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

NCT01495546 | Unknown

• 1 other identifier: CAPPesq0303
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Total Hip Arthroplasty

Keywords

total hip arthroplasty; THA; prosthesis type Lepine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Early loading

EXPERIMENTAL

Other: Early loading

late loading

ACTIVE COMPARATOR

Other: Late loading

Interventions

Early loading OTHER

Patients stepping down immediately after THA

Early loading

Late loading OTHER

Patients stepping down after three weeks of HTA

late loading

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Bilateral arthroplasty;
• Partial arthroplasty;
• Arthroplasties for review;
• Cemented arthroplasties;
• Surgical complications.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Orthopedics and Traumatology, Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Central Study Contacts

Gisele P Mantelli

CONTACT

55 11 3069-6442; gpmantelli@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

BR (1)