Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation
- Conditions
- Clinical Performance With HHSSurvival of the Implants With Revision as EndpointPatients Satisfaction With the Hip Implant
- Interventions
- Procedure: Uncemented primary total hip arthroplasty
- Registration Number
- NCT01118247
- Lead Sponsor
- University Hospital of North Norway
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Primary or secondary osteoarthrosis.
- Both gender, less than seventy years.
- Patients operated for FCF and patients with previous osteotomies are included.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pure Ti Uncemented primary total hip arthroplasty Cup and stem partly coated with pure titanium pure Ti and HA Uncemented primary total hip arthroplasty Cup and stem partly coated with pure titanium, and fully coated with HA.
- Primary Outcome Measures
Name Time Method Survival with revision as endpoint. 5-20 years
- Secondary Outcome Measures
Name Time Method Clinical outcome with Harris Hip Score. 10-30 years Radiographic outcome. 10-30years 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.
Patient satisfaction with the hip prosthesis. 10-30 years 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.
Trial Locations
- Locations (1)
Ortopaedic Department, University Hospital of North Norway
🇳🇴Tromsø, Norway