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Orthopedic Digital Planning for Total Hip Arthroplasties (ORTHOPLAN)

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ClinicalTrials.gov Identifier: NCT02842684
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Toulouse.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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 Phase 1 Phase 2

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : October 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

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



Primary Outcome Measures :
  1. postoperative inequality measured on the radiograph the 3rd postoperative day. [ Time Frame: day 3 after chirurgical intervention ]
    postoperative inequality measured on the radiograph the 3rd postoperative day.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842684


Contacts
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Contact: Nicolas Reina, Dr 05 61 77 55 83 reina.n@chu-toulouse.fr
Contact: Béatrice Appiah 05 61 77 87 71 appiah.b@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nicolas Reina, Dr University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02842684    
Other Study ID Numbers: RC31/14/7426
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No