Avascular Femoral Neck Necrosis, Dysplasia Osteoarthritis, Intact Femoral Neck With Good Bone Quality, Post-Traumatic Femoral Neck Necrosis, Primary Osteoarthritis, Secondary Osteoarthritis
Conditions
Keywords
NANOS, Hip, Neck Preserving Stem
Brief summary
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
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
Interventions
PROCEDURETotal Hip Arthroplasty
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long term survivorship of Nanos | 10 years | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative AE up to 10 years | 10 years | Any reported safety events or complications up to 10 years post study procedure |
| Evaluation of function, range of motion and pain assessed by Harris Hip Score | 10 years | Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best). HHS scores for each subject will further be categorized as follows: Excellent (90-100); Good (80-89); Fair (70-79); Poor (60-69) and; Very poor (\<60). |
| Intra- and peri-operative device-related adverse events (AE) and complications up to discharge | 10 years | Any reported safety events or complications up to 10 years post study procedure |
| Evaluation of function, range of motion and pain as assessed by UCLA Activity Rating | 10 years | UCLA Activity Score is a measure of physical activity levels in subjects undergoing total joint arthroplasty. The scale is from 1 - 10 with higher values indicating greater physical function. |
| Radiographic changes as defined by resorption, radiolucent lines, osteolysis, hypo- and hypertrophy, implant migration or loosening | 10 years | Any radiographic changes up to 10 years post study procedure |
| Evaluation of function, range of motion and pain as assessed by HOOS score | 10 years | HOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. |
Countries
Germany, Netherlands, Poland
Outcome results
None listed