Clinical Performance With HHS Clinical Trial
Official title:
Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
| Verified date | February 2019 |
| Source | University Hospital of North Norway |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 400 |
| Est. completion date | March 2023 |
| Est. primary completion date | March 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Ortopaedic Department, University Hospital of North Norway | Tromsø |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital of North Norway |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival with revision as endpoint. | 5-20 years | ||
| Secondary | Clinical outcome with Harris Hip Score. | 10-30 years | ||
| Secondary | 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 | |
| Secondary | 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 |