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Total Hip Arthroplasty (THA): Early Load Versus Load Late

NCT ID: NCT01495546

Last Updated: 2012-09-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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In Brazil, several hip surgeries performed, especially total knee arthroplasty, which represents 1.5 million procedures (Penedo, New, 2007). The rehabilitation of these individuals is slow with respect to the march because it requires an aid and not to use the operated leg as support for three weeks, according to conventional methods. After the third week, the support becomes part and after that period (sixth week), the support becomes total. Therefore, and in order to provide better quality of life, the goal of this work is to compare the march in 40 patients divided into two groups of 20 subjects each. In the control group, the treatment approach is the traditional, i.e., without immediate loading, while the other charge will be applied immediately in the operated limb. In order to verify the possible gain in the quality of life of these patients, the SF-36 will be applied. The march will be assessed with the Time Up and Go test and the force platform and the Harris Hip score analyze the function of the hip. Individuals will receive such care at the Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (IOT - HC - USP). The results of comparisons between the two groups and the clinical findings obtained will be subjected to appropriate statistical tests, guided by the principles of evidence-based clinical practice, seeking to facilitate and improve the lives of these individuals so they can move freely.

Detailed Description

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Conditions

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Primary Total Hip Arthroplasty

Keywords

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total hip arthroplasty THA prosthesis type Lepine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early loading

Group Type EXPERIMENTAL

Early loading

Intervention Type OTHER

Patients stepping down immediately after THA

late loading

Group Type ACTIVE_COMPARATOR

Late loading

Intervention Type OTHER

Patients stepping down after three weeks of HTA

Interventions

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Early loading

Patients stepping down immediately after THA

Intervention Type OTHER

Late loading

Patients stepping down after three weeks of HTA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients served by the institution with THA without cement;
* BMI less than 40, ie, present in most class II obesity;
* Patients with diseases such as osteoarthritis and osteonecrosis of the femoral head;
* Absence of systemic involvement;
* Patients with prosthetic type Lépine.

Exclusion Criteria

* Bilateral arthroplasty;
* Partial arthroplasty;
* Arthroplasties for review;
* Cemented arthroplasties;
* Surgical complications.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Gisele Pucci Mantelli

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Gisele P Mantelli

Role: CONTACT

Phone: 55 11 3069-6442

Email: [email protected]

Facility Contacts

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Gisele P Mantelli, Physiotherapist

Role: primary

Other Identifiers

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CAPPesq0303

Identifier Type: -

Identifier Source: org_study_id