NCT07545447

Brief Summary

Total knee arthroplasty (TDA) is an effective surgical method applied to reduce pain, improve joint function, and enhance quality of life in patients with advanced osteoarthritis or joint degeneration. However, it is known that surgical success is not limited to the operation itself; pre- and post-operative processes are at least as important as the surgical technique. In particular, active patient participation, early mobilization, and adherence to exercises during the rehabilitation period directly affect treatment outcomes. Patient education plays a critical role in this process. Accurate and sufficient information reduces patients' anxieties about the surgical process and increases their confidence in the recovery process. It also prevents the development of kinesiophobia (fear of movement), supporting patients in participating in physical activity more quickly and safely. Patient education can be provided through various methods. Traditional approaches include face-to-face clinical training, verbal information provided by nurses or physiotherapists, written brochures, and visual materials. While this standard clinical training is effective in conveying basic information, it may have limitations in patients' ability to recall information and adapt it to daily life. In recent years, technology-based training methods have gained increasing importance. In particular, AI-assisted video-based anatomical visualization training can present the structure of the surgery, the placement of the prosthesis, and the movement mechanism to patients in a more understandable and visual way. Such interactive and visually rich training offers advantages in terms of increasing patients' knowledge levels, reducing anxiety, and strengthening their participation in treatment. In conclusion, success after total knee arthroplasty depends not only on the surgical intervention but also on effective patient education. Comparing standard clinical training with AI-assisted visual training methods constitutes an important area of research for improving patient outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable knee-osteoarthritis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 15, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Total Knee ArthroplastyAI-Assisted TrainingAnxietyKinesiophobia

Outcome Measures

Primary Outcomes (1)

  • Anxiety Level

    State Anxiety - (STAI-I): The State-Trait Anxiety Inventory (STAI), developed by Spielberger and adapted into Turkish by Öner and Le Compte, will be used to assess anxiety levels. The STAI consists of 40 items and two subscales: State Anxiety and Trait Anxiety. In this study, the State Anxiety subscale will be used to measure participants' current anxiety levels. The State Anxiety subscale is a 4-point Likert-type scale ranging from 1 (not at all) to 4 (completely). Higher scores indicate higher levels of anxiety. The scale includes both positively and negatively worded items, which are reverse-scored accordingly. A constant value of 50 is added to the total score to obtain the final score.

    postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14

Secondary Outcomes (1)

  • Kinesiophobia Level

    Kinesiophobia will be evaluated using a validated kinesiophobia scale at three time points: postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14

Study Arms (3)

Standard Clinical Education

ACTIVE COMPARATOR

Participants in this arm will receive standard clinical education as part of routine care. This includes face-to-face verbal education provided by healthcare professionals, written informational materials, and conventional preoperative and postoperative counseling regarding total knee arthroplasty and rehabilitation exercises.

Behavioral: Standard Clinical Education

Video-Supported Education

ACTIVE COMPARATOR

Participants in this arm will receive standard clinical education combined with structured video-supported educational content. The videos will demonstrate the surgical procedure, prosthesis function, and postoperative rehabilitation exercises in a visual format to enhance understanding and retention of information.

Behavioral: Video-Supported Education

AI-Assisted Anatomical Visualization Training

EXPERIMENTAL

Participants in this arm will receive standard clinical education in addition to AI-assisted anatomical visualization training. This intervention uses artificial intelligence-supported interactive video content to provide enhanced anatomical visualization of the knee joint, prosthesis placement, and functional movement. The aim is to improve patient understanding, reduce anxiety, and decrease kinesiophobia related to total knee arthroplasty.

Behavioral: AI-Assisted Anatomical Visualization Training

Interventions

Participants receive routine preoperative and postoperative education including verbal counseling by healthcare professionals, written informational materials, and standard physiotherapy guidance regarding total knee arthroplasty and rehabilitation exercises.

Standard Clinical Education

Participants receive standard clinical education combined with structured educational videos demonstrating total knee arthroplasty procedure, prosthesis function, and rehabilitation exercises to improve patient understanding and information retention.

Video-Supported Education

Participants receive standard clinical education in addition to AI-assisted anatomical visualization training using interactive video-based content. This intervention provides enhanced visualization of knee joint anatomy, prosthesis placement, and postoperative functional movement to improve understanding and reduce anxiety and kinesiophobia.

AI-Assisted Anatomical Visualization Training

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 55 years and older
  • Patients scheduled for elective total knee arthroplasty due to knee osteoarthritis
  • Able to understand and communicate in Turkish
  • Willing to participate in the study and provide written informed consent
  • No prior total knee arthroplasty on the study knee
  • Cognitively able to complete questionnaires and follow study procedures

You may not qualify if:

  • Patients scheduled for revision total knee arthroplasty
  • Patients with active infection
  • Presence of severe neurological or psychiatric disease (conditions that would prevent reliable application of scales)
  • Severe visual or hearing loss
  • Diagnosed dementia or cognitive impairment
  • Individuals who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeAnxiety DisordersKinesiophobia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMental DisordersPhobic Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is designed as a three-arm parallel-group randomized controlled trial. Participants will be randomly assigned to one of three groups: standard clinical education, video-supported education, or AI-assisted anatomical visualization training. Each group will receive its assigned intervention independently, without crossover between groups. Outcomes will be compared between groups to evaluate the effectiveness of different educational approaches on anxiety and kinesiophobia in patients undergoing total knee arthroplasty.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Munzur University

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share