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Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation

NCT01118247 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-02-19

No results posted yet for this study

Summary

Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.

The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation.

Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design.

0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.

Conditions

  • Survival of the Implants With Revision as Endpoint
  • Clinical Performance With HHS
  • Patients Satisfaction With the Hip Implant

Interventions

PROCEDURE

Uncemented primary total hip arthroplasty

Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.

Sponsors & Collaborators

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Olav Reikerås, MD, Prof · Department of Orthopaedics, Rikshospitalet University Clinic, University of Oslo, N-0027 Oslo, Norway.

  • Arvid Småbrekke, MD · University Hospital of North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2023-03-31
Completion
2023-03-31

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 NCT01118247 on ClinicalTrials.gov