NANOS Neck Preserving Hip Stem | NCT04036279

Studies
NANOS Neck Preserving Hip Stem

NCT04036279

Sponsor

Smith & Nephew Orthopaedics AG

Status

Terminated

Last Update Posted

Jun 7, 2023Actual

Enrollment

130Actual

Phase

Not provided

Conditions

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

Interventions

Total Hip Arthroplasty

Countries

Germany
Netherlands
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

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.

Expanded Access Info

Start Date

Jan 21, 2010Actual

Primary Completion Date

Mar 2023Actual

Completion Date

Mar 2023Actual

First Submitted Date

Jul 25, 2019

First Submission Date that Met QC Criteria

Jul 25, 2019

First Posted Date

Jul 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2023

Last Update Posted Date

Jun 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Name	Type	Description	Arm Group Labels	Other Names
Total Hip Arthroplasty	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Clinic for Orthopedics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Turgay Efe, Dr.med	Phillips University Marburg, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Marburg, Orthopedics and Rheumatology		Marburg		35043	Germany
Medisch Centrum Alkmaar

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019644	Arthroplasty, Replacement, Hip

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

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Browse Branches

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