M16.1 M16.3 M16.9
Conditions
Interventions
Group 1: Installation of an A2 short stem endoprosthesis with pure plasma spray titanium coating
Group 2: Installation of an A2 short stem endoprosthesis with a plasma spray titanium surface with addi
Sponsors
Fa. ImplanTec Deutschland GmbH
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects requiring primary total hip replacement shall be identified in x-ray primary osteoarthrosis, dysplasia-coxarthrosis or femoral head necrosis unless nuclear magnetic tomographic or native radiological changes in the latter indication extend beyond the areas of the femoral head to be resected and thus involve the femoral neck. 2. Participants are willing to participate in the clinical trial and intend to be available for the intended follow-up. 3. Normal motor function of the lower extremities, documented by clinical examination and absence of history of neurological disease with change in motor function. 4. Participants with age on the day of surgery from 30 to 70 years inclusive. 5. Patient agrees not to participate in any other clinical study for at least 2 years (+3 weeks) according to the index procedure. This includes clinical trials of drugs and invasive procedures. Questionnaire-based studies or other studies that are non-invasive and do not involve drug administration are allowed.
Exclusion criteria
Exclusion criteria: 1. Bony or soft tissue preoperative operation on the affected proximal femur (e.g., varus osteotomy except arthroscopic surgery) 2. Infection of the affected hip joint or systemic infection 3. Known osteoporosis diagnosed by a doctor according to the DVO guidelines. 4. CCD angle over 145° 5. CCD angle below 120° 6. Diseases of the cardiovascular system that result in a significant reduction in everyday stress and are considered a contraindication to exercise (eg ASA score 3 or 4) 7. Proven allergy to components of the implanted prosthesis 8. Known neurological disorders with change in motor function 9. Pregnant or lactating women, those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure. 10. BMI over 30 11. Known alcoholism or other relevant addictions 12. Patients taking or recently participating in other clinical trials. INTRA-OPERATIONAL EXCLUSION CRITERIA 1. Intraoperative fracture of the proximal femur with or without postoperatively required partial loading 2. Intraoperative circumstances leading to a postoperatively required partial loading (complications in the implantation of pans) 3. Intraoperative circumstances requiring the implantation of a prosthesis type other than those intended for the study (as determined by the surgeon). 4. Re-examination: Known osteoporosis diagnosed by a doctor according to the DVO guidelines. PERI-OPERATIONAL EXCLUSION CRITERIA (INSPECTION ON OPERATING DAY) 1. In the RSA X-ray image pairs obscured e.g. the implant will be the bone marker placed in the surrounding femur so that a sufficient number of evaluable tantalum markers can not be identified. The subject is excluded if less than 4 markers are differentiable. 2. The distribution calculated in the first RSA evaluation (so-called conditioning number) of the introduced tantalum markers in the bone is outside the permitted value range, which does not allow further evaluation. The subject is excluded if the Condition Number is greater than 120. SUBSEQUENT EXCLUSION FROM CLINICAL INSPECTION 1. Examiner revokes his consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the determination of the total implant migration after 2 years, which is to be compared with the overall migration of the already established meta-short stem prosthesis as a historical control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are 1.) the determination of the influence of the two different implant coatings and the different implant geometries on the migration behavior and 2.) the clinical-functional results as well as the satisfaction of the participants with the A2-stem. | — |
Countries
Germany
Contacts
Public ContactStefan Budde
Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
Outcome results
None listed