RadioStereometric Analysis of the Plus orthopedics SL-MIA stem and the SL-stem, a randomised controlled trial.

Conditions: Coxarthrosis
Osteo-arthritis of the hip
painful worn hipjoint
10023213
10005944

Registration Number: NL-OMON42137

Lead Sponsor: Deventer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

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

• 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The primary endpoint will be implant migration<br /><br>after two years. Migration will be measured by RSA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary endpoints will be bone density alteration measured by DEXA scan,<br /><br>HOOS scores over time, postoperative pain, patient satisfaction, length of<br /><br>hospital stay.</p><br>