Knee OsteoarthritisNCT05993637
Comparison of Proprioception for HTO (High Tibial Osteotomy) and UKA (Unicompartmantal Knee Arthroplasty)
An observational study of Knee Osteoarthritis, run by Istanbul University - Cerrahpasa.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Examination of propriception
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with medial gonarthrosis and undergone surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Examination of propriception
- Keywords
- Gonarthrosis, High Tibial Osteotomy, Unicompartmantal Knee Arthrodesis, Proprioception
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of propriceptionOther
application of the tests used in proprioception assessment to patients by a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| High Tibial Osteotomy | patients who were diagnosed with medial gonarthrosis and underwent HTO surgery Receives: Other: Examination of propriception | |
| Unicompartmantal Knee Arthroplasty | patients who were diagnosed with medial gonarthrosis and underwent UKA surgery Receives: Other: Examination of propriception |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (9)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study startMay 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
- Investigators
- Ipek Yeldan Karagoz, Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993637
- Sponsor's protocol ID
- F-473945936
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19464898Johal 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.
PubMed 29514367Cao 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.
PubMed 29203354He 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.
PubMed 33583421Santoso 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.
PubMed 28351371Ghai 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.
PubMed 28262354
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of High Tibial Osteotomy and Unicompartmental Knee Arthroplasty Surgeries on Proprioception Applied to Individuals With Medial Gonarthrosis
- ClinicalTrials.gov ID
- NCT05993637
- Acronym / sponsor ID
- F-473945936
- Conditions
- Knee Osteoarthritis
- Keywords
- Gonarthrosis, High Tibial Osteotomy, Unicompartmantal Knee Arthrodesis, Proprioception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Tibial Osteotomy | – | Other: Examination of propriceptionpatients who were diagnosed with medial gonarthrosis and underwent HTO surgery |
| Unicompartmantal Knee Arthroplasty | – | Other: Examination of propriceptionpatients who were diagnosed with medial gonarthrosis and underwent UKA surgery |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with medial gonarthrosis and undergone surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination of propriceptionapplication of the tests used in proprioception assessment to patients by a physiotherapist | Other | High Tibial Osteotomy, Unicompartmantal Knee Arthroplasty |
Primary outcome
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.
9 secondary outcomes
Knee Society Score
Time frame: Day 1
WOMAC
Time frame: Day 1
Single Leg Stance Test
Time frame: Day 1
5-times Sit to Stand Test
Time frame: Day 1
change from baseline Gait Analyzer for walking speed at 8 weeks (m/sec)
Time frame: Day 1
change from baseline Gait Analyzer for step time at 8 weeks (sec)
Time frame: Day 1
change from baseline Gait Analyzer for step lenght at 8 weeks (m)
Time frame: Day 1
change from baseline Gait Analyzer for cadance at 8 weeks (step/min)
Time frame: Day 1
change from baseline Gait Analyzer for symmetry at 8 weeks (%)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 19464898Willis-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.
- Background: PubMed 29514367Johal 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.
- Background: PubMed 29203354Cao 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.
- Background: PubMed 33583421He 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.
- Background: PubMed 28351371Santoso 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.
- Background: PubMed 28262354Ghai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipek Yeldan Karagoz, Prof. study director
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysenur Erekdag, BsC (+905548959013, aysenurerekdag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Romberg Test (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993637, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.