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.
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 Type
OBSERVATIONAL
Enrollment
240
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, Germany
HELIOS ENDO-Klinik
Hamburg, Germany
L'Istituto Ortopedico Gaetano Pini
Milan, Italy
Hospital Sant Rafael
Barcelona, Spain
Stem Survival Rate
The survival of the stem
Time frame: Up to 5 years
Complication Rate
Number and kind of complications
Time frame: Up to 5 years
Reoperation Rate
number of reoperations
Time frame: Up to 5 years
Harris Hip Score (HHS)
Clinical Score to get information about the subjects pain and hip function, collected continuously
Time frame: Up to 5 years
Oxford Hip Score (OHS)
PROM to assess function and pain after THR
Time frame: Up to 5 years
Forgotten Joint Score (FJS)
awareness of the artificial joint
Time frame: Up to 2 years
Mid Thigh Pain
Pain occuring in the front and mid part of the femur
Time frame: Up to 5 years
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