Clinical trial NCT05993637: Comparison of Proprioception for HTO (High Tibial Osteotomy) and UKA (Unicompartmantal Knee Arthroplasty)
Official title: A Comparison of the Effects of High Tibial Osteotomy and Unicompartmental Knee Arthroplasty Surgeries on Proprioception Applied to Individuals With Medial Gonarthrosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Osteoarthritis
Keywords: Gonarthrosis
High Tibial Osteotomy
Unicompartmantal Knee Arthrodesis
Proprioception
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with medial gonarthrosis and undergone surgery

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Romberg Test
timeFrame: Day 1
Secondary outcomes:
measure: Knee Society Score
timeFrame: Day 1
measure: WOMAC
timeFrame: Day 1
measure: Single Leg Stance Test
timeFrame: Day 1
measure: 5-times Sit to Stand Test
timeFrame: Day 1
measure: change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec)
timeFrame: Day 1
measure: change from baseline Gait Analyzer for step time at 8 weeks (sec)
timeFrame: Day 1
measure: change from baseline Gait Analyzer for step lenght at 8 weeks (m)
timeFrame: Day 1
measure: change from baseline Gait Analyzer for cadance at 8 weeks (step/min)
timeFrame: Day 1
measure: change from baseline Gait Analyzer for symmetry at 8 weeks (%)
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ipek Yeldan Karagoz, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.
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.
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.