At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 190 enrolled

Drug / intervention

Trans-gluteal approach, CLAS +1 moreprocedure

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01408693

NCT01408693Phase 4Completed

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Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures - A Prospective Randomized Trial

University Hospital, Basel, Switzerland·interventional·Posted Aug 3, 2011·Updated Oct 25, 2017

In Brief

A Phase 4 clinical trial evaluating Trans-gluteal approach, CLAS and Anterior minimal invasive approach, AMIS for Femoral Neck Fracture. Completed, enrolled 190 participants across 1 site.

Detailed Summary

The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the "Timed up and go"-test (TUG).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFemoral Neck Fracture

CountriesSwitzerland

Collaborators--

Timeline

Phase 4CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2011

First PostedAug 2011

Primary CompletionApr 2015

Study CompletionApr 2016

TodayJul 2026

First PostedAug 3, 2011

Enrollment StartAug 1, 2011

Primary CompletionApr 1, 2015

Study CompletionApr 1, 2016

TodayJul 2, 2026

Enrollment to primary: 3.7 yearsPosted 14.9 years ago

Interventions

Trans-gluteal approach, CLASprocedure

Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Anterior minimal invasive approach, AMISprocedure

Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures