Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up

Recruiting

• Conditions: Prosthesis Failure; Osteoarthritis, Hip; Prosthesis Survival; Hip Osteoarthritis

• Registration Number: NCT04688593
• Lead Sponsor: Waldemar Link GmbH & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-30
• Study Start: 2021-05-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2036-01
• Study Completion: 2036-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,	10-years	calculated with Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Change of postoperative cup position	3 months, 1 year, 3, 5, 7 and 10 year follow-up	radiological assessment
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
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
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint	10 year	calculated with Kaplan-Meier method.
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
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
Change of baseline hip functionality	pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up	measured by the Hip disability and osteoarthritis outcome score (HOOS), (maximum 100 points, minimum 0 points, a higher score indicates a better outcome)
Rate of complications and re-operations of the hip joint	3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated cups	3 months, 1 year, 3, 5, 7 and 10 year follow-up	radiological assessment
Change of postoperative stem position	3 months, 1 year, 3, 5, 7 and 10 year follow-up	radiological assessment
Occurence of heterotopic ossifications	3 months, 1 year, 3, 5, 7 and 10 year follow-up	radiological assessment, classified according to Brooker
Type and rate of complications with the used instruments related to usability and sterilization	intraoperatively
Rate of failed osteointegrated stems	3 months, 1 year, 3, 5, 7 and 10 year follow-up	radiological assessment

Trial Locations

Locations (2)

Lubinus Stiftung; 🇩🇪 Kiel, Germany

NHS FIFE Victoria Hospital; 🇬🇧 Kirkcaldy, United Kingdom