NANOS Neck Preserving Hip Stem

Terminated

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

• Registration Number: NCT04036279
• Lead Sponsor: Smith & Nephew Orthopaedics AG

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

Study Timeline

• Study Start: 2010-01-21
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University Marburg, Orthopedics and Rheumatology; 🇩🇪 Marburg, Germany

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands

Samodzielny Publiczny Wojewodzki Spital; 🇵🇱 Piekary Śląskie, Poland