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ACTIVE NOT RECRUITING
NCT01326832

10 Year Clinical Evaluation of Primoris Hip Component

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

Summary

Using the traditional and hitherto used uncemented hip prostheses achieved good clinical results, but one of the drawbacks is the risk of fracture in the femoral shaft in indbankning of the prosthesis (1-2%). In addition, the bone scan demonstrated that in the years after surgery dropped almost 30% of bone mass in the femoral shaft. This bone loss increases the risk that in the years after surgery, the increased risk of fractures around the prosthesis and in addition to impeding the described bone replacement prosthesis later. The newly developed prosthesis is anchored in the femoral neck and thus not involve the femoral shaft. This ensures a more physiological or normal weight transfer to the femur bone. This contributes to bone mass in long large extent preserved in the years after surgery, so you have a better opportunity later to make a new prosthesis surgery with good results. The new prosthesis should be capable of simultaneously reducing the incidence of thigh pain in the first year after surgery.'

Official title: Prospective Study for Evaluation of Proximally Anchored (Metaphysis) Cementless Femoral Component for Total Hip Arthroplasty. 10 Year Clinical Evaluation,DXA and RSA Follow-up of Primoris® Femoral Component.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2011-09

Completion Date

2024-12

Last Updated

2024-07-01

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Primoris

Total hip arthroplasty with the new Primoris femoral component

Locations (2)

Aalborg University Hospital

Aalborg, Denmark

Veijle Hospital

Vejle, Denmark