joint wear osteoarthrosis
Conditions
Interventions
All patients will receive a total hip prosthesis because of their invalidity
and health problems which will be monitored by model-based RSA analysis. Four
different hip prostheses will be used.
Sponsors
Haaglanden Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis. - Correction of functional deformity. Additional inclusion criteria include: - Male or female - > 18 and
Exclusion criteria
Exclusion criteria: - Any active infection, sepsis or osteomyelitis; standard contraindications for elective surgery - Uncooperative patient or patient with neurologic disorders who are incapable of following directions - Osteoporosis or osteomalacia as assessed during preoperative planning. - Metabolic disorders which may impair bone formation - Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, which cannot be explained by other comorbidity - Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is implant stability (measured with Model-based RSA) at 2 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are implant stability and development (early or late ingrowth) during the pre-defined follow-up periods, standard radiographic parameters which include qualitative femoral and acetabular findings as well as position of the stem and cup, clinical outcomes measured with patient reported outcomes. Other clinical data about the procedure intraoperative/surgical data, survivorship and adverse events will be routinely monitored. | — |
Countries
Netherlands
Outcome results
None listed