CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 118 enrolled
Drug / intervention
Total hip replacement 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/NCT02085707
NCT02085707N/ACompleted

Complications and Functional Outcome of Displaced Femoral Neck Fractures Treated With Internal Fixation vs Total Hip Arthroplasty in Patients Younger Than 70 Years. A Randomized Controlled Double Blind Multi Center Trial.

University Hospital, Akershus·interventional·Posted Mar 13, 2014·Updated Jan 20, 2021

In Brief

A clinical study evaluating Total hip replacement arthroplasty and Closed reduction and internal fixation for Femoral Neck Fractures and Osteoporosis. Completed, enrolled 118 participants across 4 sites.

Detailed Summary

Patients younger than 70 years with a displaced femoral neck are in serious conditions. The femoral neck fracture is associated with low activity levels, hip pain and substantially reduced quality of life. Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment, and the health economic aspect a great challenge. In this study the investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy femoral neck fractures treated with a total hip arthroplasty leads to a better functional outcome than osteosynthesis, and can patient-related factors be identified that predispose for femoral fracture? It is a randomized multi center study of patients operated with either total hip arthroplasty or osteosynthesis in which functional outcome, complications and reoperations are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that predispose for displaced femoral neck fractures for patients aged 55 - 70 years. Map bone density measured with Dexa for two types of surgical procedures. Map complications and functional outcome after osteosynthesis or total hip replacement in patients aged 55 - 70 years with displaced femoral neck fractures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2014
Enrollment StartJan 1, 2013
Primary CompletionDec 31, 2018
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 12.3 years ago

Interventions

Total hip replacement arthroplastyprocedure

treatment with total hip replacement arthroplasty with the implant chosen by the institution

Closed reduction and internal fixationprocedure

treatment with closed reduction and internal fixation with 2 cannulated hip pins