Clinical trial NCT04688593: Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
Official title: Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Hip
Hip Osteoarthritis
Prosthesis Survival
Prosthesis Failure
Keywords: MobileLink
Lead sponsor: Waldemar Link GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
timeFrame: 10-years
Secondary outcomes:
measure: Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 years
measure: Revision rates of the MobileLink acetabular cup system shell(s) with revision for any reason as the endpoint
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 years
measure: Revision rates of the MobileLink acetabular cup system inserts (Ceramic, XLINKed, E-Dur) with revision for any reason as the endpoint
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 years
measure: Revision rates of the combined LINK hip stem(s) with revision for any reason as the endpoint
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 years
measure: Change of baseline hip functionality
timeFrame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Change of baseline hip functionality
timeFrame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Rate of complications and re-operations of the hip joint
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Rate of failed osteointegrated cups
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Rate of failed osteointegrated stems
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Change of postoperative cup position
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Change of postoperative stem position
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Occurence of heterotopic ossifications
timeFrame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
measure: Type and rate of complications with the used instruments related to usability and sterilization
timeFrame: intraoperatively
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
timeFrame: 3 month
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
timeFrame: 1 year
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
timeFrame: 3 year
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
timeFrame: 5 year
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
timeFrame: 7 year
measure: Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
timeFrame: 10 year
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Lubinus Stiftung
city: Kirkcaldy
country: United Kingdom
facility: NHS FIFE Victoria Hospital
Study officials:
References: