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Not yet recruiting NCT07650175

Balance, Fall Risk, and Gait in Women With Total Knee Arthroplasty

Observational Total Knee Arthroplasty Postmenopausal Women Quality of Life (QOL) Balance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TKA group.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty, Postmenopausal Women, Quality of Life (QOL), Balance. Basic parameters: 60 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of Balance, Fall Risk, Gait Performance, and Quality of Life in Postmenopausal Women Undergoing Total Knee Arthroplasty

Overview

Total knee arthroplasty (TKA) is a commonly performed surgical procedure aimed at reducing pain, restoring joint function, and improving quality of life, particularly among older women. Despite improvements in pain and functional outcomes following TKA, findings regarding balance, fall risk, and gait performance remain inconsistent. Impairments in these parameters may adversely affect daily activities, independence, and overall quality of life. Unlike previous studies that have primarily focused on one or two outcomes, this study will comprehensively evaluate balance, fall risk, gait performance, and quality of life in postmenopausal women who have undergone TKA. The findings are expected to provide a more holistic understanding of long-term functional outcomes following TKA and contribute to the planning of rehabilitation programs. Therefore, the aim of this study is to compare balance, fall risk, gait performance, and quality of life between postmenopausal women who have undergone TKA and healthy postmenopausal women.

Detailed description

Total knee arthroplasty (TKA) is one of the most frequently performed surgeries aimed at reducing pain, restoring limb function and alignment, enabling normal joint movement, and increasing the level of independence in daily living activities. TKA is frequently performed in women aged 65-84 years.

In recent years, advancements in surgical techniques and prosthetic technology, along with increased surgeon experience, have broadened the range of indications for this surgery. Following TKA, balance, fall risk, and walking performance in patients can negatively impact their daily living activities and quality of life, preventing the achievement of expected rehabilitation results. While reports indicate a reduction in complaints and an increase in functional level and quality of life after TKA surgery, clear conclusions regarding patients' balance, fall risk, and walking performance have not been reached. This study differs from other studies in the literature by comprehensively evaluating the effects of TKA on critical functional parameters such as balance, fall risk, walking performance, and quality of life in postmenopausal women. While most research focuses on the effect of TDA on only one or two parameters, this study will examine four key components together, providing a more holistic assessment. Evaluating these parameters, which significantly affect the success of TDA surgery, will determine the rehabilitation process and program. Furthermore, the fact that participants scored 24 points or higher on the Mini-Mental Test will increase the reliability of the results by providing a sample capable of cognitive assessment. The aim of this study is to compare the effects of TDA surgery on balance skills, gait performance, fall risk, and quality of life in postmenopausal women who have and have not undergone the procedure.

Interventions

  • Other TKA group
    having undergone TKA

Primary outcome measures

  • Single Leg Standing Test [Time frame: 1 day]
  • 30-Second Sit-to-Stand Test [Time frame: 1 day]
  • Timed Up and Walk Test [Time frame: 1 day]
  • 10-Meter Walking Test [Time frame: 1 day]
  • Oxford Knee Score [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

  • Volunteering to participate in the study.
  • Being 60 years of age or older.
  • Having a Mini Mental Test score of 24 or higher.
  • Not having undergone previous arthroplasty surgery on the knee where surgery is planned.
  • Having experienced unilateral TDA.
  • Being a postmenopausal woman

Exclusion criteria

  • Individuals whose vital signs are unstable after surgery, or who develop any major complications such as deep vein thrombosis, pulmonary embolism, wound infection, or prolonged anesthesia side effects.
  • Presence of any neurological, vestibular, visual, cardiopulmonary, auditory, or cognitive deficits that may affect measurements.
  • Individuals diagnosed with diabetes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07650175 · KBU-FTR-NC-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗