Prospective Clinical 5-year Follow-up of the LINK® Endo-Model® SL®

Active, not recruiting

• Conditions: Failure of Prosthetic Joint Implant; Arthritis/Arthrosis; Bone Necrosis

• Registration Number: NCT02367417
• Lead Sponsor: Waldemar Link GmbH & Co. KG

Brief Summary

The objective of this study is to collect outcome information on patients requiring Total Knee Replacement (TKR) in primary or revision cases and therefore receiving the LINK® Endo-Model® SL® under routine conditions.

Detailed Description

Post Market Clinical Follow-ups (PMCF) through observational investigations are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine condition. Against this background a prospective multi-center study with the LINK® Endo-Model® SL® will be conducted.

Study Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-20
• Study Start: 2017-08-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KOOS	1 yr, 3 yrs and 5 yrs	Knee Injury and Osteoarthritis Outcome Score

Secondary Outcome Measures

Name	Time	Method
KSS	at 3 months, 1 year and 5 years	Knee Society Score to assess knee pain and functional knee capacity
Prosthetic Survival Rate	up to 5 years	Survival of the Prosthesis
Complications	At each Follow-up, up to 5 years	Rate of implant related, surgery related and systemic complications
Rate of subsequent surgical interventions	At each Follow-up, up to 5 years	Different surgical interventions

Trial Locations

Locations (3)

Evangelisches Waldkrankenhaus Spandau; 🇩🇪 Berlin, Germany

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Sachsen, Germany

Medizinische Fakultät Orthopädische Universitätsklinik (KORT); 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany