Selecting the Right Hip Prosthesis for Young Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The hip function measured by gait analysis. Hip strength at pressure gauge. Prosthetic migration / migration measured by radio-stereometric analysis (RSA). Patient satisfaction measured by PROMs.

Official Title
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Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primoris<br>Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®. | Procedure: Total Hip Arthroplasty<br>* 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.<br>|
| Active Comparator: Echo<br>Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®. | Procedure: Total Hip Arthroplasty<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans. | 2 -10 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroplasty