NCT00526539

Brief Summary

Total hip replacement is a very cost effective procedure to enhance life quality in a group of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions (1). Historically, many different principles have been used from the first resurfacings to cemented and uncemented total hip replacements as we know them today. In 2000, 28 different femoral stems and 26 different acetabular components were in regular use in Norway. There are several well-documented cemented acetabular components, but no such uncemented cup. On the femoral side there are several well-documented stems both cemented and uncemented. (2). From the late 1990's a reverse hybrid (uncemented stem and cemented cup) is being more frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is increasing. (1). This technique is solely based on experience and the fact that one combines the better of two principles (cemented and uncemented). There is no scientific evidence that this technique is as good or better than a cemented THR. One of the potential problems with hydroxyapatite coated components is that it is suspected that it may increase wear due to the particle theory. (3,4). There are no prospective randomised controlled RSA and DXA studies that conclude on this matter. This is such a study and our hypothesis is that there is no difference in wear or osteolysis between the methods.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
Last Updated

July 6, 2011

Status Verified

September 1, 2007

First QC Date

September 6, 2007

Last Update Submit

July 3, 2011

Conditions

Keywords

THRreversed hybridwear

Interventions

Eligibility Criteria

AgeUp to 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis
  • Indication for THR

You may not qualify if:

  • Significant anatomical abnormalities
  • Rheumatoid artheritis, dysplasia, fracture sequela

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Lars Nordsletten, professor, MD, Ph.D

    Ullevål University Hospital, N-0407 Oslo

    STUDY CHAIR
  • Einar Lindalen, MD

    Lovisenberg Hospital, N- 0440 Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Last Updated

July 6, 2011

Record last verified: 2007-09