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

Primary Total Hip Arthroplasty Clinical Trial

— Latearly  

Official title:

Randomized Comparison of Quality of Life and Functional Patients Undergoing Total Hip Replacement Uncemented. Load Early X Load Late

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01495546
• Other study ID #: CAPPesq0303
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2011
• Last updated: September 13, 2012
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: University of Sao Paulo
• Contact: Gisele P Mantelli
• Phone: 55 11 3069-6442
• Email: gpmantelli[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Primary Total Hip Arthroplasty

Intervention

Other:
• Early loading
Patients stepping down immediately after THA
• Late loading
Patients stepping down after three weeks of HTA

Locations

Country	Name	City	State
Brazil	Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time after THA	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	Until 6 weeks	No