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NCT Number: NCT04688593

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

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthesis Survival Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lubinus Stiftung, Kiel, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MobileLink

Device

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

Primary outcomes

  1. 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.

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

    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)

  6. 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)

  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

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

    radiological assessment

  9. Rate of failed osteointegrated stems

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

    radiological assessment

  10. Change of postoperative cup position

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

    radiological assessment

  11. Change of postoperative stem position

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

    radiological assessment

  12. Occurence of heterotopic ossifications

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

    radiological assessment, classified according to Brooker

  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

    Time frame: 3 month

    calculated with Kaplan-Meier method.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Skottke, PhD

CONTACT

[email protected]

+494053995673

Sponsors and collaborators

Lead sponsor

Waldemar Link GmbH & Co. KG

Industry

Registry information

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
Dec 30, 2020
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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