NANOS Neck Preserving Hip Stem

Study Overview
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Brief Summary
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The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship

Detailed Description
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The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem. Effectiveness Measures: Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score [4-6], UCLA Activity Rating [7] Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: Intra- and peri-operative device-related adverse events (AE) and complications up to discharge Postoperative AE up to 10 years

Official Title
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A Prospective, Multicenter, Clinical Outcome Study of the NANOS Neck Preserving Stem in Patients With Degenerative Hip Joint Disease

Conditions
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Primary Osteoarthritis, Secondary Osteoarthritis, Dysplasia Osteoarthritis, Avascular Femoral Neck Necrosis, Post-Traumatic Femoral Neck Necrosis, Intact Femoral Neck With Good Bone Quality

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if >3 months after the first THR Patient agreed to participate in the MCO study by signing the Informed Consent form. Age of patient at date of surgery 18 to 65 years Patient is likely to comply with study follow-up requirements Exclusion criteria: Previously failed endoprosthesis and /or THR components in relevant hip Patient has proven osteoporosis Pronounced coxa valga with a femoral neck angle > 145º Pronounced coxa vara with a femoral neck angle < 125º History of infection in the affected joint; systemic infections Grossly insufficient femoral or acetabular bone stock in the involved hip where a revision cup is indicated Spinal disease with neurologic movement disorders Alcoholism or addictive disorders ASA score is 3 or 4 Body mass index (BMI) > 30 Patient is pregnant or being pregnant during follow up intervals Patients understanding of the language is insufficient for understanding the Patient Information and Consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- |
|Procedure: Total Hip Arthroplasty|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term survivorship of Nanos | Revision for any reason. Implant survivorship at 10 years post study procedure. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NANOS, Hip, Neck Preserving Stem