Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty (E1-hip)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02254980
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Device: Vitamin-E diffused polyethylene acetabular component Device: Standard polyethylene acetabular component Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Standard polyethylene
Device: Standard polyethylene acetabular component
Patients will undergo total hip arthroplasty using a standard cemented acetabular component




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Linear wear [ Time Frame: 2 years ]
    Linear head penetration measured with RSA at 2 years

  2. Linear wear [ Time Frame: 4 years ]
    Linear head penetration measured with RSA at 4 years

  3. Osteolysis [ Time Frame: 10 years ]
    Development of radiolucent lines between bone and cement around the cup.

  4. Osteolysis [ Time Frame: 2 years ]
    Development of radiolucent lines between bone and cement around the cup.

  5. Functional outcome [ Time Frame: 2 years ]
    Hip function measured with Harris hip score

  6. Complication rate [ Time Frame: 10 years ]
    All hip-related complications and revision of implants

  7. Cup migration total [ Time Frame: 2 years ]
    Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
Layout table for location information
Sweden
Orthopaedic department, Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Zimmer Biomet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Olof Skoldenberg, Consultant orthopedic surgeon, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT02254980     History of Changes
Other Study ID Numbers: E1-H
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019

Keywords provided by Olof Skoldenberg, Danderyd Hospital:
Total hip arthroplasty
Cemented acetabular cup
Vitamin-E
Radiostereometry
Fixation of cemented acetabular component in total hip arthroplasty

Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents