NANOS Neck Preserving Hip Stem

Smith & Nephew Orthopaedics AG130 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

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

Interventions

Total Hip ArthroplastyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

University Marburg, Orthopedics and Rheumatology

Marburg, Germany

Medisch Centrum Alkmaar

Alkmaar, Netherlands

Samodzielny Publiczny Wojewodzki Spital

Piekary Śląskie, Poland

Outcomes

Primary Outcomes

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

Time frame: 10 years

Data from ClinicalTrials.gov

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