Joint Arthroplasty, Taperloc, hip, RSA
Conditions
Interventions
Placement of an uncemented GTS® or uncemented porous coated Taperloc® stem in combination with an uncemented Regenerex and E1 liner.
Sponsors
MC Haaglanden
Reinier de Graaf Groep, Delft
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant females : ≤ 70 years; 2. Patients with a Quetelet index (QI=weight in (kilogram)/ square length (meters)) < 35; 3. Patients requiring primary THR, suitable for the use of the GTS and Taperloc stem; 4. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis; 5. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule; 6. ASA classification score I-III; 7. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
Exclusion criteria
Exclusion criteria: 1. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome is considered unsatisfactory or not good. (Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip Score >85) can be included in the study); 2. Patients who had a THA on contralateral side less than 6 months ago; 3. Patients with a major surgical procedure during the 12 weeks before the study-related operation; 4. Dutch language not mastered; 5. The patient is unwilling to cooperate with the study; 6. The patient is pregnant or desired to be pregnant after surgery or is using inadequate birth control; 7. Recent Myocardial infarct or CVA (<3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stem migration measured with RSA analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcome: 1. Harris Hip Score (HHS); 2. HOOS questionnaire; 3. EQ5-D; 4. Standard radiographic parameters which include qualitative femoral and acetabular findings. | — |
Contacts
Public ContactB.J.W. Thomassen
Haaglanden Medical Center PO Box 432
Outcome results
None listed