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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Gisele Pucci Mantelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01495546
First received: December 12, 2011
Last updated: September 13, 2012
Last verified: September 2012

December 12, 2011
September 13, 2012
December 2011
December 2012   (final data collection date for primary outcome measure)
Recovery time after THA [ Time Frame: Until 6 weeks ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01495546 on ClinicalTrials.gov Archive Site
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Total Hip Arthroplasty (THA): Early Load Versus Load Late
Randomized Comparison of Quality of Life and Functional Patients Undergoing Total Hip Replacement Uncemented. Load Early X Load Late

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.

Not Provided
Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Primary Total Hip Arthroplasty
  • Other: Early loading
    Patients stepping down immediately after THA
  • Other: Late loading
    Patients stepping down after three weeks of HTA
  • Experimental: Early loading
    Intervention: Other: Early loading
  • Active Comparator: late loading
    Intervention: Other: Late loading
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
No
Contact: Gisele P Mantelli 55 11 3069-6442 gpmantelli@yahoo.com.br
Brazil
 
NCT01495546
CAPPesq0303
No
Gisele Pucci Mantelli, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP