NANOS Neck Preserving Hip Stem

Smith & Nephew

Status: Terminated

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

Treatments: Procedure: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04036279

R11014-1

Details and patient eligibility

About

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

Full description

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

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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