NANOS Neck Preserving Hip Stem (NANOS)

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

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

Study Overview

• Status: Terminated
• Conditions: Primary Osteoarthritis; Secondary Osteoarthritis; Dysplasia Osteoarthritis; Avascular Femoral Neck Necrosis; Post-Traumatic Femoral Neck Necrosis; Intact Femoral Neck With Good Bone Quality
• Intervention / Treatment: Procedure: Total Hip Arthroplasty

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

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35043
    • University Marburg, Orthopedics and Rheumatology
• Netherlands
  • Alkmaar, Netherlands
    • Medisch Centrum Alkmaar
• Poland
  • Piekary Śląskie, Poland, 41-940
    • Samodzielny Publiczny Wojewodzki Spital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Clinic for Orthopedics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra- and peri-operative device-related adverse events (AE) and complications up to discharge	Any reported safety events or complications up to 10 years post study procedure	10 years
Postoperative AE up to 10 years	Any reported safety events or complications up to 10 years post study procedure	10 years
Evaluation of function, range of motion and pain assessed by Harris Hip Score	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).	10 years
Evaluation of function, range of motion and pain as assessed by HOOS score	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.	10 years
Evaluation of function, range of motion and pain as assessed by UCLA Activity Rating	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.	10 years
Radiographic changes as defined by resorption, radiolucent lines, osteolysis, hypo- and hypertrophy, implant migration or loosening	Any radiographic changes up to 10 years post study procedure	10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Turgay Efe, Dr.med, Phillips University Marburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2010
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hip; NANOS; Neck Preserving Stem
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis
• Other Study ID Numbers: R11014-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No