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.
Study Type
OBSERVATIONAL
Enrollment
520
Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.
Lubinus Stiftung
Kiel, Germany
RECRUITINGNHS FIFE Victoria Hospital
Kirkcaldy, United Kingdom
RECRUITINGSurvival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
calculated with Kaplan-Meier method.
Time frame: 10-years
Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated cups
radiological assessment
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated stems
radiological assessment
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative cup position
radiological assessment
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative stem position
radiological assessment
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Occurence of heterotopic ossifications
radiological assessment, classified according to Brooker
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Type and rate of complications with the used instruments related to usability and sterilization
Time frame: intraoperatively
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Time frame: 3 month
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Time frame: 1 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Time frame: 3 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Time frame: 5 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Time frame: 7 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Time frame: 10 year
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