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Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

Osteoarthritis, Hip Clinical Trial

Official title:
Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

Clinical Trial Summary

The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions. The results collected will be used to clinically confirm the performance and safety of the LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF. Furthermore the results can be used for future regulatory processes if needed.

Clinical Trial Description

Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions [2,3]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02288117
Study type Observational
Source Waldemar Link GmbH & Co. KG
Contact
Status Active, not recruiting
Phase
Start date July 2015
Completion date May 2023
View Details
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