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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date January 2024
Source Waldemar Link GmbH & Co. KG
Contact Lisa Skottke, PhD
Phone +494053995673
Email l.skottke@link-ortho.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Germany Lubinus Stiftung Kiel
United Kingdom NHS FIFE Victoria Hospital Kirkcaldy

Sponsors (1)

Lead Sponsor Collaborator
Waldemar Link GmbH & Co. KG

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

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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