NCT01713062

Brief Summary

The purpose of this randomised prospective multicenter longterm study is to evaluate the survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip Arthroplasty.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

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 Progress78%
Jan 2012Jun 2030

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

15.3 years

First QC Date

October 15, 2012

Last Update Submit

November 14, 2025

Conditions

Osteoarthritis, HipArthritis

Outcome Measures

Primary Outcomes (1)

  • Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision

    The Oxidation index is measured after explantation in case of loosening of the inlay

    Oxidation index is assessed in case of loosening and revision within 15 years

Secondary Outcomes (3)

  • Manifest radiological osteolyses

    Measured radiologically after 1, 5, 10 and 15 years

  • Traceable wear of polyethylene over 0.5 mm

    Measured radiologically after 1, 5, 10 and 15 years

  • Clinical Outcome

    After 1, 5, 10 and 15 years

Study Arms (2)

Vitelene

Plasmacup DC® with Vitelene® inlay manufactured by UHMWPE-XE (Ultra High Molecular Weight Polyethylene highly cross-linked with 0.1% Vitamin E) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)

Device: Vitelene

XLPE

Plasmacup DC® with a standard polyethylene inlay manufactured by UHMWPE-X (Ultra High Molecular Weight Polyethylene highly cross-linked) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)

Device: XLPE

Interventions

ViteleneDEVICE

THA

Vitelene
XLPEDEVICE

THA

XLPE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients

You may qualify if:

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Indication of cementless THA
  • Approval of study participation and treatment according to study protocol
  • Physical and mental willingness of adhering to clinical and radiological follow up

You may not qualify if:

  • Patient is not able to join follow up
  • Increased risk of anaesthesia according to the "American Society of Anesthesiology": ASA IV
  • Tumor disease
  • Alcohol and drug dependency
  • Permanent cortisone therapy
  • Clinical relevant infections
  • Pregnancy and planned pregnancy
  • Previous interventions like adjustment-osteotomy, treatment of fractures or THA on affected side
  • Acute fractures of the affected hip joint
  • Patients with bone quality, which doesn´t allow a cementless treatment
  • Requirements of clinical relevant deformities (condition after preoperation or bone fracture, leg length discrepancy \> 30 mm, Offset-reduction about \> 30 mm)
  • Small acetabular treatments with 28 mm heads
  • Treatments without using ceramic heads
  • Treatments which require neck prolonging components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef

Bendorf, 56170, Germany

Location

Klinik für Orthopädie und Unfallchirurgie

Bochum, 44791, Germany

Location

Klinik und Poliklinik für Orthopädie

Halle, 06097, Germany

Location

Orthopädische Klinik der MHH im Annastift

Hanover, 30625, Germany

Location

St. Marien Hospital

Mülheim, Germany

Location

Elisabeth Klinikum Olsberg

Olsberg, 59939, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, HipArthritis

Condition Hierarchy (Ancestors)

OsteoarthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Marcus Jäger, Prof. Dr. med

    Universitätsklinikum Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 24, 2012

Study Start

January 1, 2012

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2030

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

DE(6)