NCT04090372

Brief Summary

Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

September 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

September 10, 2019

Last Update Submit

April 15, 2024

Conditions

Orthopedic Disorder

Keywords

OsteoarthritisHipTotal hip arthroplastyleg discrepancypreoperative planning

Outcome Measures

Primary Outcomes (1)

  • postoperative residual discrepancy

    The primary endpoint is the postoperative residual discrepancy measured on the radiographs on postop day 3 in millimeter compared using standard planning methods compared to TraumaCad.

    day 3

Secondary Outcomes (2)

  • comparisons of the reproducibility of the femoral implants sizes

    day 3

  • comparison of pelvis parameters

    day 3

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group will be assessed by standard preop planning using implants templates.

Device: evaluation of pre-op planning using Traumacad

TraumaCad Group

ACTIVE COMPARATOR

TraumaCad Group will be assessed by preop planning using Traumacad

Device: evaluation of pre-op planning using Traumacad

Interventions

evaluation of pre-op planning using TraumacadDEVICE

The study will be compare pre-op planning with standard condition or with TraumaCad

Control groupTraumaCad Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being older than18 years,
  • osteoarthritis as the indication for THA

You may not qualify if:

  • THAs after femoral neck fractures,
  • revision surgery,
  • major architectural anomaly (Bone tumor, prior fracture of the pelvis, hip dysplasia),
  • patients under legal protection,
  • pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesRheumatic Diseases

Study Officials

  • Nicolas Reina, MD

    CHU de Toulouse, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 16, 2019

Study Start

January 8, 2020

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)