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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02842684
Other study ID # RC31/14/7426
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date January 15, 2023

Study information

Verified date June 2024
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 ( BrainlabĀ® ) 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 .


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms

  • Infection of Total Hip Joint Prosthesis

Intervention

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

Locations

Country Name City State
France University Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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