10 Year Clinical Evaluation of Primoris Hip Component

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Biomet, Inc.
Sponsor:
Collaborator:
Biomet Denmark A/S
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01326832
First received: March 30, 2011
Last updated: August 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
Coxarthrosis
Device: Primoris

Study Type: Observational
Study Design: 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.

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • RSA [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    radio stereographic analysis for prosthesis migration


Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Primoris
50 patients included in the study
Device: Primoris
Total hip arthroplasty with the new Primoris femoral component
Other Name: Primoris

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

younger patients with coxarthrosis

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326832

Contacts
Contact: Poul T NIELSEN, PhD +45 20946846

Locations
Belgium
CHU Ambroise Pare Recruiting
Mons, Belgium
Contact: Philippe Piriou, Prof. Dr.       philippe.piriou@hap.be   
Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Poul T NIELSEN, PhD    +4520946846      
Contact: Morgens B Laursen, M.D., PhD    +4520946846    mogens.berg.laursen@rn.dk   
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Michael Ulrich-Vinther, Dr         
Veijle Hospital Recruiting
Vejle, Denmark
Contact: Thomas POULSEN, Dr       Thomas.Kristen.Poulsen@rsyd.dk   
Poland
Sokolowski Regional Hospital Not yet recruiting
Szczecin, Poland
Contact: Dariusz Larysz, Dr         
Sponsors and Collaborators
Biomet, Inc.
Biomet Denmark A/S
Investigators
Principal Investigator: Poul T NIELSEN, PhD Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01326832     History of Changes
Other Study ID Numbers: BMETEU.CR.UK4A
Study First Received: March 30, 2011
Last Updated: August 20, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Biomet, Inc.:
THA

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

ClinicalTrials.gov processed this record on September 18, 2014