
PFN-A NailPROCEDURE
Augmented NailStandard Nail

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
  • Healthy contralateral hip
  • ASA (American Society of Anesthesiologists) Physical Status Class I or II

You may not qualify if:

  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 75185, Sweden

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Olof Wolf, MD PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

December 22, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)