Correlation Between Femoral Head and Cup Size and Postope... | NCT04637958

Studies
Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty

NCT04637958

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Nov 20, 2020Actual

Enrollment

463Actual

Phase

Not provided

Conditions

Femoral Head Size
Cup Size THP
Postoperatie Groin Pain

Interventions

Countries

Belgium

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

ID	Type	Description	Link
UZ Leuven	Other Identifier	UZ Leuven

Status Module

Record Verification Date

Nov 2020

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

Aug 2014Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Nov 16, 2020

First Posted Date

Nov 20, 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

Nov 16, 2020

Last Update Posted Date

Nov 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Research Orthopedie, Research, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA.

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

463Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pain		THA	Device: THA
no pain		THA	Device: THA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
THA	Device	Total hip arthroplasty	no pain pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all primary THA

Exclusion Criteria:

DDH-LCP
Acetabulum/femoral neck fracture

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

retrospective database THA

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven		3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23927907	Background	Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.