NCT02897440

Brief Summary

A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ \<7, pathological fractures, non-walkers were excluded.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Status
unknown

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

First Submitted

Initial submission to the registry

August 24, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

August 24, 2016

Last Update Submit

September 7, 2016

Conditions

Keywords

Femoral Neck FractureHip ArthroplastyRepairing of soft tissue

Outcome Measures

Primary Outcomes (2)

  • Trendelenburg Test

    30 seconds standing on the operated leg

    At 4 week postoperatively

  • Abductor strength

    Dynamometry

    At 4 week postoperatively

Secondary Outcomes (3)

  • WOMAC

    At 2, 4, 6 weeks and 12 months postoperatively

  • Quality of life (EQ-5D)

    At 2, 4, 6 weeks and 12 months postoperatively

  • Pain (Visual analouge scale)

    At 2, 4, 6 weeks and 12 months postoperatively

Study Arms (2)

Full Repairing of soft tissue surrounding the hip

Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting

Procedure: Full Repairng of soft tissue surrounding the hip

Partial Repairing of soft tissue surrounding the hip

Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting

Procedure: Partial Repairng of soft tissue surrounding the hip

Interventions

Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.

Full Repairing of soft tissue surrounding the hip

Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.

Partial Repairing of soft tissue surrounding the hip

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with femoral neck fractures undergoing hip arthroplasty through anteriorolateral approach.

You may qualify if:

  • Displaced femoral neck fracture
  • Walker
  • Hemiarthroplasty or Total Hip Arthroplasty
  • Preiffer test \>7/10

You may not qualify if:

  • Pathological fracture
  • Non-walker
  • Pfeiffer test \<7/10 indicating mental alteration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 13, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share