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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05993637
Other study ID # F-473945936
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date September 2024

Study information

Verified date August 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Aysenur Erekdag, BsC
Phone +905548959013
Email aysenurerekdag@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Examination of propriception
application of the tests used in proprioception assessment to patients by a physiotherapist

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

References & Publications (6)

Cao Z, Mai X, Wang J, Feng E, Huang Y. Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. J Arthroplasty. 2018 Mar;33(3):952-959. doi: 10.1016/j.arth.2017.10.025. Epub 2017 Dec 2. — View Citation

Ghai S, Driller M, Ghai I. Effects of joint stabilizers on proprioception and stability: A systematic review and meta-analysis. Phys Ther Sport. 2017 May;25:65-75. doi: 10.1016/j.ptsp.2016.05.006. Epub 2016 May 18. — View Citation

He M, Zhong X, Li Z, Shen K, Zeng W. Progress in the treatment of knee osteoarthritis with high tibial osteotomy: a systematic review. Syst Rev. 2021 Feb 14;10(1):56. doi: 10.1186/s13643-021-01601-z. — View Citation

Johal S, Nakano N, Baxter M, Hujazi I, Pandit H, Khanduja V. Unicompartmental Knee Arthroplasty: The Past, Current Controversies, and Future Perspectives. J Knee Surg. 2018 Nov;31(10):992-998. doi: 10.1055/s-0038-1625961. Epub 2018 Mar 7. — View Citation

Santoso MB, Wu L. Unicompartmental knee arthroplasty, is it superior to high tibial osteotomy in treating unicompartmental osteoarthritis? A meta-analysis and systemic review. J Orthop Surg Res. 2017 Mar 28;12(1):50. doi: 10.1186/s13018-017-0552-9. — View Citation

Willis-Owen CA, Brust K, Alsop H, Miraldo M, Cobb JP. Unicondylar knee arthroplasty in the UK National Health Service: an analysis of candidacy, outcome and cost efficacy. Knee. 2009 Dec;16(6):473-8. doi: 10.1016/j.knee.2009.04.006. Epub 2009 May 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Romberg Test 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 Knee Society Score 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
Secondary WOMAC 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
Secondary Single Leg Stance Test 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
Secondary 5-times Sit to Stand Test 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
Secondary change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec) 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
Secondary change from baseline Gait Analyzer for step time at 8 weeks (sec) 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
Secondary change from baseline Gait Analyzer for step lenght at 8 weeks (m) 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
Secondary change from baseline Gait Analyzer for cadance at 8 weeks (step/min) 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
Secondary change from baseline Gait Analyzer for symmetry at 8 weeks (%) 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
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