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

January 24, 2024 updated by: Waldemar Link GmbH & Co. KG

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Kiel, Germany
        • Recruiting
        • Lubinus Stiftung
        • Contact:
          • Jörg Löwe
  • United Kingdom
      • Kirkcaldy, United Kingdom
        • Recruiting
        • NHS FIFE Victoria Hospital
        • Contact:
          • Muhammad Adeel Akhtar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
Time Frame: 10-years
calculated with Kaplan-Meier method.
10-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 years
3 months, 1 year, 3, 5, 7 and 10 years
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 years
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
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 years
3 months, 1 year, 3, 5, 7 and 10 years
Change of baseline hip functionality
Time Frame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
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
Change of baseline hip functionality
Time Frame: 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)
pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of complications and re-operations of the hip joint
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated cups
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
radiological assessment
3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated stems
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
radiological assessment
3 months, 1 year, 3, 5, 7 and 10 year follow-up
Occurence of heterotopic ossifications
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
radiological assessment, classified according to Brooker
3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative cup position
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
radiological assessment
3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative stem position
Time Frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
radiological assessment
3 months, 1 year, 3, 5, 7 and 10 year follow-up
Type and rate of complications with the used instruments related to usability and sterilization
Time Frame: intraoperatively
intraoperatively
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time Frame: 3 month
calculated with Kaplan-Meier method.
3 month
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time Frame: 1 year
calculated with Kaplan-Meier method.
1 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time Frame: 3 year
calculated with Kaplan-Meier method.
3 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time Frame: 5 year
calculated with Kaplan-Meier method.
5 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time Frame: 7 year
calculated with Kaplan-Meier method.
7 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time Frame: 10 year
calculated with Kaplan-Meier method.
10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Waldemar Link GmbH & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Estimated)

January 1, 2036

Study Completion (Estimated)

January 1, 2036

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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