Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2018-06-01
2029-12-31
Brief Summary
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Detailed Description
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The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning.
The secondary outcomes are to assess:
1. The hip function measured by gait analysis.
2. Hip strength at pressure gauge.
3. Prosthetic migration / migration measured by radio-stereometric analysis (RSA).
4. Patient satisfaction measured by PROMs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Primoris
Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.
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.
Echo
Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Patients who wish to participate in the project and give written consent after oral and written information.
Exclusion Criteria
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.
18 Years
55 Years
ALL
No
Sponsors
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Northern Orthopaedic Division, Denmark
OTHER
Responsible Party
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Principal Investigators
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Mogens Laursen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Northern ODD
Locations
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Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital
Farsø, Northern Jutland, Denmark
Countries
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Other Identifiers
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N-20170030
Identifier Type: -
Identifier Source: org_study_id
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