Comparison of Proprioception for HTO (High Tibial Osteotomy) and UKA (Unicompartmantal Knee Arthroplasty)

August 8, 2023 updated by: Aysenur Erekdag, Istanbul University - Cerrahpasa (IUC)

A Comparison of the Effects of High Tibial Osteotomy and Unicompartmental Knee Arthroplasty Surgeries on Proprioception Applied to Individuals With Medial Gonarthrosis

Osteoarthritis of the knee (KOA), a common degenerative joint disease, affects a significant part of the world's population. Although it can hold all the compartments in the knee joint, isolated medial compartment involvement has been reported in about 85% of individuals diagnosed with KOA.

In the management of degenerative medial gonarthrosis; symptomatic relief and provide orthopaedic surgeons with the aim to slow down the progression of Total Knee Arthroplasty (TKA) unikompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) is used. In recent years, HTO and UKA have been preferred more frequently among these surgical methods due to a number of advantages they provide for patients.

As a result of the orthopedic surgeries performed, interventions are made on bone and joint structures and problems may occur in the proprioceptive inputs provided by the body. In UKA, a new joint structure is created by changing the bone structure and removing the tibial plateau, while in HTO, the existing bone structure is preserved and a positional change is created. Thus, while it is expected that the proprioceptive response to be different between the two surgeries, no studies have been found in the literature on this issue. Accordingly, the purpose of this study is to compare the effects of HTO and UKA surgeries applied to individuals diagnosed with medial gonarthrosis on the proprioception of patients and to examine the effects of HTO and UKA surgeries on patients diagnosed with medial gonarthrosis.

H0: There is no difference between the surgical methods applied when the proprioception of patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis is considered.

H1: There is a difference between the surgical methods applied when the proprioception of patients with HTO and UKA surgeries planned for individuals with medial gonarthrosis are considered.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Volunteer participants who have been diagnosed with medial gonarthrosis and have varus deformity and have undergone surgery will be included. The surgical groups will be divided into two categories: HTO and UKA. Evaluations of the participants in terms of proprioception will be made. A voluntary consent form will be obtained from the participants.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Omer Naci Ergin, Asst. Prof.
  • Phone Number: +905325051388
  • Email: omnaer@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have been diagnosed with medial gonarthrosis and undergone surgery

Description

Inclusion Criteria:

  • Undergoing surgery at the age of 50-65
  • Performing unilateral UKA or HTO surgery
  • Moderate medial knee arthrosis on pre-op X-ray
  • Presence of mild varus deformity in the pre-op period
  • Should be BMI<30

Exclusion Criteria:

  • Regular exercise at least 3 days a week, 150 minutes, moderate intensity
  • Having undergone revision surgery
  • The presence of any other orthopedic problems/problems and surgery
  • Concomitant of a common rheumatological disease
  • Presence of neurological problems/problems
  • Having visual and auditory problems at a level that prevents communication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Tibial Osteotomy
patients who were diagnosed with medial gonarthrosis and underwent HTO surgery
Other: Examination of propriception
application of the tests used in proprioception assessment to patients by a physiotherapist
Unicompartmantal Knee Arthroplasty
patients who were diagnosed with medial gonarthrosis and underwent UKA surgery
Other: Examination of propriception
application of the tests used in proprioception assessment to patients by a physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Romberg Test
Time Frame: Day 1
The patient is asked to stand in an upright position with his feet open at shoulder level and his arms free at the sides. The patient, who does not receive any support, is asked to stand first with his eyes open and then with his eyes closed. While the patient is standing still, the time until the moment when his balance is disturbed is recorded.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: Day 1
The system is divided into a knee score, which assesses only the knee joint itself, and functional scores, which assesses the patient's ability to walk and climb stairs. As a result of the dual rating system, the problem of decreasing knee scores associated with patient weakness is eliminated.
Day 1
WOMAC
Time Frame: Day 1
It is a scale that evaluates the disability associated with these conditions in hip and/or knee osteoarthritis. It consists of three parts: pain, stiffness and physical function. It contains a total of 24 substances.
Day 1
Single Leg Stance Test
Time Frame: Day 1
It is used to evaluate static posture and balance control. The patient should stand unaided on one leg from the moment when the other foot leaves the floor until the time when the foot touches the floor again or the arms leave the hips.
Day 1
5-times Sit to Stand Test
Time Frame: Day 1
It is used to assess the functional strength of the lower extremities, transitional movements, balance and the risk of falls. Participants are evaluated by sitting on a back-supported chair five times and holding it for a while while getting up.
Day 1
change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec)
Time Frame: Day 1
It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
Day 1
change from baseline Gait Analyzer for step time at 8 weeks (sec)
Time Frame: Day 1
It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
Day 1
change from baseline Gait Analyzer for step lenght at 8 weeks (m)
Time Frame: Day 1
It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
Day 1
change from baseline Gait Analyzer for cadance at 8 weeks (step/min)
Time Frame: Day 1
It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
Day 1
change from baseline Gait Analyzer for symmetry at 8 weeks (%)
Time Frame: Day 1
It is a smartphone-based application for analyzing walking parameters in real time. It can measure walking speed, step duration, step length, cadence and symmetry.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Ipek Yeldan Karagoz, Prof., Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-473945936

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Examination of propriception

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe