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 ]
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