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

NCT04688593 | Recruiting FDA Device

• 1 other identifier: HP15
• Study Type: observational
• Target: 520
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Osteoarthritis, Hip; Hip Osteoarthritis; Prosthesis Survival; Prosthesis Failure

Keywords

MobileLink

Outcome Measures

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.

  10-years

Secondary Outcomes (19)

• Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint

  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

  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

  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

  3 months, 1 year, 3, 5, 7 and 10 years

• Change of baseline hip functionality

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

Interventions

MobileLink DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Waldemar Link GmbH & Co. KG: lead

Study Sites (2)

Lubinus Stiftung

Kiel, Germany

RECRUITING

NHS FIFE Victoria Hospital

Kirkcaldy, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Prosthesis Failure

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa Skottke, PhD

CONTACT

+494053995673; l.skottke@link-ortho.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 30, 2020
• Study Start: May 4, 2021
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

GB (1); DE (1)