Home Rehabilitation in Patients After Primary Total Knee Arthroplasty

December 2, 2019 updated by: FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 World Health Organization 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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 66235
        • Facultad de Medicina UANL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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
  • Patients with hemoglobin values < 11g/dl , platelets < 150,000/ μL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control - Verbal information and Booklet
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Other: Verbal Information and Booklet
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Other Names:
  • Verbal and Booklet Physical Rehabilitation information
Experimental: Study - Verbal information, Booklet & Schedule.
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Other: Verbal Information and Booklet
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Other Names:
  • Verbal and Booklet Physical Rehabilitation information
Other: Schedule
Illustrative daily planner to point the day that the exercise was performed
Other Names:
  • Planner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total WOMAC Score
Time Frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC).

It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales:

pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints.

  • Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96.
  • For each subscale higher values represent worse outcomes.
  • Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities.
up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (Measure of Pain Intensity)
Time Frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)
The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (scale of 10).
up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score (OKS)
Time Frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

The Oxford Knee Score is a 12-item patient-reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.

Consists of 12 multiple choice questions consisting of five answers with a maximum score of 60.

Score ranges

  • Score 0 to 19: May indicate severe knee arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon.
  • Score 20 to 29: May indicate moderate to severe knee arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon.
  • Score 30 to 39: May indicate mild to moderate knee arthritis. Consider seeing your family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory med
up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Investigators

  • Principal Investigator: Felix Vilchez, MD-PhD, Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OR14-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Verbal Information and Booklet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe