Hip Osteoarthritis, Osteoarthritis, Hip, Prosthesis Failure, Prosthesis Survival
Conditions
Keywords
MobileLink
Brief summary
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 system under routine condition and to determine the satisfaction of the patients.
Interventions
DEVICEMobileLink
Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.
Sponsors
Waldemar Link GmbH & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, | 10-years | calculated with Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up | measured by the Harris Hip Score (HHS) (maximum 100 points, minimum 0 points, a higher score indicates a better outcome) |
| 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 | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | radiological assessment |
| 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 | — |
| Change of postoperative cup position | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | radiological assessment |
| Change of postoperative stem position | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | radiological assessment |
| Occurence of heterotopic ossifications | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | radiological assessment, classified according to Brooker |
| Type and rate of complications with the used instruments related to usability and sterilization | intraoperatively | — |
| Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | 3 month | calculated with Kaplan-Meier method. |
| Rate of failed osteointegrated stems | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | radiological assessment |
Countries
Germany, United Kingdom
Contacts
Primary ContactLisa Skottke, PhD
Outcome results
None listed