NCT02842684

Brief Summary

Preoperative planning has been carried out to allow for response preparedness . A layer technique is usually used with standard radiography .The investigators have a record of routine preoperative radiographs by standard recognized as having an advantage over the reproducibility of measurements compared with plain radiography . The Toulouse Hospitals have developed this technology and is part of the routine assessment of hip prothesis pre and postoperatively. The TraumaCad software can superimpose implants on Picture Archiving and Communication System and evaluate digital and reproducible size of the implants and their correct position . This is to demonstrate the superiority of modern digital tools in the preoperative preparation in Orthopaedics set.

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 Oct 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
3.2 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.3 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

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

3.3 years

First QC Date

July 20, 2016

Last Update Submit

June 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative inequality measured on the radiograph the 3rd postoperative day.

    postoperative inequality measured on the radiograph the 3rd postoperative day.

    day 3 after chirurgical intervention

Study Arms (2)

Traumacad software

EXPERIMENTAL

Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise . The recent TraumaCad system ( Brainlab® ) allows adjustment of the scales for each patient and the virtual positioning of implants to simulate the response to the return of geometric hip parameters

Device: TraumaCad software

without digital planning

NO INTERVENTION

Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise

Interventions

restitution of anatomical- radiological parameters after total hip arthroplasty with TraumaCad , conventional planning systems and without planning.

Traumacad software

Eligibility Criteria

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

You may not qualify if:

  • Minor patients
  • BMI greater than 35 patients
  • Recovery or major architectural disorder surgery ( preoperative upper inequality 2 cm or dysplastic hip)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, France

Location

Study Officials

  • Nicolas Reina, Dr

    University Hospital, Toulouse

    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

July 20, 2016

First Posted

July 25, 2016

Study Start

October 1, 2019

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations