NCT00120952

Brief Summary

In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

First QC Date

July 12, 2005

Last Update Submit

December 22, 2022

Conditions

Osteoarthritis

Keywords

RSAOsteoarthritisHip arthroplastyDEXATitaniumCobalt chromiumBone cement

Outcome Measures

Primary Outcomes (1)

  • Migration of femoral components evaluated by RSA

Secondary Outcomes (1)

  • Periprosthetic BMD changes evaluated by DEXA

Interventions

Bi-Metric femoral implant (titanium versus cobalt-chromium)DEVICE

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis of the hip
  • Spinal anesthesia
  • Informed written consent

You may not qualify if:

  • Neuromuscular disease in the affected leg
  • Vascular disease in the affected leg
  • Fracture sequelae in the affected hip
  • Weight over 100 kg
  • Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Department, Ribe County Hospital

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Søballe, MD, DMSc

    Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Completion

January 1, 2010

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations

DK(1)