Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT02237482 |
Date of registration:
|
04/09/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery
|
Scientific title:
|
Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery? |
Date of first enrolment:
|
July 2006 |
Target sample size:
|
100 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT02237482 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Sweden
| | | | | | | |
Contacts
|
Name:
|
Johan Kärrholm, Professor |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Sahlgrenska University Hospital, Sweden |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
All patients with a loose acetabular component, undergoing revision
Exclusion Criteria:
Patient not able to understand the intention of the study
Age minimum:
N/A
Age maximum:
85 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Prosthesis Loosening
|
Intervention(s)
|
Device: ZCA cup
|
Device: Trabecular metal cup (TM)
|
Device: Trilogy cup
|
Primary Outcome(s)
|
Proximal migration measured with RSA
[Time Frame: 24 month postoperatively.]
|
Secondary Outcome(s)
|
Patient reported outcome measures
[Time Frame: first two years postoperatively]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|