Coxarthrosis Osteo-arthritis of the hip painful worn hipjoint
Conditions
Interventions
Intervention: after informed consent patients are randomised in one of two
groups. One group receives the currently used traditional SL-Plus stem and the
other group receives the SL-PLUS MIA-stem. E
Sponsors
Deventer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with primary osteoarthritis of the hip with an indication for total hip arthroplasty. • Age 50 to 80 • ASA 1 and 2 • unilateral coxartrhosis • Informed consent of patient • Initial willingness to comply with the post-operative review program
Exclusion criteria
Exclusion criteria: • Ability to comply to the postoperative investigational program • THA or osteosynthesis on the contra lateral hip (not suitable as reference during DEXA-scan) • Expectation that the contra lateral hip also needs a THA within a year • THA because of fracture • Prior surgery on effected hip • Revision arthroplasty • Acute or chronic infections (local or systemic) • Metabolic diseases of the bone • Diseases of the muscular, nervous, or vascular systems that seriously will involve the mobility of the patient after a THA • Femora with structural defects or poor bone quality affecting the stability of the prosthesis • Any concomitant disease which may endanger the implant*s function • Patients with rheumatic, renal, hepatic or gastrointestinal disease and patients using medication that interferes with mineral metabolism (i.e. treatment for osteoporosis or long-term steroid therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The primary endpoint will be implant migration after two years. Migration will be measured by RSA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be bone density alteration measured by DEXA scan, HOOS scores over time, postoperative pain, patient satisfaction, length of hospital stay. | — |
Countries
Netherlands
Outcome results
None listed