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Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters

NCT02047292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-17

No results posted yet for this study

Summary

Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are:

* What role do soft tissues play in limiting ROM?
* Can prosthetic impingement really occur in a well positioned THA?
* Can a bigger head diameter alone reduce the risk of impingement?

Conditions

  • Hip Osteoarthritis

Interventions

DEVICE

THA Corail PinnacleCoC28

Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head

DEVICE

THA Corail DeltaMotion36

Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head

DEVICE

THA Corail DeltaMotion40

Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head

Sponsors & Collaborators

  • DePuy International

    collaborator INDUSTRY

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Sandro Giannini, MD, Prof · Istituto Ortopedico Rizzoli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-02-29
Completion
2017-12-21

Countries

  • Italy

Study Locations

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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 NCT02047292 on ClinicalTrials.gov