10 Year Clinical Evaluation of Primoris Hip Component
This study is currently recruiting participants.
Verified May 2013 by Biomet, Inc.
Sponsor:
Biomet, Inc.
Collaborator:
Biomet Denmark A/S
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01326832
First received: March 30, 2011
Last updated: May 14, 2013
Last verified: May 2013
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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:
- Patients who do not understand the given information to patients
- Competing disorder requiring treatment with anti-inflammatory drugs (NSAIDs, steroids, cytostatics).
- Estimated remaining life expectancy < 10 years
- Rheumatoid arthritis or other arthritis (eg psoriatic arthritis).
- Previous surgery on relevant hip.
- Pain Normative and disabling osteoarthritis of the ipsilateral knee.
- Co-mobiditet (ASA-group 3-5).
- Neurological disorder which compromises the motor skills and rehabilitation courses.
- Pregnancy.
- Osteoarthritis secondary to Calvé-Legg-Perthes' disease and juvenile epifysiolysis coxae.
- Acetabular dysplasia and secondary subluxation (Crowie grade II to IV).
- Previously established osteoporosis or osteoporosis detected by current DEXA scan.
- Ongoing treatment with osteoporosis medications (calcium and vitamin D, bisphosphonates, estrogen receptor modulating agents and parathyroid hormone, etc.).
- Aseptic caputnekrosis (post-traumatic, idiopathic).
- Deform the femoral neck (femoral length, measured medially ≤ 15 mm)
- Varus or valgus deformity in proximal femur inc. femoral (Collum angel < 125 ° or > 145 °.)
- Retroversion or anteversion femur.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326832
Contacts
| Contact: Poul T NIELSEN, PhD | +45 20946846 |
Locations
| 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 | |
| Aarhus University Hospital | Not yet recruiting |
| Aarhus, Denmark | |
| Contact: Michael Ulrich-Vinther, Dr | |
| Hamlet Private Hospital | Not yet recruiting |
| Frederiksberg, Denmark | |
| Contact: Kim SPERLING, Dr | |
| Veijle Hospital | Not yet recruiting |
| Vejle, Denmark | |
| Contact: Thomas POULSEN, Dr | |
| Poland | |
| Sokolowski Regional Hospital | Not yet recruiting |
| Szczecin, Poland | |
| Contact: Dariusz Larysz, Dr | |
| United Kingdom | |
| Royal Derbyshire Hospital | Not yet recruiting |
| Derby, United Kingdom | |
| Contact: Arthur Stephen, 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: | ON-Primoris-MBL |
| Study First Received: | March 30, 2011 |
| Last Updated: | May 14, 2013 |
| 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 June 17, 2013