NCT02391129

Brief Summary

The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 7, 2015

Last Update Submit

March 17, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinical Outcome (Range of Motion of the hip)

    Range of Motion of the hip

    follow up of at least 1 year

  • Radiographic Outcome (boney consolidation of the fracture)

    boney consolidation of the fracture after 3 month, 6 month and at least 1 year after the operation

    follow up of at least 1 year

Secondary Outcomes (1)

  • Patient's Mobility (assessed by the Parker's Mobility Score)

    follow up of at least 1 year

Study Arms (3)

Hyperion Prosthesis

Patients treated with the second generation long-stem revision prosthesis

Procedure: Operation for Periprosthetic fractures of the hip with stem loosening

Helios Prosthesis

Patients treated with the first generation long-stem revision prosthesis

Procedure: Operation for Periprosthetic fractures of the hip with stem loosening

Locking compression plate

Patients treated with LCP

Procedure: Operation for Periprosthetic fractures of the hip with stem loosening

Interventions

Helios ProsthesisHyperion ProsthesisLocking compression plate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We retrospectively reviewed a consecutive series of 102 patients with Vancouver type-B2, B3 and C periprosthetic fractures and unstable femoral stem, which had been prospectively entered, in our hip-trauma database.

You may qualify if:

  • Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.

You may not qualify if:

  • Patients with pathological fractures,
  • Vancouver type-A, Bl, and
  • stable femoral prosthesis stem,
  • Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periprosthetic Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 7, 2015

First Posted

March 18, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03