CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 60 enrolled
Drug / intervention
Polarstem +1 moredevice
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/NCT05815953
NCT05815953N/AActive

The Polarstem Versus Corail; a Comparison of Micromotion and Periprosthetic Bone Remodelling of Two Femoral Stems. A Randomised Trial of 60 Patients Using Radiostereometric Analysis, Dual Energy X-ray Absorptiometry and Computer Tomography

Helse-Bergen HF·interventional·Posted Apr 18, 2023·Updated Jan 20, 2025

In Brief

A clinical study evaluating Polarstem and Corail for Arthritis of the Hip. Active but no longer recruiting, targeting 60 participants across 1 site.

Detailed Summary

A randomised controlled trial comparing a recently introduced femoral stem with an established stem for total hip arthroplasty (THA). 60 patients will be randomised into one of the two groups 1. Polarstem uncemented femoral stem (Smith \& Nephew) 2. Corail uncemented femoral stem (De Puy) All patients will receive a 32mm cobalt-chromium (CoCr) femoral head and an R3 acetabular cup with a 10 Mrad highly cross-linked polyethylene (XLPE) liner (Smith \& Nephew). Radiostereometric analysis (RSA) will be used to measure stem migration. Dual-energy x-ray absorptiometry (DXA) measurements will be used to measure bone mineral density. Clinical outcome will be assessed at different time point to evaluate satisfaction and function. Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.

Study Details

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

Timeline

N/AActive
2018201920202021202220232024202520262027202820292030203120322033
First PostedApr 18, 2023
Enrollment StartJun 20, 2017
Primary CompletionJan 31, 2025
Study CompletionJan 31, 2033
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 3.2 years ago

Interventions

Polarstemdevice

Stem used in total hip replacement. Manufacturer: Smith \& Nephew Orthopaedics AG, Baar, Switzerland.

Coraildevice

Stem used in total hip replacement. Manufacturer: De Puy Int Ltd, Leeds, UK.