Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation

Study Overview
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Brief Summary
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Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening. The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation. Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design. 0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.

Detailed Description
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Investigate survival of the implants and possible biological consequences. Clinical outcome with Harris Hip Score. Radiographic outcome with a modified protocol after JRC, JBJS 1990. Patient satisfaction with the hip prosthesis (five categories). Grit blasted TiAL6V4 + pure Ti versus grit blasted TiAL6V4 + pure Ti +HA, with almost the same roughness. Screw cup, double tapered stem, partly double coated cup, proximally double coated stem. Prospective RCT. Multicenter ( Three hospitals). Selected surgeons. Non-inferiority-design. At present 569 hips (391 patients, 178 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013. 548 hips have completed follow ups at an average of 2 years, 301 hips have completed follow ups at an average of 5 years and 60 hips at 8-10 years.

Official Title
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Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation

Conditions
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Survival of the Implants With Revision as Endpoint, Clinical Performance With HHS, Patients Satisfaction With the Hip Implant

Intervention / Treatment
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* Procedure: Uncemented primary total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary or secondary osteoarthrosis. Both gender, less than seventy years. Patients operated for FCF and patients with previous osteotomies are included. Exclusion Criteria: Treatment with Prednisolon. Osteomyelitis. Serious infections illnesses. Cancer or metastasis. Rheumatoid arthritis. Osteonecrosis after use of alcohol or medicaments. Kidney illnesses. Metabolic bone diseases. Earlier hip arthrodesis. Allergic reactions on implants. Patients who do not cooperate on rehabilitation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pure Ti<br>Cup and stem partly coated with pure titanium | Procedure: Uncemented primary total hip arthroplasty<br>* Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.<br>* Other names: Head, liner: Biotechni, Fr, Morgan, GB;|
| Active Comparator: pure Ti and HA<br>Cup and stem partly coated with pure titanium, and fully coated with HA. | Procedure: Uncemented primary total hip arthroplasty<br>* Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.<br>* Other names: Head, liner: Biotechni, Fr, Morgan, GB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with revision as endpoint. |  | 5-20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome with Harris Hip Score. |  | 10-30 years | 
| Radiographic outcome. | The radiographic evaluation will be carried out postoperatively, 2, 5, 10, 15 and 20 years after the operations with the same protocol modified after Johnston et al, JBJS Am. 1990;72: page 166. We judge and compare a.p pelvic x-rays calibrated on the computer. | 10-30years | 
| Patient satisfaction with the hip prosthesis. | At the consultations we ask the patient if he/she is satisfied with the hip. The patient may answer i 5 categories (dissatisfied, not satisfied, satisfied, very satisfied and very much satisfied). We also have registrations on early and late complications, leg length discrepancy, Trendelenburg lurch etc. | 10-30 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncemented THA, alumina-on-alumina, survival, HHS, Patient satisfaction