ORTHOPLAN: Orthopedic Digital Planning for Total Hip Arthroplasties

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT02842684

Collaborator

(none)

1,000

Enrollment

Location

Arms

Anticipated Duration (Months)

28.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection of Total Hip Joint Prosthesis	Device: TraumaCad software	N/A

Detailed Description

Modern joint replacements in orthopedic surgery allow to restore locomotion. More than 150,000 hip replacements are performed each year in France . The optimization results going restoration of the lengths of members and anatomy .

Preoperative planning of hip replacements optimizes the return of the hip rotation center . 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 parameters of the hip.

Preoperative planning by TraumaCad hip arthroplasties provides better restitution of limb length over conventional planning methods.

The standardized radiographs being the investigators want to compare this group with a control group operated without TraumaCad planning and evaluating the accuracy of the software to predict implants sizes also .

There is no risk to the patient with this procedure . The direct benefit is increased accuracy of surgical gesture to the patient and the reduction of mechanical problems related to leg length . Earnings for the orthopedic community is the postoperative evaluation. In the long term , the prosthetic technical improvement must increase the life of prostheses with therefore lower revisions and less expenditure in terms of public health.

The widespread use of automated planning and objective assessment postoperative radiographs .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Orthopedic Digital Planning for Total Hip Arthroplasties

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Traumacad software 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 restitution of anatomical- radiological parameters after total hip arthroplasty with TraumaCad , conventional planning systems and without planning.
No Intervention: without digital planning Preoperative planning of hip prothesis is practiced by layer on radiographs whose scaling is imprecise

Arm

Intervention/Treatment

Experimental: Traumacad software

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

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

No Intervention: without digital planning

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

Outcome Measures

Primary Outcome Measures

postoperative inequality measured on the radiograph the 3rd postoperative day. [day 3 after chirurgical intervention]
postoperative inequality measured on the radiograph the 3rd postoperative day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion concerns all major patients able supported for osteoarthritis for the realization of a primary hip replacement .

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Toulouse		France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Nicolas Reina, Dr, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT02842684

Other Study ID Numbers:

RC31/14/7426

First Posted:

Jul 25, 2016

Last Update Posted:

Aug 27, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 27, 2021