Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty (E1-hip)
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|ClinicalTrials.gov Identifier: NCT02254980|
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Arthroplasty||Device: Vitamin-E diffused polyethylene acetabular component Device: Standard polyethylene acetabular component||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2026|
Experimental: Vitamin-E group
Vitamin-E diffused polyethylene
Device: Vitamin-E diffused polyethylene acetabular component
Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
Active Comparator: Control group
Device: Standard polyethylene acetabular component
Patients will undergo total hip arthroplasty using a standard cemented acetabular component
- Cup migration [ Time Frame: 2 years ]The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
- Linear wear [ Time Frame: 2 years ]Linear head penetration measured with RSA at 2 years
- Linear wear [ Time Frame: 4 years ]Linear head penetration measured with RSA at 4 years
- Osteolysis [ Time Frame: 10 years ]Development of radiolucent lines between bone and cement around the cup.
- Osteolysis [ Time Frame: 2 years ]Development of radiolucent lines between bone and cement around the cup.
- Functional outcome [ Time Frame: 2 years ]Hip function measured with Harris hip score
- Complication rate [ Time Frame: 10 years ]All hip-related complications and revision of implants
- Cup migration total [ Time Frame: 2 years ]Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254980
|Orthopaedic department, Danderyd Hospital|
|Stockholm, Sweden, 18288|