Actively Recruiting
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
Led by Waldemar Link GmbH & Co. KG · Updated on 2024-01-25
520
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the MobileLink hip prosthesis system, a medical device approved for safety and performance, in patients undergoing hip joint replacement surgery due to osteoarthritis. The study aims to collect clinical data on the outcomes and patient satisfaction with this device over short, mid, and long-term follow-up periods. Participants who receive the MobileLink hip prosthesis system will be followed for up to 10 years. The study monitors the survival rate of the complete prosthesis system and tracks revisions for any reason at multiple time points, including 3 months, 1 year, and up to 10 years post-implantation. The study also observes revision rates for different components, hip functionality changes, complication rates, implant positioning, and other related outcomes. During the study, participants will undergo regular follow-up visits at 3 months, 1 year, and then at 3, 5, 7, and 10 years after surgery. These visits include assessments of hip function, imaging to check implant position, and monitoring for complications or need for revision surgery. Researchers will measure the device's survival, patient satisfaction, and any issues with the hip joint or prosthesis components throughout the study duration.
CONDITIONS
Brief Title
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
- Age 18 years or older
- Fully signed patient informed consent
You will not qualify if you...
- Revision surgeries
- Body Mass Index (BMI) of 40 kg/m² or higher
- Patients unable to understand the study or study-related circumstances
- Patients likely to be non-compliant with treatment and follow-ups
- Pregnant or breastfeeding women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 1 week
Participants undergo implantation of the MobileLink acetabular cup system and femoral stem, followed by immediate post-operative care.
1 visit (in-person) on the day of surgery
Duration - Up to 10 years
Participants are monitored through scheduled follow-ups to assess the hip functionality, prosthesis survival, and any complications over time.
Follow-up visits at 3 months, 1 year, 3 years, 5 years, 7 years, and 10 years
Trial Site Locations
Total: 2 locations
1
Lubinus Stiftung
Kiel, Germany
Actively Recruiting
2
NHS FIFE Victoria Hospital
Kirkcaldy, United Kingdom
Actively Recruiting
Research Team
L
Lisa Skottke, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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