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Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study

NCT05120063 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2023-08-15

No results posted yet for this study

Summary

In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement.

Hypothesis:

1. When compared to 2-D planning, 3-D planning of a THR results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.
2. When compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.

Conditions

  • Hip Injuries
  • Surgery
  • Prosthesis User

Interventions

DEVICE

SPS monoblock stem, Symbios

hip prosthesis

DEVICE

Quadra-H, Medacta

hip prosthesis

PROCEDURE

3D planning of THR

primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography)

PROCEDURE

2D planning of THR

primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray)

Sponsors & Collaborators

  • Symbios Orthopedie SA

    collaborator INDUSTRY

  • Balgrist University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-01
Primary Completion
2030-01-28
Completion
2030-01-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120063 on ClinicalTrials.gov