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

NCT02288117 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2020-12-19

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Waldemar Link GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Thorsten Gehrke, Prof. Dr. · HELIOS Endo-Klinik Hamburg

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2022-05-31
Completion
2023-05-31

Countries

  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288117 on ClinicalTrials.gov