## Protocol Section
### Identification Module
**NCT ID:** NCT04036279

**Acronym:** NANOS

**Brief Title:** NANOS Neck Preserving Hip Stem

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

#### Organization Study ID Info
**ID:** R11014-1
#### Organization
**Class:** INDUSTRY
**Full Name:** Smith & Nephew, Inc.
### Status Module
#### Completion Date
**Date:** 2023-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-05

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2023-03

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01-21

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2019-07-29
**Type:** ACTUAL
**Study First Submit Date:** 2019-07-25
**Study First Submit QC Date:** 2019-07-25
**Why Stopped:** This study was originally designed to meet MDR commitments. MDR Approval was secured without this study. Therefore, this study does not fulfil its role as a regulatory body commitment.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Smith & Nephew Orthopaedics AG

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Primary Osteoarthritis

- Secondary Osteoarthritis

- Dysplasia Osteoarthritis

- Avascular Femoral Neck Necrosis

- Post-Traumatic Femoral Neck Necrosis

- Intact Femoral Neck With Good Bone Quality

**Keywords:**

- NANOS

- Hip

- Neck Preserving Stem

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 130

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Total Hip Arthroplasty

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Any reported safety events or complications up to 10 years post study procedure

**Measure:** Intra- and peri-operative device-related adverse events (AE) and complications up to discharge

**Time Frame:** 10 years

**Description:** Any reported safety events or complications up to 10 years post study procedure

**Measure:** Postoperative AE up to 10 years

**Time Frame:** 10 years

**Description:** 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).

**Measure:** Evaluation of function, range of motion and pain assessed by Harris Hip Score

**Time Frame:** 10 years

**Description:** 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.

**Measure:** Evaluation of function, range of motion and pain as assessed by HOOS score

**Time Frame:** 10 years

**Description:** 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.

**Measure:** Evaluation of function, range of motion and pain as assessed by UCLA Activity Rating

**Time Frame:** 10 years

**Description:** Any radiographic changes up to 10 years post study procedure

**Measure:** Radiographic changes as defined by resorption, radiolucent lines, osteolysis, hypo- and hypertrophy, implant migration or loosening

**Time Frame:** 10 years

#### Primary Outcomes

**Description:** 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

**Measure:** Long term survivorship of Nanos

**Time Frame:** 10 years

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Clinic for Orthopedics

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Marburg

**Country:** Germany

**Facility:** University Marburg, Orthopedics and Rheumatology

**Zip:** 35043

**Location 2:**

**City:** Alkmaar

**Country:** Netherlands

**Facility:** Medisch Centrum Alkmaar

**Location 3:**

**City:** Piekary Śląskie

**Country:** Poland

**Facility:** Samodzielny Publiczny Wojewodzki Spital

**Zip:** 41-940

#### Overall Officials

**Official 1:**

**Affiliation:** Phillips University Marburg, Germany

**Name:** Turgay Efe, Dr.med

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17912

- Name: Osteoarthritis, Hip

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: HIGH

- As Found: Necrosis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000009336

- Term: Necrosis

### Misc Info Module

- Version Holder: 2024-05-24
