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

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.

Study Overview

• Status: Unknown
• Conditions: Primary Total Hip Arthroplasty
• Intervention / Treatment: Other: Early loading; Other: Late loading

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Recruiting
    • Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
    • Contact: Gisele P Mantelli, Physiotherapist; Phone Number: 55 11 3069-6442; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (Estimate): December 20, 2011

Study Record Updates

• Last Update Posted (Estimate): September 17, 2012
• Last Update Submitted That Met QC Criteria: September 13, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: total hip arthroplasty; THA; prosthesis type Lepine
• Other Study ID Numbers: CAPPesq0303