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NCT Number: NCT02254980

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Total Hip Arthroplasty

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic department, Danderyd Hospital

Stockholm, 18288, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin-E diffused polyethylene acetabular component

Device

Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E

Standard polyethylene acetabular component

Device

Patients will undergo total hip arthroplasty using a standard cemented acetabular component

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study 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

Acronym: E1-hip

Important dates

Study start
2013
Primary completion
2019
Study completion
2026
First posted
Oct 2, 2014
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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