ClinicalTrials.gg
RecruitingNCT04688593Updated Jan 25, 2024

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

An observational study in Osteoarthritis, Hip, Hip Osteoarthritis and Prosthesis Survival, sponsored by Waldemar Link GmbH & Co. KG. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.

Sponsored by Waldemar Link GmbH & Co. KG · Observational

From the registry’s dates

  • Started May 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
520
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • MobileLink
03

In context

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

This study's planned enrollment of 520 is above the median of 135 across 158 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Waldemar Link GmbH & Co. KG is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Revisions
  • (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
520 participants (estimated)
Patient registry
No

Interventions

  • DeviceMobileLink

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

06

What researchers measure

Primary outcomes

  1. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,

    calculated with Kaplan-Meier method.

    Time frame: 10-years

Secondary outcomes

  1. 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

  2. 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. 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

  4. 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

  5. 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)

    Time frame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  6. 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)

    Time frame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  7. Rate of complications and re-operations of the hip joint

    Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  8. Rate of failed osteointegrated cups

    radiological assessment

    Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  9. Rate of failed osteointegrated stems

    radiological assessment

    Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  10. Change of postoperative cup position

    radiological assessment

    Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  11. Change of postoperative stem position

    radiological assessment

    Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  12. Occurence of heterotopic ossifications

    radiological assessment, classified according to Brooker

    Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up

  13. Type and rate of complications with the used instruments related to usability and sterilization

    Time frame: intraoperatively

  14. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint

    calculated with Kaplan-Meier method.

    Time frame: 3 month

  15. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint

    calculated with Kaplan-Meier method.

    Time frame: 1 year

  16. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint

    calculated with Kaplan-Meier method.

    Time frame: 3 year

  17. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint

    calculated with Kaplan-Meier method.

    Time frame: 5 year

  18. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint

    calculated with Kaplan-Meier method.

    Time frame: 7 year

  19. Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint

    calculated with Kaplan-Meier method.

    Time frame: 10 year

07

Study locations

2 of 2 sites recruiting
  • Lubinus Stiftung
    Kiel, Germany
    Recruiting
    • Jörg Löwe · Contact
  • NHS FIFE Victoria Hospital
    Kirkcaldy, United Kingdom
    Recruiting
    • Muhammad Adeel Akhtar · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04688593
Lead sponsor
Waldemar Link GmbH & Co. KG
Responsible party
Sponsor
First posted
Dec 30, 2020
Start date
May 4, 2021
Primary completion
Jan 2036 (estimated)
Completion
Jan 2036 (estimated)
Last update
Jan 25, 2024

Study contacts

Lisa Skottke, PhD
Contact
l.skottke@link-ortho.com
+494053995673

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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