Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWaldemar Link GmbH & Co. KG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
Age ≥ 18 years
Fully signed patient informed cons
Disqualifiers
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
Trial population
primary care clinic
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
MobileLink
DevicePatients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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-yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov