Minima Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre, Prospective, Observational Clinical Study Evaluating the Outcomes of a Cementless Metaphyseal Short Stem After Hip Arthroplasty

Conditions
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Total Hip Arthroplasty

Intervention / Treatment
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* Device: MINIMA stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders Age ≥ 18 years old Life expectancy over 5 years Any race Ambulatory patients Painful primary coxarthrosis Painful secondary coxarthrosis Avascular necrosis Willingness to comply with rehabilitation and study evaluation and ability to return for follow-up visits Signed study-specific Informed Consent Form Exclusion Criteria: Body mass index over 28 kg/m2 for the modular version Requiring revision of previous standard femoral stem 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 Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an HHS< 60 points Significant proven or suspicious infection of the target hip Any serious infectious disease before the study according to the Investigator Muscular insufficiency that may compromise functional recovery Proven osteopenia and osteoporosis severe enough to compromise the stem support according to the Investigator Known or suspicious hypersensitivity to the metal of the implant Recurrent medical history of immune-mediated reactions or other systemic immune disorders Vascular insufficiency or peripheral neuropathy of lower limbs severe enough to interfere with the study evaluation according to the Investigator Current treatment or treatment for any malignancy within the previous 2 years before the preoperative visit Previous organ transplant 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 Known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study Current alcoholism, and/or any known current addiction to pain medications or drugs Any psychiatric illness that would prevent comprehension of the details and nature of the study Participation in any experimental drug/device study within the 6 months prior to the preoperative visit Unwillingness or inability to comply with rehabilitation and to return for follow-up visits 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MINIMA stem|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) |  | 24 months | 
| UCLA activity score |  | 24 months | 
| Time up and go test (TUG) |  | 24 months | 
| Range of motion (ROM) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip disability and Osteoarthritis Outcome Score (HOOS) |  | 24 months | 
| Implant stability measured by radiographic evaluations |  | 24 months | 
| Revision rate |  | 24 months | 
| Incidence of device-related Adverse Events/Serious Adverse Events |  | 24 months |