NCT04924049

Brief Summary

Total knee replacement (TKR) is the most effective treatment modality for the correction of knee deformities, increasing the knee functions (KF), relieving pain, and improving quality of life (QoL) of patients. According to the health statistics of the Organisation for Economic Co-operation and Development (OECD), TKR is most commonly used in Sweden (240/100,000), United States (226/100,000), and Austria (215/100,000), while this rate is estimated as 67/100,000 in Turkey (OECD, 2017). Although it has been increasingly applied in Turkey and worldwide, it is associated with postoperative pain, restricted range of motion (ROM), and reduced muscle strength, leading to prolonged recovery process and return to activities of daily living (ADLs) with impaired QoL . In addition, inadequate patient education on knee care and ADLs following TKR may result in repetitive and uncontrollable movements and complications such as severe pain and dislocation. Postoperative complications have been shown to be associated with rehospitalization and redo surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 7, 2021

Last Update Submit

June 11, 2021

Conditions

Keywords

Knee FunctionQuality of LifeSurgical NursingVideo-Assisted Education

Outcome Measures

Primary Outcomes (1)

  • Physical function will evaluate using Western Ontario and McMaster Universities Osteoarthritis Index

    It consists of a total of 24 items including pain (5 items), stiffness (2 items), and physical function (17 items). Items are rated on a five-point Likert scale as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme). The highest possible scores which can be obtained are 20 for pain, 8 for stiffness, and 68 for physical function (difficulties experienced when engaging in ADLs). The total score ranges from 0 (the best) to 96 (the worst). Higher scores indicate worse KF, while lower scores indicate better KF.

    Change from before implementation, after, 1st month and 3rd month

Secondary Outcomes (1)

  • Quality of life will evaluate using Short Form 36 Quality of Life Scale

    Change from before implementation, after, 1st month and 3rd month

Study Arms (2)

Experimental

EXPERIMENTAL

The video-assisted education group also received routine treatment and care per protocol. Additionally, this patient group watched patient education through video in the patient room before TKR. The contents of the VE were developed by the researchers and included early postoperative care for TKR (knee positioning, early mobilization, pain control, and cold application), ADLs at home (bathing and toileting, eating, sleeping, vehicle driving, housekeeping, sexual life, praying, and maintaining home safety), and gradual exercise at home (for the first 90 days after discharge).

Other: Video-assisted education

Control

NO INTERVENTION

The control group received routine treatment and care per protocol.

Interventions

Prior the study, the content and comprehensibility of the VE were evaluated by an orthopedic surgeon, two orthopedic nurses, and a physiotherapist who were not involved in the study and relevant amendments were made based on their suggestions. The preview of the final version of the VE was shown to four patients (10% of the sample) and these patients were excluded from the study. The patients were interviewed by phone calls on a weekly basis and watching VE at home, the frequency of watching VE, and doing home-based exercises were questioned.

Also known as: Education
Experimental

Eligibility Criteria

Age33 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written and verbal consent was obtained to participate in the research,
  • years and over,
  • Conscious, oriented and cooperative,
  • Able to speak and understand Turkish,
  • Not diagnosed with any psychiatric illness,
  • No known cancer disease,
  • Elective surgical intervention applied,
  • Total knee replacement applied for the first time,
  • Unilateral total knee replacement applied,
  • Patients with an Standardized Mini-Mental Test score of 23 and above were included.

You may not qualify if:

  • To research:
  • Those who do not agree to participate in the research,
  • Under 18 years old,
  • Unconscious, without orientation and cooperation,
  • Can't speak or understand Turkish,
  • Having previously been diagnosed with a psychiatric diagnosis,
  • Having a history of cancer,
  • Emergency surgical intervention applied,
  • Total knee replacement applied before,
  • Bilateral (bilateral) total knee replacement applied,
  • Patients with an Standardized Mini-Mental Test value below 23 were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Mersin University,

Mersin, Turkey/Mersin,Yenişehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Gulay Altun Ugras, Doctorate

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm \[1:1\], parallel group, prospective, randomized-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

July 1, 2018

Primary Completion

March 30, 2019

Study Completion

August 1, 2019

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations