Osteoarthritis, HipVITASNCT01713062
Longterm-Evaluation of Vitelene® Against Standard
An observational study of Osteoarthritis, Hip and Arthritis, run by Aesculap AG at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip, Arthritis
- What is being tested?
- Vitelene and XLPE
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 6 sitesGermany
- Study dates
- Jan 2012to Jun 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
Bendorf, 56170
Klinik für Orthopädie und Unfallchirurgie
Bochum, 44791
Klinik und Poliklinik für Orthopädie
Halle, 06097
Orthopädische Klinik der MHH im Annastift
Hanover, 30625
St. Marien Hospital
Mülheim
Elisabeth Klinikum Olsberg
Olsberg, 59939
About this study
Official 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)
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.
- Conditions
- Osteoarthritis, Hip, Arthritis
- Being tested
- Vitelene, XLPE
- Medical subject headings
- Osteoarthritis, Hip, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViteleneDevice
THA
XLPEDevice
THA
| Study group | Role | What they receive |
|---|---|---|
| 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®) Receives: 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®) Receives: Device: XLPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Oxidation index is assessed in case of loosening and revision within 15 years
Secondary outcomes (3)
Manifest radiological osteolyses
Measured: Measured radiologically after 1, 5, 10 and 15 years
Traceable wear of polyethylene over 0.5 mm
Measured: Measured radiologically after 1, 5, 10 and 15 years
Clinical Outcome
Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)
Measured: After 1, 5, 10 and 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Jäger, Prof. Dr. med, Principal investigator, Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713062
- Sponsor's protocol ID
- AAG-G-H-1113
- Acronym
- VITAS
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2012
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No