Assessment of Implant Fixation and SF-36 for Short Hip-St... | NCT04172129

Studies
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study

NCT04172129

Sponsor

Smith & Nephew Orthopaedics AG

Status

Completed

Last Update Posted

Nov 27, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Primary and Secondary Coxarthrosis
Dysplasia Coxarthrosis
Post-traumatic Necrosis of the Femoral Head

Interventions

Total Hip Arthroplasty

Countries

Germany

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2011Actual

Primary Completion Date

Jan 4, 2017Actual

Completion Date

Feb 15, 2017Actual

First Submitted Date

Nov 19, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 21, 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

Nov 25, 2019

Last Update Posted Date

Nov 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

Detailed Description

Not provided

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

60Actual

Label	Type	Description	Intervention Names
NANOS		NANOS™ Neck Preserving Hip Stem	Device: Total Hip Arthroplasty

Name	Type	Description	Arm Group Labels	Other Names
Total Hip Arthroplasty	Device		NANOS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of migration pattern of the Nanos stem	Measuring migration used the model-based RSA method	2 years
Change in quality of life	Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score Minimum Value: 0 (worst outcome) Maximum Value: 100 (best outcome)	2 years

Secondary Outcomes

Measure	Description	Time Frame
Harris Hip Score	Investigator assessed outcome score Minimum: 0 (worst outcome) Maximum: 100 (best outcome)	2 years
University of California, Los Angeles (UCLA) scale	Score rating the patient's current activity level Minimum: 1 (wholly inactive subject) Maximum: 10 (totally active subject)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
Subject was 30 to 65 (inclusive) years of age at time of surgery.

Exclusion Criteria:

Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
Subject had a local or systemic infection.
Subject had previously diagnosed osteoporosis.
Subject had a femoral neck angle of >145°.
Subject had a femoral neck angle of <125°.
Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
Subject had a documented allergy against elements of the implanted device.
Subject had a neurological disease with changed motor function.
Subject was pregnant.
Subject had a Body Mass Index (BMI) > 30.
Subject suffered from alcoholism or addictive disorders.
Subject needed a revision hip arthroplasty.
Subject had an insufficient command of the language to understand patient information and consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients identified in the primary care clinic with need for total hip arthroplasty

Sampling Method

Non-Probability Sample

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