hip artrosis hip wear
Conditions
Interventions
Cemented total hip prosthesis
Sponsors
Zimmer Biomet
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Candidates for a total hip replacement because of arthritis of the hip. 2. Patients with a good general condition. 3. Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an informed consent. 4. Males and females. 5. Age between 55 and 75. 6. Absence or little presence of osteoporotic bone (t>-2). 7. ASA score 1 and 2.
Exclusion criteria
Exclusion criteria: Severe comorbidities Infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - - Stability measured with RSA at discharge, 3, 6, 12 and 24 months postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety defined as absence of serious device related complications. - Efficacy defined as functional outcome measured with HHS and the HOOS preoperatively, 6 weeks, 3, 6 and 12 months and subsequently annually until 7 years postoperatively and at 10 years postoperatively. - Bone density measured using DEXA preoperative and 6 weeks, 1 and 2 10 years postoperative. - Quality of life measured with the SF12 preoperatively, 6 weeks, 3, 6 and 12 months and subsequently annually until 7 years postoperatively and at 10 years postoperatively.. | — |
Countries
Netherlands
Outcome results
None listed