Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

— E1-hip  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02254980
• Other study ID #: E1-H
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: October 2026

Study information

• Verified date: February 2019
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: October 2026
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Primary osteoarthritis of the hip

• Willingness and ability to follow study-protocol

Exclusion Criteria:

• Inflammatory arthritis or secondary osteoarthritis.

• Type C (stove pipe) femur

• Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components

• Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery

• Ongoing oestrogen treatment

• Not suited for the study for other reason (surgeons preference)

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Device:
• Vitamin-E diffused polyethylene acetabular component
Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
• Standard polyethylene acetabular component
Patients will undergo total hip arthroplasty using a standard cemented acetabular component

Locations

Country	Name	City	State
Sweden	Orthopaedic department, Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Zimmer Biomet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cup migration	The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.	2 years
Secondary	Linear wear	Linear head penetration measured with RSA at 2 years	2 years
Secondary	Linear wear	Linear head penetration measured with RSA at 4 years	4 years
Secondary	Osteolysis	Development of radiolucent lines between bone and cement around the cup.	10 years
Secondary	Osteolysis	Development of radiolucent lines between bone and cement around the cup.	2 years
Secondary	Functional outcome	Hip function measured with Harris hip score	2 years
Secondary	Complication rate	All hip-related complications and revision of implants	10 years
Secondary	Cup migration total	Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).	2 years