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

Sponsor: Waldemar Link GmbH & Co. KG

NCT ID: NCT04688593

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MobileLink (device)
How long the study runs
Study runs about 176 months (dates as stated)
About the drug or intervention
MobileLink — device: Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.
Patient visit burden
Not specified by the sponsor

In plain English

This study follows people who have a hip replacement using the MobileLink cup (the socket part of the hip joint) made by the company Waldemar Link. It looks at how well the hip works and how long the implant lasts over the short, medium and long term. The study is sponsored by the implant maker, Waldemar Link GmbH & Co. KG.

Who can take part

  • Adults aged 18 or over
  • People having a hip replacement with the MobileLink cup and a stem (the part placed in the thigh bone), both made by Waldemar Link
  • People who sign a form to say they agree to take part (informed consent)

Who may not be able to

  • People having revision surgery (a re-do of an earlier hip replacement)
  • People with a Body Mass Index (BMI) of 40 or more
  • People who are not expected to be able to understand the study
  • People who are not expected to follow the treatment or attend follow-up appointments
  • Women who are pregnant or breastfeeding
  • Prisoners

What taking part involves

  • • Surgery to replace the hip using the MobileLink cup (the socket part) and a stem (the part placed in the thigh bone), both made by Waldemar Link
  • • Check-ups after surgery to see how well the hip works and whether the implant lasts

Time commitment: Taking part means having the hip replacement and attending check-ups over the short, medium and long term; the number of visits and total study length are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
520
Started
2021-05-04
Last checked
2024-01

Plain English Summary

What is this study?

  • • Testing a new treatment for osteoarthritis, hip
  • • Clinical study - 520 participants
  • • The implantation of artificial hip joints is one of the most frequently performed surgeries

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with osteoarthritis, hip

Where?

  • • Kirkcaldy - NHS FIFE Victoria Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Osteoarthritis, HipHip OsteoarthritisProsthesis SurvivalProsthesis Failure

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
  • ✓Age ≥ 18 years
  • ✓Fully signed patient informed cons

Who cannot take part

  • ✗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
See the full 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

Where Is This Study? (1 UK site)

NHS FIFE Victoria Hospital

Kirkcaldy, United Kingdom

Recruiting
Hospital R&D contact (matched)

Frances Quirk

fife.fiferesearchapprovals@nhs.scot01383 623623 x 20955

How to Get in Touch

Lisa Skottke, PhD

Sponsor contact

CONTACT

+494053995673 l.skottke@link-ortho.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-01