Total Hip Arthroplasty (THA): Early Load Versus Load Late (Latearly)
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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 |
- 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 |
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| Contact: Gisele P Mantelli | 55 11 3069-6442 | gpmantelli@yahoo.com.br |
| 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 | |
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 May 19, 2013