The Effect of Intraoperative Findings Shown to the Patient on Early Postoperative Clinical Outcomes in Primary Total Knee Arthroplasty

NCT07364812 | Completed

• 1 other identifier: E.167479
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The Effect of Showing Intraoperative Cartilage Damage and Post-Implantation Range of Motion Photos to Patients on Early Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty Objective: The aim of this study is to determine the early clinical and functional effects of showing photos of intraoperative cartilage damage and range of motion after prosthetic implantation to patients who undergo Total Knee Arthroplasty as part of the treatment for advanced gonarthrosis (stage 3-4). Patients and Methods: The study was initiated at Bezmialem Vakıf University with approval from the Ethics Committee (Approval Number: E.167479) on 03.10.2024. With a 95% confidence level and 80% power (average difference of 4 units, standard deviation of 6.3), at least 40 patients per group (2 groups) are required. Data will be analyzed using IBM SPSS Statistics 22.0 software. The t-test will be used to compare the mean differences of continuous variables between groups, the Chi-square test will be used for the distribution of categorical variables between groups, and Pearson correlation coefficient will be used to analyze the relationship between continuous variables. Descriptive statistics will include mean, standard deviation, correlation coefficient (r), frequency, and percentage values. A p-value of \<0.05 will be considered statistically significant. Exclusion criteria for our study include revision total knee arthroplasty surgeries, total knee arthroplasty surgeries following high tibial osteotomy, total knee arthroplasty surgeries after unicompartmental knee arthroplasty, and surgeries with advanced deformities requiring the use of revision implants.

Conditions

Arthroplasty Replacement, Knee; Gonarthrosis; Primary

Keywords

arthroplasty; knee; gonarthrosis; effect; photograph

Outcome Measures

Primary Outcomes (6)

• VAS (Visual Analog Scale for Pain)

  What is a VAS score? VAS stands for Visual Analog Scale. It's a simple way to measure how strong a feeling or symptom is, most often pain, but it can also be used for things like fatigue, stress, or nausea. How does the VAS work? The VAS is usually shown as a straight line. One end means "no pain" (or no symptom). The other end means "worst pain imaginable" (or the worst possible symptom). The person marks a point on the line that best matches how they feel. How is it scored? The line is usually 10 cm (100 mm) long. The score is measured from the "no pain" end to the mark. This gives a number: 0 = no pain 10 (or 100) = worst pain possible

  From preop to 6 weeks

• Oxford Knee Score (OKS)

  What is the Oxford Knee Score? The Oxford Knee Score (OKS) is a questionnaire used to measure knee pain and knee function, especially in people with: Knee arthritis Knee injuries Before and after knee surgery (like knee replacement) It focuses on how knee problems affect daily life. What does the test include? 12 questions Each question asks about: Knee pain Walking Standing up Climbing stairs Night pain Daily activities The questions usually ask how things have been over the past 4 weeks. How is it scored? Each question is scored from 0 to 4: 0 = severe problems 4 = no problems Total score range: 0 to 48 How to interpret the score? 0-19 → Severe knee problems 20-29 → Moderate knee problems 30-39 → Mild knee problems 40-48 → Good knee function Higher score = better knee function and less pain Why is it used? To understand how much knee problems affect daily life To measure improvement after treatment or surgery To compare patient outcomes in research

  From preop to 6 weeks

• SF-12 Physical, and SF-12 Mental scores

  What is the SF-12? SF-12 stands for Short Form-12. It has 12 questions about how a person feels and functions in daily life. It's a shorter version of the SF-36 survey and is often used in clinics, research, and public health studies. What do P and M mean? The SF-12 produces two main scores: 1. P = Physical Component Summary (PCS) This score reflects physical health, including: Physical functioning (e.g., ability to do daily activities) Bodily pain General physical health Limitations due to physical problems Higher P (PCS) score → better physical health 2. M = Mental Component Summary (MCS) This score reflects mental and emotional health, including: Mood and emotional well-being Stress and anxiety Social functioning Limitations due to emotional problems Higher M (MCS) score → better mental health How are the scores interpreted? Scores are usually standardized so that: 50 = average (based on the general population) Above 50 = better than average Below 50 = worse than average

  From preop to 6 weeks

• Timed Up and Go (TUG) test

  What is the Timed Up and Go (TUG) test? The TUG test is a simple physical test used to measure: Mobility Balance Walking ability Risk of falling It's commonly used in clinics, hospitals, and research, especially for people with muscle, joint, or balance problems. How is the test done? The person starts sitting in a chair (with armrests). On the signal "go," the person: Stands up Walks 3 meters (about 10 feet) Turns around Walks back Sits down again The time is measured in seconds from standing up to sitting back down. Assistive devices (like a cane or walker) can be used if normally needed. How is it scored? The score is the time in seconds. Lower time = better mobility Common interpretation (may vary slightly): \< 10 seconds → Normal mobility 10-19 seconds → Good mobility, mostly independent 20-29 seconds → Mobility problems, higher fall risk ≥ 30 seconds → Severe mobility limitation, very high fall risk

  through study completion, an average of 6 week

• Stair Climb Test (SCT)

  What is the Stair Climb Test (SCT)? The Stair Climb Test is a functional performance test used to assess: Lower-limb strength Balance and coordination Mobility Ability to perform daily activities It is commonly used in people with knee or hip problems, arthritis, or after lower-limb surgery (such as knee replacement). How is the test performed? There are a few variations, but the most common method is: The person starts standing at the bottom of a staircase. On the signal "go," they: Climb a set number of stairs (often 9-12 steps) Sometimes turn around and come back down (depending on the protocol) The time is recorded in seconds. * Handrails may be used if needed * Assistive devices may be allowed depending on the test rules How is it scored? The score is the time (in seconds) needed to complete the task. Shorter time = better performance Some studies also record: Time to go up only Time to go up and down Pain or difficulty during the test

  through study completion, an average of 6 week

• 6-minute walk tests

  The 6MWT is a simple physical fitness test that measures how far a person can walk in 6 minutes. It reflects functional exercise capacity-how well someone can perform everyday physical activities. It's widely used in people with: Heart or lung conditions Muscle or joint problems (hip/knee conditions) Neurological conditions After surgery or rehabilitation How is the test performed? The person walks back and forth along a flat corridor (usually 20-30 meters long). They are instructed to walk as far as possible in 6 minutes at a safe, comfortable pace. The person may: Slow down Stop Rest (but the timer keeps running) At 6 minutes, the total distance walked is measured (in meters). * Normal walking aids may be used * Encouragement is usually standardized How is it scored? The result is the distance walked in 6 minutes (meters). Longer distance = better functional capacity

  through study completion, an average of 6 week

Study Arms (2)

Photo Group

ACTIVE COMPARATOR

Patients who want to see intraoperative photos

Behavioral: The Effect of Showing Intraoperative Cartilage Damage and Post-Implantation Range of Motion Photos to Patients on Early Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty

Control Group

PLACEBO COMPARATOR

The patients who dont want to see intraoperative photos and also after the patients in the first group are accumulated, all subsequent patients

Behavioral: The Effect of Showing Intraoperative Cartilage Damage and Post-Implantation Range of Motion Photos to Patients on Early Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty

Interventions

The Effect of Showing Intraoperative Cartilage Damage and Post-Implantation Range of Motion Photos to Patients on Early Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty BEHAVIORAL

Before discharge, usually on the second day, active knee flexion and extension were noted while the patient was in the supine position. During the postoperative 2nd and 6th-week follow-up visits, the range of motion was also recorded. Preoperative VAS, Oxford Knee Score, SF-12 Physical, and SF-12 Mental scores were obtained from patients after admission. Additionally, the same scores were re-recorded during the 6-week follow-up visit. At the 6-week follow-up, patients underwent the Timed Up and Go (TUG) test, Stair Climb Test (SCT), and 6-minute walk tests, and their scores were recorded.

Control Group; Photo Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \* patients who have undergone Total Knee Arthroplasty as part of the treatment for advanced gonarthrosis (stage 3-4)

You may not qualify if:

• Revision total knee arthroplasty surgeries
• total knee arthroplasty surgeries following high tibial osteotomy
• total knee arthroplasty surgeries following unicompartmental knee arthroplasty
• surgeries with advanced deformities requiring the use of revision implants.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Links

• Functional outcomes and length of stay with early and high-intensity rehabilitation after simultaneous bilateral total knee arthroplasty

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After the surgery, when the patient was cooperative and open to communication, they were visited and informed that intraoperative photos were taken and could be shown to them if desired. Patients who wanted to see the photos were included in the study, while those who declined formed the control group.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: January 23, 2026
• Study Start: July 4, 2024
• Primary Completion: November 29, 2024
• Study Completion: March 15, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

TU (1)