Anatomical Femoral Stem in Total Hip Arthroplasty | NCT04243980

Studies
Anatomical Femoral Stem in Total Hip Arthroplasty

NCT04243980

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Jan 28, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Patient Compliance
Patient Satisfaction

Interventions

Short anatomical femoral stem in THR

Countries

Not provided

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Estimated

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Jan 23, 2020

First Submission Date that Met QC Criteria

Jan 26, 2020

First Posted Date

Jan 28, 2020Actual

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

Jan 26, 2020

Last Update Posted Date

Jan 28, 2020Actual

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

A study that detect the femoral anteversion after total hip arthroplasty using short anatomical femoral stem compared to the contrast side

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients after total hip arthroplasty with short femoral stem	Device: Short anatomical femoral stem in THR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Short anatomical femoral stem in THR	Device	Patients with osteoarthritis after total hip arthroplasty	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Femoral anteversion	comparing femoral anteversion after THR using CT scan	Post-Operatively, through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Harris Hip Score	The HHS is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). Where a score < 70 indicating a poor result and those of 90-100 indicating an excellent result	6 weeks, 3 month, 6 month post-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-90
patients who had THR as an elective surgery
patients who had THR with short femoral anatomical stem

Exclusion Criteria:

severe osteoporosis with Dorr C classification
s/p bilateral hip arthroplasty
non-complaint patients
revision surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients aged 18 - 90 who had THR as an elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Raja Hakim, M.D.	Contact	00972546612251		raja.hakim@icloud.com

Overall Officials

Not provided

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D010349	Patient Compliance
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided