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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.
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 improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primoris | Experimental | Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®. |
|
| Echo | Active Comparator | Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans. | 2 -10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis | Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively. | 1 year |
| Radio Stereometric Analysis (RSA) | Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Mogens Laursen, MD, PhD | Northern ODD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital | Farsø | Northern Jutland | Denmark |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Randomized controlled trial
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|
| 2-10 years |
| European Quality of life in 5 Dimensions (EQ5D) | This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation. | 2-10 years |
| Harris Hip Score (HHS) | This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation. | 2-10 years |
| Oxford Hip Score (OHS), | This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation. | 2-10 years |
| University of California Los Angeles Activity Score (UCLA) | This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation. | 2-10 years |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation. | 2-10 years |
| Forgotten Joint Score (FJS) | This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation. | 2-10 years |
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |