Digital Preop-planning of Total Hip Arthroplasties

NCT ID: NCT04090372

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2023-01-15

Brief Summary

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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

Detailed Description

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Total hip arthroplasties (THAs) are used to restore locomotion. More than 150,000 THAs are performed each year in France. Better outcomes require a restoration of limb lengths and anatomy. Post-operative discrepancy is the main cause of complaints and financial compensation in the US after THA. As such, the investigators aim to use preoperative digital planning using TraumaCad to optimize the restoration of the center of rotation of the hips. Preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. The TraumaCad system (BrainlabĀ®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.

Conditions

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Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

evaluation of pre-op planning using Traumacad

Intervention Type DEVICE

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

TraumaCad Group

TraumaCad Group will be assessed by preop planning using Traumacad

Group Type ACTIVE_COMPARATOR

evaluation of pre-op planning using Traumacad

Intervention Type DEVICE

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

Interventions

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evaluation of pre-op planning using Traumacad

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Reina, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Toulouse, France

Locations

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CHU de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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14 7426 15

Identifier Type: -

Identifier Source: org_study_id

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