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Active, Not Recruiting

NCT Number: NCT01713062

Longterm-Evaluation of Vitelene® Against Standard

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef, Bendorf, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

  • 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

Exclusion:

  • 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

Treatment and study plan

Vitelene

Device

THA

XLPE

Device

THA

Primary outcomes

  1. Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision

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

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

Secondary outcomes

  1. Manifest radiological osteolyses

    Time frame: Measured radiologically after 1, 5, 10 and 15 years

  2. Traceable wear of polyethylene over 0.5 mm

    Time frame: Measured radiologically after 1, 5, 10 and 15 years

  3. Clinical Outcome

    Time frame: After 1, 5, 10 and 15 years

    Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Randomised Prospective Multicenter Longterm-Evaluation of 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)

Acronym: VITAS

Important dates

Study start
2012
Primary completion
2027
Study completion
2030
First posted
Oct 24, 2012
Registry last updated
Nov 17, 2025

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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