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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention
Primary Total Hip Arthroplasty
Other: Early loading
Other: Late loading

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 45
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495546

Contacts
Contact: Gisele P Mantelli 55 11 3069-6442 gpmantelli@yahoo.com.br

Locations
Brazil
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    gpmantelli@yahoo.com.br   
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
  More Information

No publications provided

Responsible Party: Gisele Pucci Mantelli, Physiotherapist, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01495546     History of Changes
Other Study ID Numbers: CAPPesq0303
Study First Received: December 12, 2011
Last Updated: September 13, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
total hip arthroplasty
THA
prosthesis type Lepine

ClinicalTrials.gov processed this record on October 21, 2014