Osteoarthritis, rheumatoid arthritis, avascular necrosis
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.
Sponsors
Haaglanden Medical Center, The Hague
Eligibility
Inclusion criteria
Inclusion criteria: - Noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis. - Correction of functional deformity. - > 18 and < 75 years of age - Subjects willing to return for follow-up evaluations. - Subjects able to read and understand Dutch language.
Exclusion criteria
Exclusion criteria: - lnfection - Sepsis - Osteomyelitis - Uncooperative patient or patient with neurologic disorders who are incapable of following directions - Osteoporosis or Osteomalacia - Metabolic disorders which may impair bone formation - Distant foci of infections which may spread to the implant site - Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram - Vascular insufficiency, muscular atrophy or neuromuscular disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is implant stability at 2 years follow-up. Implant stability is measured with measured with Model-based RSA and reported as subsidence, retroversion and maximum total point motion of the prosthesis. | — |
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. | — |
Contacts
Public ContactS. Keizer
Haaglanden Medical Center
Outcome results
None listed