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

NCT ID: NCT04796519

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2020-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Arthropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Surgical procedure

Bilateral TKA

bilateral total knee arthroplasty group (BTKA) were those who had a second TKA within 12 months after initial TKA

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Surgical procedure

Interventions

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Total knee arthroplasty

Surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

46 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Erman tütüncüler

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erman Tütüncüler, Dr.

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Zora H, Gungor HR, Bayrak G, Savkin R, Buker 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.2020.76387.

Reference Type RESULT
PMID: 32962591 (View on PubMed)

Vala CH, Karrholm J, Kanis JA, Johansson H, Sten S, Sundh V, Karlsson M, Lorentzon M, Mellstrom 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 Dec 12.

Reference Type RESULT
PMID: 31832694 (View on PubMed)

Bakirhan S, Angin S, Karatosun V, Unver B, Gunal 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. doi: 10.3944/aott.2012.2684.

Reference Type RESULT
PMID: 23268822 (View on PubMed)

Other Identifiers

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Balance, Fall risk after TKA

Identifier Type: -

Identifier Source: org_study_id

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