Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up

Study Overview
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Brief Summary
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The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results. The MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis systen under routine condition and the determine the satisfaction of the patients.

Official Title
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Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up

Conditions
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Osteoarthritis, Hip, Hip Osteoarthritis, Prosthesis Survival, Prosthesis Failure

Intervention / Treatment
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* Device: MobileLink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link Age ≥ 18 years Fully signed patient informed cons Exclusion Criteria: Revisions Body Mass Index (BMI) ≥ 40 kg/m² Patient who is foreseeable not able to understand the study and the study-related circumstances Patients who is foreseeable non-compliant to the treatment and the follow-ups Pregnant or breast-feeding women Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MobileLink|Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 10-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint |  | 3 months, 1 year, 3, 5, 7 and 10 years | 
| Revision rates of the MobileLink acetabular cup system shell(s) with revision for any reason as the endpoint |  | 3 months, 1 year, 3, 5, 7 and 10 years | 
| Revision rates of the MobileLink acetabular cup system inserts (Ceramic, XLINKed, E-Dur) with revision for any reason as the endpoint |  | 3 months, 1 year, 3, 5, 7 and 10 years | 
| Revision rates of the combined LINK hip stem(s) with revision for any reason as the endpoint |  | 3 months, 1 year, 3, 5, 7 and 10 years | 
| Change of baseline hip functionality | measured by the Harris Hip Score (HHS) (maximum 100 points, minimum 0 points, a higher score indicates a better outcome) | pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Change of baseline hip functionality | measured by the Hip disability and osteoarthritis outcome score (HOOS), (maximum 100 points, minimum 0 points, a higher score indicates a better outcome) | pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Rate of complications and re-operations of the hip joint |  | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Rate of failed osteointegrated cups | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Rate of failed osteointegrated stems | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Change of postoperativ cup position | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Change of postoperativ stem position | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Occurence of heterotopic ossifications | radiological assessment, classified according to Brooker | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | 
| Type and rate of complications with the used instruments related tp usability and sterilization |  | intraoperatively | 
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 3 month | 
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 1 year | 
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 3 year | 
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 5 year | 
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 7 year | 
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | calculated with Kaplan-Meier method. | 10 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MobileLink