Longterm-Evaluation of Vitelene® Against Standard

Study Overview
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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.

Official Title
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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)

Conditions
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Osteoarthritis, Hip, Arthritis

Intervention / Treatment
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* Device: Vitelene
* Device: XLPE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitelene<br>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<br>* THA<br>|
| XLPE<br>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<br>* THA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA) | After 1, 5, 10 and 15 years |