Status:
ACTIVE_NOT_RECRUITING
Selecting the Right Hip Prosthesis for Young Patients
Lead Sponsor:
Northern Orthopaedic Division, Denmark
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function d...
Detailed Description
The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an impr...
Eligibility Criteria
Inclusion
- Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.
- Patients who wish to participate in the project and give written consent after oral and written information.
Exclusion
- Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
- Smoking more than 20 cigarettes daily
- Patients with fracture in the femur or acetabulum.
- Patients who do not understand the given patient information
- Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
- Estimated residual life \<10 years
- Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
- Previous surgery on the relevant hip joint.
- Co-Morbidity (ASA Group 3-5).
- Neurological disorder that compromises motor skills and rehabilitation.
- Pregnancy.
- Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
- Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
- Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
- Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).
- Aseptic caput necrosis (posttraumatic, idiopathic).
- Varus or valgus deformity in proximal femur (collum angle \<125 ° or\> 145 °.)
- Collum femoris assessed too retro- or anteverted.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03279276
Start Date
June 1 2018
End Date
December 1 2029
Last Update
April 8 2022
Active Locations (1)
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1
Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital
Farsø, Northern Jutland, Denmark