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Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

NCT01578408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2020-09-24

No results posted yet for this study

Summary

The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.

Our hypothesis is that an uncemented option spares the patient the operative load of the cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also perhaps reduces the postoperative cognition strain and improves mobilization parameters.

If the uncemented option has the same excellent fixation in poor bone stock, as in the case of these osteopenic fractures, and also has the same good clinical outcome, it would be a viable standard option for the treatment of dislocated femoral neck fractures.

Conditions

  • Femoral Neck Fractures

Interventions

PROCEDURE

Total Hip Arthroplasty

DEVICE

Cemented Lubinus SPII stem (control arm)

Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).

DEVICE

Uncemented HA Coated Corail stem

Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).

Sponsors & Collaborators

  • DePuy Orthopaedics

    collaborator INDUSTRY

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Johan Kärrholm, Prof MD PhD · Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-11
Primary Completion
2018-03-09
Completion
2020-02-19

Countries

  • Sweden

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 NCT01578408 on ClinicalTrials.gov