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

Knee Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796519
• Other study ID #: Balance, Fall risk after TKA
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: October 10, 2020

Study information

• Verified date: March 2021
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 10, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 46 Years to 82 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Procedure:
• Total knee arthroplasty
Surgical procedure

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bakirhan S, Angin S, Karatosun V, Ünver B, Günal I. Physical performance parameters during standing up in patients with unilateral and bilateral total knee arthroplasty. Acta Orthop Traumatol Turc. 2012;46(5):367-72. — View Citation

Vala CH, Kärrholm J, Kanis JA, Johansson H, Sten S, Sundh V, Karlsson M, Lorentzon M, Mellström D. Risk for hip fracture before and after total knee replacement in Sweden. Osteoporos Int. 2020 May;31(5):887-895. doi: 10.1007/s00198-019-05241-x. Epub 2019 — View Citation

Zora H, Güngör HR, Bayrak G, Savkin R, Büker N. Does mini-midvastus approach have an advantageous effect on rapid recovery protocols over medial parapatellar approach in total knee arthroplasty? Jt Dis Relat Surg. 2020;31(3):571-581. doi: 10.5606/ehc.2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall risk evaluation	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
Primary	Balance evaluation	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	Western Ontario and McMaster Universities Osteoarthritis Index score	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
Secondary	Quality of life measure	Patients' quality of life were evaluated with Short Form-12 for seconder outcome. Higher scores indicates better quality of life.	3 months
Secondary	Sit-to-stand test	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
Secondary	9-step stair climbing test	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
Secondary	40 m fast-paced walk test	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