Clinical Performance With HHS, Patients Satisfaction With the Hip Implant, Survival of the Implants With Revision as Endpoint
Conditions
Keywords
Uncemented THA, alumina-on-alumina, survival, HHS, Patient satisfaction
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.
Interventions
PROCEDUREUncemented primary total hip arthroplasty
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival with revision as endpoint. | 5-20 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Norway
Outcome results
None listed