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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495546
Recruitment Status : Unknown
Verified September 2012 by Gisele Pucci Mantelli, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 20, 2011
Last Update Posted : September 17, 2012
Information provided by (Responsible Party):
Gisele Pucci Mantelli, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Total Hip Arthroplasty Other: Early loading Other: Late loading Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Comparison of Quality of Life and Functional Patients Undergoing Total Hip Replacement Uncemented. Load Early X Load Late
Study Start Date : December 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Early loading Other: Early loading
Patients stepping down immediately after THA

Active Comparator: late loading Other: Late loading
Patients stepping down after three weeks of HTA

Primary Outcome Measures :
  1. Recovery time after THA [ Time Frame: Until 6 weeks ]
    Patients will be evaluated in the following periods: THA pre-surgery, the third day post-surgery THA, third and sixth week post-surgery THA, third and sixth months after surgery THA

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01495546

Contact: Gisele P Mantelli 55 11 3069-6442

Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Gisele P Mantelli, Physiotherapist    55 11 3069-6442   
Principal Investigator: Rodrigo ES da Silva, Physiotherapist         
Principal Investigator: Alberto T Croci, Full professor         
Sub-Investigator: Alexandre S da Silva, Master         
Sub-Investigator: Cristiane Miyashiro, Physiotherapist         
Sub-Investigator: Julia MA Greve, Phd         
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Gisele Pucci Mantelli, Physiotherapist, University of Sao Paulo Identifier: NCT01495546     History of Changes
Other Study ID Numbers: CAPPesq0303
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Gisele Pucci Mantelli, University of Sao Paulo:
total hip arthroplasty
prosthesis type Lepine