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10 Year Clinical Evaluation of Primoris Hip Component

NCT01326832 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2024-07-01

No results posted yet for this study

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.'

Conditions

  • Coxarthrosis

Interventions

DEVICE

Primoris

Total hip arthroplasty with the new Primoris femoral component

Sponsors & Collaborators

  • Biomet Denmark A/S

    collaborator INDUSTRY

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Poul T NIELSEN, PhD · Aalborg University Hospital

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • Denmark

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 NCT01326832 on ClinicalTrials.gov