10 Year Clinical Evaluation of Primoris Hip Component (Primoris)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01326832
Recruitment Status : Active, not recruiting
First Posted : March 31, 2011
Last Update Posted : September 19, 2017
Biomet Denmark A/S
Information provided by (Responsible Party):
Zimmer Biomet

Brief 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.`

Condition or disease Intervention/treatment
Coxarthrosis Device: Primoris

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : September 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
50 patients included in RSA cohort of total of 350 anticipated Primoris cases
Device: Primoris
Total hip arthroplasty with the new Primoris femoral component

Primary Outcome Measures :
  1. RSA [ Time Frame: 2 years ]
    radio stereographic analysis for prosthesis migration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
younger patients with coxarthrosis

Inclusion Criteria:

  • younger OA patients with good bonestock

Exclusion Criteria:

  1. Patients who do not understand the given information to patients
  2. Competing disorder requiring treatment with anti-inflammatory drugs (NSAIDs, steroids, cytostatics).
  3. Estimated remaining life expectancy < 10 years
  4. Rheumatoid arthritis or other arthritis (eg psoriatic arthritis).
  5. Previous surgery on relevant hip.
  6. Pain Normative and disabling osteoarthritis of the ipsilateral knee.
  7. Co-mobiditet (ASA-group 3-5).
  8. Neurological disorder which compromises the motor skills and rehabilitation courses.
  9. Pregnancy.
  10. Osteoarthritis secondary to Calvé-Legg-Perthes' disease and juvenile epifysiolysis coxae.
  11. Acetabular dysplasia and secondary subluxation (Crowie grade II to IV).
  12. Previously established osteoporosis or osteoporosis detected by current DEXA scan.
  13. Ongoing treatment with osteoporosis medications (calcium and vitamin D, bisphosphonates, estrogen receptor modulating agents and parathyroid hormone, etc.).
  14. Aseptic caputnekrosis (post-traumatic, idiopathic).
  15. Deform the femoral neck (femoral length, measured medially ≤ 15 mm)
  16. Varus or valgus deformity in proximal femur inc. femoral (Collum angel < 125 ° or > 145 °.)
  17. Retroversion or anteversion femur.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01326832

Aalborg University Hospital
Aalborg, Denmark
Veijle Hospital
Vejle, Denmark
Sokolowski Regional Hospital
Szczecin, Poland
Sponsors and Collaborators
Zimmer Biomet
Biomet Denmark A/S
Principal Investigator: Poul T NIELSEN, PhD Aalborg Universitetshospital

Responsible Party: Zimmer Biomet Identifier: NCT01326832     History of Changes
Other Study ID Numbers: BMETEU.CR.UK4A
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases