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Polarstem Versus Corail; a Comparison of Micromotion and Periprosthetic Bone Remodelling of Two Femoral Stems

NCT05815953 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-20

No results posted yet for this study

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.

Conditions

  • Arthritis of the Hip

Interventions

DEVICE

Polarstem

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

DEVICE

Corail

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

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    collaborator INDUSTRY

  • Helse-Bergen HF

    lead OTHER

Principal Investigators

  • Geir Hallan, MD; PhD · Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  • Ove N Furnes, MD; PhD · Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  • Torbjørn B Kristensen, MD; PhD · Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  • Jan-Erik Gjertsen, MD; PhD · Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  • Paul J Høl, PhD · Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

  • Irene O Moldestad, MSc · Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2025-01-31
Completion
2033-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815953 on ClinicalTrials.gov