Consequence of the Learning Curve in Direct Anterior Appr... | NCT02645435

Studies
Consequence of the Learning Curve in Direct Anterior Approach for Total Hip Replacement

NCT02645435

Sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo

Status

Completed

Last Update Posted

Jan 1, 2016Estimated

Enrollment

69Actual

Phase

Phase 4

Conditions

Arthropathy of Hip
Surgery

Interventions

hip replacement

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

Dec 2015

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

Dec 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 29, 2015

First Submission Date that Met QC Criteria

Dec 31, 2015

First Posted Date

Jan 1, 2016Estimated

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

Dec 31, 2015

Last Update Posted Date

Jan 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Riccardo Compagnoni, Medical Doctor, Azienda Ospedaliera Bolognini di Seriate BergamoPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Bolognini di Seriate BergamoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Background:

Direct anterior approach to the hip (DAA) is being considered as one of the most promising minimally-invasive approaches in total hip arthroplasty (THA). Purpose of this study is to analyse influence of learning curve on clinical and radiographic outcome in direct anterior approach (DAA) for total hip replacement.

Methods:

The first 30 patients operated with DAA (group B) were compared to 39 patients operated by Hardinge approach (group A). Peri-and postoperative complications, Harris Hip Score (HHS), implant positioning, experienced pain and patient satisfaction were evaluated at a mean follow-up of 32 months.

Detailed Description

Methods:

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hip direct anterior approach	Active Comparator	Patients with hip arthritis	Procedure: hip replacement
Lateral hip approach	Active Comparator	Patients with hip arthritis	Procedure: hip replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hip replacement	Procedure	Total hip replacement	Hip direct anterior approach Lateral hip approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical outcome of direct hip approach	Harry's hip score, a clinical score used in orthopedic surgery to describe outcome of hip function	32 months

Secondary Outcomes

Measure	Description	Time Frame
radiological positioning of cup in the replaced hip	using standard x-ray of the hip placement of implants is measured in angles between the iliac line and component line for the cup	32 months
radiological positioning of the stem in replaced hip

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hip arthritis

Exclusion Criteria:

BMI>35

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

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

Browse Leaves

Not provided

Browse Branches

Not provided