NCT04637958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

November 16, 2020

Last Update Submit

November 16, 2020

Conditions

Femoral Head SizeCup Size THPPostoperatie Groin Pain

Outcome Measures

Primary Outcomes (1)

  • Correlation between femoral head and cup size and postoperative pain in Total Hip arthroplasty

    1 year

Study Arms (2)

pain

THA

Device: THA

no pain

THA

Device: THA

Interventions

THADEVICE

Total hip arthroplasty

no painpain

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective database THA

You may qualify if:

  • all primary THA

You may not qualify if:

  • DDH-LCP
  • Acetabulum/femoral neck fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 23927907BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

BE(1)