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

B

Bezmialem Vakif University

Status

Completed

Conditions

Arthroplasty Replacement, Knee
Gonarthrosis; Primary

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07364812
E.167479

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups, including a placebo group

Photo Group
Active Comparator group
Description:
Patients who want to see intraoperative photos
Treatment:
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 group
Description:
The patients who dont want to see intraoperative photos and also after the patients in the first group are accumulated, all subsequent patients
Treatment:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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