Comparison of Balance and Fall Risk in Unilateral and Bilateral Total Knee Arthroplasty

March 10, 2021 updated by: Erman tütüncüler, Pamukkale University

A Comparison of Balance and Fall Risk in Patients With Unilateral and Bilateral Total Knee Arthroplasty

Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Falls are one of the leading causes of increased morbidity and mortality in the elderly population and are substantial contributor to increase healthcare cost burden. Pain, strength deficits, knee joint deformities, balance and proprioceptive impairments associated with severe knee OA, contribute to an increased risk of falling among elderly, and more than 50% of this population experience a fall each year. Static or dynamic postural control cannot be fully restored in patients with Total Knee Arthroplasty (TKA). Moreover, deficits in balance and postural control may still be present in both extremity after TKA. Increased weight-bearing on the operative side after TKA and reduced weight-bearing weight in the contralateral osteoarthritic knee can reduce pain and improve balance-related functions. However, the contralateral knee OA grade, asymmetrical gait pattern, and postural sways still remain a risk factor for balance deficits and falls. Based on this rationale, the aim of this study is to evaluate the balance and fall risk before and after TKA in patients who suffered from bilateral knee osteoarthritis and to clarify the balance and fall risk difference between unilateral and bilateral TKA patients.

Study Type

Interventional

Enrollment (Actual)

45

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

  • Turkey
      • Denizli, Turkey, 20010
        • Pamukkale University

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

42 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 55 to 85 years, patients with bilateral osteoarthritis, Kellgren-Lawrence grade 3-4, patients capable of understanding verbal and written instructions.

Exclusion Criteria:

  • revision TKA surgery, American Society of Anesthesiologists score >3, neurologic compromise, psychiatric problems, regular hypnotic and/or anxiolytic medication usage, dementia.

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral TKA
Unilateral total knee arthroplasty group (UTKA) consisted of patients who did not undergo a second TKA within 3 months of the first TKA
Procedure: Total knee arthroplasty
Surgical procedure
Experimental: Bilateral TKA
bilateral total knee arthroplasty group (BTKA) were those who had a second TKA within 12 months after initial TKA
Procedure: Total knee arthroplasty
Surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall risk evaluation
Time Frame: 3 months
Fall risk was evaluated using the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA). The Fall Risk test was conducted to identify potential fall candidates. Test results are compared with age-related normative data.
3 months
Balance evaluation
Time Frame: 3 months
Balance (Postural Stability and Sensory Integration) was evaluated using the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA). Postural Stability Test was applied to determine a patient's ability to maintain the centre of balance. Sensory Integration Test aims to evaluate the individual's ability to both integrate various senses to maintain balance and to compensate when one of these senses is missing. This test included four conditions: Eyes Open-Firm Surface, Eyes Closed-Firm Surface, Eyes Open-Foam Surface, and Eyes Closed-Foam Surface. Each assessment lasted 30 seconds, with 10 seconds of rest in between assessments.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index score
Time Frame: 3 months
It is a patient reported questionnaire that evaluates pain, stiffness, and physical function in patients with hip and knee OA. The index consists of 24 questions and is completed in less than 5 minutes. The scores of the questions range from 0 (none) to 4 (very severe) and the results are evaluated over 100 points (minimum score:0 and the maximum score:100). Higher scores indicates worst knee functions.
3 months
Quality of life measure
Time Frame: 3 months
Patients' quality of life were evaluated with Short Form-12 for seconder outcome. Higher scores indicates better quality of life.
3 months
Sit-to-stand test
Time Frame: 3 months
The patient was seated in the middle of a chair with a height of 44 cm, with his back straight, arms crossed in front of his chest, and feet on the ground. The patient was asked to get up from the chair and sit down as much as the patient could for 30 seconds. The exact number of starts made formed the patient's score. Higher scores indicates better overall strength.
3 months
9-step stair climbing test
Time Frame: 3 months
The patient was asked to climb and descend the 9-step 16-20 centimeter ladder as quickly but safely as possible. The patient was allowed to use a handrail or a walking aid, and the method used was recorded. The test was started with the start command and the time stopped when the patient returned to the starting place. The patient was allowed to stop and rest when requested, but the duration was continued. The total time was recorded as a score. Lower scores indicates better knee functions.
3 months
40 m fast-paced walk test
Time Frame: 3 months
Patients were asked to walk along the 10-meter track without running but as fast as possible, turn around the cone at the finish, and complete the 40-meter total distance. After the patient passed the baseline in the last stage, the time was stopped and the total time was recorded. Lower scores indicates better walking capacity.
3 months

Collaborators and Investigators

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

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Erman Tütüncüler, Dr., Pamukkale University

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

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 (Actual)

April 10, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

October 10, 2020

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Balance, Fall risk after TKA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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