NCT02288117

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: Waldemar Link GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Hip
• Femur Head Necrosis
• Femoral Neck Fractures

Timeline

• Start date: 2015-07-01
• Primary completion: 2022-05-01
• Completion: 2023-05-01
• First posted: 2014-11-11
• Last updated: 2020-12-19

Locations

4 sites across 3 countries: Germany, Italy, Spain