NCT02254980

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2013Oct 2026

Study Start

First participant enrolled

February 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

6.7 years

First QC Date

September 30, 2014

Last Update Submit

February 6, 2019

Conditions

Total Hip Arthroplasty

Keywords

Total hip arthroplastyCemented acetabular cupVitamin-ERadiostereometryFixation of cemented acetabular component in total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Cup migration

    The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.

    2 years

Secondary Outcomes (7)

  • Linear wear

    2 years

  • Linear wear

    4 years

  • Osteolysis

    10 years

  • Osteolysis

    2 years

  • Functional outcome

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Vitamin-E group

EXPERIMENTAL

Vitamin-E diffused polyethylene

Device: Vitamin-E diffused polyethylene acetabular component

Control group

ACTIVE COMPARATOR

Standard polyethylene

Device: Standard polyethylene acetabular component

Interventions

Vitamin-E diffused polyethylene acetabular componentDEVICE

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

Vitamin-E group
Standard polyethylene acetabular componentDEVICE

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

Control group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis of the hip
  • Willingness and ability to follow study-protocol

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Danderyd Hospital

Stockholm, 18288, Sweden

Location

Related Publications (1)

  • Skoldenberg O, Rysinska A, Chammout G, Salemyr M, Muren O, Boden H, Eisler T. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP). BMJ Open. 2016 Jul 7;6(7):e010781. doi: 10.1136/bmjopen-2015-010781.

    PMID: 27388352DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant orthopedic surgeon

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 2, 2014

Study Start

February 1, 2013

Primary Completion

October 1, 2019

Study Completion (Estimated)

October 1, 2026

Last Updated

February 7, 2019

Record last verified: 2019-02

Locations

SE(1)