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Recruiting NCT04688593

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

— Observational Osteoarthritis, Hip Hip Osteoarthritis Prosthesis Survival Prosthesis Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MobileLink.
Who it may be relevant to
Registry conditions: Osteoarthritis, Hip, Hip Osteoarthritis, Prosthesis Survival, Prosthesis Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device MobileLink
    Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.

Primary outcome measures

  • Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, [Time frame: 10-years]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • 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]
  • Change of baseline hip functionality [Time frame: 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]
  • Rate of complications and re-operations of the hip joint [Time frame: 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]
  • Rate of failed osteointegrated stems [Time frame: 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]
  • Change of postoperative stem position [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Germany · 1 center
  • Lubinus Stiftung — Kiel
United Kingdom · 1 center
  • NHS FIFE Victoria Hospital — Kirkcaldy

Identifiers

NCT: NCT04688593 · HP15

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗