Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation
This trial is active, not recruiting.
|Conditions||survival of the implants with revision as endpoint, clinical performance with hhs, patients satisfaction with the hip implant|
|Treatment||uncemented primary total hip arthroplasty|
|Sponsor||University Hospital of North Norway|
|Start date||April 2004|
|End date||March 2023|
|Trial size||400 participants|
|Trial identifier||NCT01118247, 200602701-8/IAY/400, P-REK NORD 44/206|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Survival with revision as endpoint.
time frame: 5-20 years
Clinical outcome with Harris Hip Score.
time frame: 10-30 years
time frame: 10-30years
Patient satisfaction with the hip prosthesis.
time frame: 10-30 years
Male or female participants from 18 years up to 70 years old.
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.
|Official title||Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation|
|Principal investigator||Arvid Småbrekke, MD|
|Description||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 2,01 years, and 288 hips have completed follow ups at an average of 5,14 years.|
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