CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 330 enrolled
Drug / intervention
Arthroplasty +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/NCT04075461
NCT04075461N/ACompleted

Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial

University of Southern Denmark·interventional·Posted Aug 30, 2019·Updated Mar 25, 2025

In Brief

A clinical study evaluating Arthroplasty and Internal fixation for Undisplaced Fracture and 3 related conditions. Completed, enrolled 330 participants across 19 sites.

Detailed Summary

This is the world's first national orthopedic randomized controlled trial (RCT) involving 19 out of 21 departments in Denmark. Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. The aim is to compare two surgical treatment methods (metal fixation versus artificial hip) in patients above 65 years with an undisplaced femoral neck fracture. The hypothesis is that even though an artificial hip is a larger surgical procedure than metal fixation of the broken bone, the artificial hip is more stable with less pain due the lack of a healing broken bone and therefore leads to a better and quicker mobilization after surgery. Better mobilization is one of the most important factors for decreasing mortality. We have chosen a pragmatic RCT design by using the local departmental implants. We hope that the knowledge from this study will therefore easily be implemented afterwards.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 30, 2019
Enrollment StartFeb 1, 2020
Primary CompletionJan 26, 2024
Study CompletionJan 26, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.8 years ago

Interventions

Arthroplastyprocedure

Arthroplasty is commonly used for a displaced femoral neck fracture.

Internal fixationprocedure

Internal fixation is commonly used for undisplaced femoral neck fracture