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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02414542
Other study ID # H-11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date February 2023

Study information

Verified date April 2024
Source Limacorporate S.p.a
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 2023
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MINIMA stem


Locations

Country Name City State
Italy I.R.C.C.S. Galeazzi Milano

Sponsors (1)

Lead Sponsor Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other Mid-term clinical outcomes: Harris Hip Score and Hip disability and Osteoarthritis Outcome Score (HOOS) 60 months
Other Incidence of device-related Adverse Events and Serious Adverse Events 60 months
Other Survival rate (Kaplan Meier) 60 months
Primary Harris Hip Score (HHS) 24 months
Primary UCLA activity score 24 months
Primary Time up and go test (TUG) 24 months
Primary Range of motion (ROM) 24 months
Secondary Hip disability and Osteoarthritis Outcome Score (HOOS) 24 months
Secondary Implant stability measured by radiographic evaluations 24 months
Secondary Revision rate 24 months
Secondary Incidence of device-related Adverse Events/Serious Adverse Events 24 months
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