Home Rehabilitation in Patients After Primary Total Knee Arthroplasty
Phase: NA
Conditions: Osteoarthritis, Rehabilitation
Sponsor: Universidad Autonoma de Nuevo Leon

 
Home Rehabilitation in Patients After Primary 
Total Knee Arthroplasty 
NCT02409719 
Document Date: October 21, 2019 
Date of Study Closure: January 24 2019 
Statystical Analysis 
Sample was calculated that 76 participants per group using media difference test  with a 
standard deviation of 7  and an expected magnitude of difference at least five pints on the 
WOMAC scale with a power of β 80%, confidence 95% with statistically significant p of  <=0.05 
with a 20% error. 
Brief Summary: 
The investigators include patients attending the outpatient clinic in the area of Orthopedics 
and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which 
treatment requires surgery. Patients will be divided into two groups. In both groups, they will 
be given verbal, clear and detailed information on the approach to follow, the exercises given 
in brochures, and in the study group a schedule will be given in order to record rehabilitation 
exercises in patients after total knee replacement (TKA). Both groups will be assessed before 
and after surgery, together with outpatient follow-up by, WOMAC, Visual Analogue Scale and 
OKS (Oxford Knee Score). 
Detailed Description: 
Osteoarthritis (OA) is the most common rheumatic disease worldwide. OA cause joint pain and 
occupational disability in the adult population. In Mexico, OA is one of the top ten reasons of 
consultation in primary attention care. 
Joint arthroplasty is a major advance in the treatment of chronic joint pain. It is indicated in 
patients in whose conservative medical therapy has failed. Total knee arthroplasty (TKA) is a 
surgery that reduces pain and improves function and quality of life in patients with knee 
disorders, actually is one of the most successful medical procedures. However, a critical 
consideration in patients with TKA is the successful control of postoperative pain. An adequate 
pain control allows faster rehabilitation, reduces complications and is highly correlated with 
patient satisfaction. A multimodal pain management decreases the use of narcotics, improve 
pain scores, increase patient satisfaction and allows early recovery. 
Regarding postoperative rehabilitation, its suggested that rehabilitation programs are based 
on a biopsychosocial philosophy and integrate exercises and self-management interventions 
are effective in the treatment of osteoarthritis. Rehabilitation therapy an important area that 
should be considered. It helps people recover faster from their illness, injury or medical 
procedures and make possible to get back to their daily activities. 

The WHO describes rehabilitation as a process that aims to enable people to maintain and 
achieve their physical, sensory, intellectual, functional, psychological and social level in an 
optimal way. It is known that rehabilitation involves contributions from various health 
disciplines, including physical therapy and occupational therapy and offered in inpatient, 
outpatient and community patients. 
In patients with total knee replacement, rehabilitation interventions may involve education 
and exercise before surgery, early mobilization while being in the hospital and a postoperative 
program, along with an adequate pain management. 
Perioperative care has shown an improvement in the recovery, it reduces hospital day stay, 
convalescent and risk of postoperative medical complications. 
It has been shown that early initiation of rehabilitation within 24 hours after total knee 
arthroplasty reduces in-hospital time and decreases the number of sessions required to 
achieve autonomy, balance and normal gait. Madsen et al. demonstrated that rehabilitation 
exercises at home have the same effect as those made in rehabilitation group within six 
months postoperatively, based on a study of 80 patients randomly divided into a control- study 
group. 
Optimal pain management is vital seeking to achieve the goal of recovery called fast track. It 
involves early therapy with specialized protocols, early discharge and quick recovery. Lamplot 
et al. demonstrated in a prospective randomized study of 36 patients, using this method, a 
decrease in opioid consumption and its adverse effects, a decreased pain score, a shortening 
time for physical therapy and an increase in patient satisfaction. 
Postoperative analgesia can be achieved by a variety of techniques. These include: intravenous 
analgesia, epidural analgesia, techniques for peripheral nerve block and periarticular 
injections. All aim to control pain in patients and provide the better satisfaction. 
Integrating these interventions in a clinical pathway, better functional results are obtained, 
hospital stay is reduced and there is an improvement in the patient's recovery, mainly in short-
term. 
Minimum Age: 18 Years  Maximum Age: 
90 Years   Sex: All   Gender Based: - 
  
Accepts Healthy Volunteers: 
No    
Criteria: 
 
 
Inclusion Criteria: Age between 18 and 90 years,Patients with Knee osteoarthritis (OA) 
grade 4 ( Kellgren-Lawrence based on radiographic findings),Total Knee Arthroplasty 
(TKA) for primary OA and Rapid rehabilitation desire. 
 
Exclusion Criteria: Age <18 and > 90 years, Patients with Knee osteoarthritis grade 1-2 ( 
Kellgren-Lawrence based on radiographic findings), Patients with asociated Rheumatic 
syndromes, Patients with anticoagulant therapy, Patients with hepatic problems, 
Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections, 

Drugs abuse history, Physiatric disease, Pregnant patients and Patients with 
hemoglobin values < 11g/dl , platelets < 150,000/uL. 
Location  
Mexico, Facultad de Medicina UANL, Monterrey, Nuevo Leon, Mexico, 66235   
Contact: Felix Vilchez, MD-PhD       fvc78@hotmail.com 
Contact: Yadira Tamez, Dr.    005218118790197    yad.tmz@gmail.com 
Principal Investigator: Felix Vilchez, MD-PhD 
Sub-Investigator: Yadira Tamez, Dr. 
 
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Links: URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3092498/ 
Description: Epidemiology of Knee and Hip Arthroplasty: A Systematic Review 
URL: http://emedicine.medscape.com/article/320061-overview 
Description: Total Joint Replacement Rehabilitation