NCT03437343

Brief Summary

This study used 3D reconstructions from the EOS biplanar radiographic imaging system to perform leg length measurements before and after THA (Total hip arthroplasty) on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA and the relationships between the quality of life, estimated by the HOOS score (Hip disability and osteoarthritis outcome score), and the anatomy of the new hip in standing position.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

February 2, 2018

Last Update Submit

February 12, 2018

Conditions

Keywords

EOStotal hip arthroplastyperformance of surgeonsleg length discrepancyHOOS

Outcome Measures

Primary Outcomes (1)

  • Change in anatomic lower limb length measurements between preoperative and postoperative measurements

    preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)

Secondary Outcomes (2)

  • Change in flessum/recurvatum/HKS angle (hip knee shaft ) measurements, between preoperative and postoperative measurements

    preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)

  • HOOS score (Hip disability and osteoarthritis outcome score)

    24 months after surgery

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.

You may qualify if:

  • unilateral total hip replacement for osteoarthritis or avascular necrosis healthy contralateral hip
  • age over 18 years
  • informed consent to participate in the study
  • radiographs obtained after total hip replacement using the EOS imaging system, filled HOOS form
  • clinical follow-up of 12 months at least

You may not qualify if:

  • past history of contralateral hip replacement
  • ipsi or contralateral knee replacement
  • hip arthroplasty performed using a Kerboull cross
  • post-operative complications such as infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leg Length Inequality

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 19, 2018

Study Start

January 1, 2015

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02