Total Hip Arthroplasty: The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load.
By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector.
Study 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 development. This is the subject for this study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
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 Criteria:
1. Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
2. Smoking more than 20 cigarettes daily
3. Patients with fracture in the femur or acetabulum.
4. Patients who do not understand the given patient information
5. Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
6. Estimated residual life \<10 years
7. Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
8. Previous surgery on the relevant hip joint.
9. Co-Morbidity (ASA Group 3-5).
10. Neurological disorder that compromises motor skills and rehabilitation.
11. Pregnancy.
12. Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
13. Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
14. Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
15. Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).
16. Aseptic caput necrosis (posttraumatic, idiopathic).
17. Varus or valgus deformity in proximal femur (collum angle \<125 ° or\> 145 °.)
18. Collum femoris assessed too retro- or anteverted.
Primary outcome measure(s)
Bone Mineral Density — 2 -10 years Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
Trial sites (1)
Facility
City
Region
Status
Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital
Farsø
Northern Jutland
More Northern Orthopaedic Division, Denmark trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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