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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688593
• Other study ID #: HP15
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Prosthesis Failure
• Prosthesis Survival

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