Total Hip Arthroplasty
Conditions
Brief summary
Post-marketing clinical study,international, multi-centre, prospective, observational. The investigation will be carried out in 2 sites in Europe for a maximum total number of 160 patients.The aim of this study is to assess clinical, radiographic and subjective outcomes after hip arthroplasty with a cementless metaphyseal MINIMA short stem, define the survivorship of the implant and identify possible risk factors that may lead to failure.
Interventions
DEVICEMINIMA stem
Sponsors
Limacorporate S.p.a
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both genders 2. Age ≥ 18 years old 3. Life expectancy over 5 years 4. Any race 5. Ambulatory patients 6. Painful primary coxarthrosis 7. Painful secondary coxarthrosis 8. Avascular necrosis 9. Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits 10. Signed study-specific Informed Consent Form
Exclusion criteria
1. Body mass index over 28 kg/m2 for the modular version 2. Requiring revision of previous standard femoral stem 3. Symptomatic OA of the knees, spine, ankles or contralateral hip, if it can interfere with the evaluation of the target hip according to the Investigator 4. Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS\< 60 points 5. Significant proven or suspicious infection of the target hip 6. Any serious infectious disease before the study according to the Investigator 7. Muscular insufficiency that may compromise functional recovery 8. Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator 9. Known or suspicious hypersensitivity to the metal of the implant 10. Recurrent medical history of immune-mediated reactions or other systemic immune disorders 11. Vascular insufficiency or peripheral neuropathy of lower limbs severe enough to interfere with the study evaluation according to the Investigator 12. Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit 13. Previous organ transplant 14. Any intercurrent chronic disease or condition that may interfere with the completion of the 60-month follow-up, such as liver disease, severe coronary disease, or other clinically significant condition that the Investigator feels may affect the study evaluation 15. Known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition 16. Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study 17. Current alcoholism, and/or any known current addiction to pain medications or drugs 18. Any psychiatric illness that would prevent comprehension of the details and nature of the study 19. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit 20. Unwillingness or inability to comply with rehabilitation and to return for follow-up visits 21. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time up and go test (TUG) | 24 months |
| UCLA activity score | 24 months |
| Range of motion (ROM) | 24 months |
| Harris Hip Score (HHS) | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Revision rate | 24 months |
| Hip disability and Osteoarthritis Outcome Score (HOOS) | 24 months |
| Implant stability measured by radiographic evaluations | 24 months |
| Incidence of device-related Adverse Events/Serious Adverse Events | 24 months |
Other
| Measure | Time frame |
|---|---|
| Mid-term clinical outcomes: Harris Hip Score and Hip disability and Osteoarthritis Outcome Score (HOOS) | 60 months |
| Survival rate (Kaplan Meier) | 60 months |
| Incidence of device-related Adverse Events and Serious Adverse Events | 60 months |
Countries
Italy
Outcome results
None listed