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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief 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 Summary: 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.
Sponsor: Waldemar Link GmbH & Co. KG

Current Primary Outcome: Stem Survival Rate [ Time Frame: Up to 5 years ]

The survival of the stem


Original Primary Outcome: Stem Survival Rate [ Time Frame: Up to 5 years ]

Current Secondary Outcome:

  • Complication Rate [ Time Frame: Up to 5 years ]
    Number and kind of complications
  • Reoperation Rate [ Time Frame: Up to 5 years ]
    number of reoperations
  • Harris Hip Score (HHS) [ Time Frame: Up to 5 years ]
    Clinical Score to get information about the subjects pain and hip function, collected continuously
  • Oxford Hip Score (OHS) [ Time Frame: Up to 5 years ]
    PROM to assess function and pain after THR
  • Forgotten Joint Score (FJS) [ Time Frame: Up to 2 years ]
    awareness of the artificial joint
  • Mid Thigh Pain [ Time Frame: Up to 5 years ]
    Pain occuring in the front and mid part of the femur


Original Secondary Outcome:

  • Complication Rate [ Time Frame: Up to 5 years ]
  • Reoperation Rate [ Time Frame: Up to 5 years ]
  • Harris Hip Score (HHS) [ Time Frame: Up to 5 years ]
  • Oxford Hip Score (OHS) [ Time Frame: Up to 5 years ]


Information By: Waldemar Link GmbH & Co. KG

Dates:
Date Received: November 6, 2014
Date Started: July 2015
Date Completion: June 2022
Last Updated: April 19, 2017
Last Verified: April 2017