A Comparison Between Titanium Femoral Stem and Cobalt-Chr... | NCT00120952

Studies
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty

NCT00120952

Sponsor

University of Aarhus

Status

Withdrawn

Last Update Posted

Dec 27, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

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

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Jan 2010

First Submitted Date

Jul 12, 2005

First Submission Date that Met QC Criteria

Jul 18, 2005

First Posted Date

Jul 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2022

Last Update Posted Date

Dec 27, 2022Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Bi-Metric femoral implant (titanium versus cobalt-chromium)	Device

Measure	Description	Time Frame
Migration of femoral components evaluated by RSA

Measure	Description	Time Frame
Periprosthetic BMD changes evaluated by DEXA

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary osteoarthritis of the hip
Spinal anesthesia
Informed written consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjeld Søballe, MD, DMSc	Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic Department, Ribe County Hospital		Esbjerg		6700	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided