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

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-21

Brief Summary

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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?

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Detailed Description

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This will be a prospective comparative randomized double-blind Study (both patient and the clinical engineer performing the gait analysis will be blind with respect to the prosthetic head diameter implanted). Patient recruitment will last 12 months and the Study will have a follow-up period of 12 months. A total number of 45 patients will be recruited. Patients will be randomly allocated into three groups: the first group will undergo THA with a 28mm diameter head (Pinnacle Acetabular System, with a ceramic on ceramic - CoC - bearing), in the second group THA will be performed using a 36 mm diameter head (DeltaMotion), finally patients in the third group will undergo THA with a 40 mm diameter head (DeltaMotion). Patients will be operated by three surgeons of the same hospital according to the same surgical procedure and using the same direct lateral approach. All patients will receive a Corail stem and will follow the same rehabilitation program.

* Primary endpoint: Gait analysis and fluoroscopy will provide quantitative information of prosthesis in vivo performance, e.g. what is the arc (degrees) of active or passive motion when prosthetic impingement occurs?
* Secondary endpoint(s): these analyses will also allow to: 1) assess ROM of the operated hip versus contralateral non operated hip and the effect of prosthetic head diameter and any correlation to hip functional scores validated and commonly used in the Literature; 2) set reproducible criteria for in vivo fluoroscopic analysis of ROM in THA patients.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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THA28

THA Corail PinnacleCoC28

Group Type ACTIVE_COMPARATOR

THA Corail PinnacleCoC28

Intervention Type DEVICE

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

THA36

THA Corail DeltaMotion36

Group Type ACTIVE_COMPARATOR

THA Corail DeltaMotion36

Intervention Type DEVICE

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

THA40

THA Corail DeltaMotion40

Group Type ACTIVE_COMPARATOR

THA Corail DeltaMotion40

Intervention Type DEVICE

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

Interventions

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THA Corail PinnacleCoC28

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

Intervention Type DEVICE

THA Corail DeltaMotion36

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

Intervention Type DEVICE

THA Corail DeltaMotion40

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with unilateral primary or secondary hip arthrosis indicated for THA;
* Men and female, age between 35 and 55 years old;
* BMI smaller than 30;
* Patients able to understand the protocol and to sign the informed consent.

Exclusion Criteria

* Child-bearing female;
* Patients with also controlateral hip arthritis;
* Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip;
* Patients treated with joint replacement at any other lower limb articulation

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No