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Completed

NCT Number: NCT07364812

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

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.

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Key information

Conditions

Arthroplasty Replacement, Knee Arthritis Gonarthrosis; Primary Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

On the day of surgery, patients were examined in their preoperative beds while in the supine position, and knee flexion and extension were recorded. After the capsulotomy, the distal femoral cartilage surface defects were photographed. Additionally, after prosthetic implantation, photos of the prostheses were taken. After the surgery was completed and dressing was applied, the patient was asked to perform knee flexion and extension while lying in the supine position, and a photo was taken.

After the surgery, when the patient was cooperative and open to communication, they were visited and informed that intraoperative photos were available and could be shown if desired. Patients who wanted to see the photos were included in the study, while those who declined formed the control group. Patients were shown the defect in the cartilage of their knee and informed that after the prostheses were implanted, they would achieve full joint range of motion. It was advised that they mobilize more safely during postoperative rehabilitation.

Pre-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 again recorded.

Assessment and Data Collection: Preoperative VAS, Oxford Knee Score, SF-12 Physical, and SF-12 Mental scores were obtained from patients after admission. These same scores were repeated and 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 test, and their scores were recorded.

The collected data will be analyzed to determine the differences between the study group and the control group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. VAS (Visual Analog Scale for Pain)

    Time frame: From preop to 6 weeks

    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

  2. Oxford Knee Score (OKS)

    Time frame: From preop to 6 weeks

    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

  3. SF-12 Physical, and SF-12 Mental scores

    Time frame: From preop to 6 weeks

    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:

    • 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

    • 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

  4. Timed Up and Go (TUG) test

    Time frame: through study completion, an average of 6 week

    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

  5. Stair Climb Test (SCT)

    Time frame: through study completion, an average of 6 week

    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

  6. 6-minute walk tests

    Time frame: through study completion, an average of 6 week

    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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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