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

NCT04796519 | Completed

• 1 other identifier: Balance, Fall risk after TKA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthropathy

Keywords

fall risk; balance; total knee arthroplasty; function

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Western Ontario and McMaster Universities Osteoarthritis Index score

  3 months

• Quality of life measure

  3 months

• Sit-to-stand test

  3 months

• 9-step stair climbing test

  3 months

• 40 m fast-paced walk test

  3 months

Study Arms (2)

Unilateral TKA

EXPERIMENTAL

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

Bilateral TKA

EXPERIMENTAL

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

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

Surgical procedure

Bilateral TKA; Unilateral TKA

Eligibility Criteria

• Age: 46 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32962591 RESULT

• 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.

  PMID: 31832694 RESULT

• 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.

  PMID: 23268822 RESULT

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Erman Tütüncüler, Dr.

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 15, 2021
• Study Start: April 10, 2019
• Primary Completion: July 1, 2020
• Study Completion: October 10, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)