Longterm-Evaluation of Vitelene® Against Standard

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Hip Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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®)

Vitelene

Intervention Type DEVICE

THA

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®)

XLPE

Intervention Type DEVICE

THA

Interventions

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Vitelene

THA

Intervention Type DEVICE

XLPE

THA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No