Osteoarthritis, Hip Clinical Trial
Official title:
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
NCT number | NCT04688593 |
Other study ID # | HP15 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 4, 2021 |
Est. completion date | January 2036 |
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.
Status | Recruiting |
Enrollment | 520 |
Est. completion date | January 2036 |
Est. primary completion date | January 2036 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Lubinus Stiftung | Kiel | |
United Kingdom | NHS FIFE Victoria Hospital | Kirkcaldy |
Lead Sponsor | Collaborator |
---|---|
Waldemar Link GmbH & Co. KG |
Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | Rate of complications and re-operations of the hip joint | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | ||
Secondary | Rate of failed osteointegrated cups | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | |
Secondary | Rate of failed osteointegrated stems | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | |
Secondary | Change of postoperative cup position | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | |
Secondary | Change of postoperative stem position | radiological assessment | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | |
Secondary | Occurence of heterotopic ossifications | radiological assessment, classified according to Brooker | 3 months, 1 year, 3, 5, 7 and 10 year follow-up | |
Secondary | Type and rate of complications with the used instruments related to usability and sterilization | intraoperatively | ||
Secondary | Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | calculated with Kaplan-Meier method. | 3 month | |
Secondary | Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | calculated with Kaplan-Meier method. | 1 year | |
Secondary | Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | calculated with Kaplan-Meier method. | 3 year | |
Secondary | Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | calculated with Kaplan-Meier method. | 5 year | |
Secondary | Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | calculated with Kaplan-Meier method. | 7 year | |
Secondary | Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint | calculated with Kaplan-Meier method. | 10 year |
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