Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial

Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial

Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. T...

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Published in:Current controlled trials in cardiovascular medicine Vol. 24; no. 1; p. 256
Main Authors: Siren, Juuso, Rämö, Lasse, Rantasalo, Mikko, Komulainen, Olli, Skants, Noora, Reito, Aleksi, Kosola, Jussi, Lindahl, Jan
Format: Journal Article
Language:English
Published: England BioMed Central Ltd 05-04-2023
BioMed Central
BMC
Subjects:
Activity monitoring
Arthritis
Arthroplasty, Replacement, Knee - adverse effects
Arthroplasty, Replacement, Knee - methods
Care and treatment
Cartilage
Clinical trials
Comparative analysis
High tibial osteotomy
Humans
Intention to treat
Joint replacement surgery
Knee
Knee Joint - diagnostic imaging
Knee Joint - surgery
Knee osteoarthritis
Ligaments
Osteoarthritis
Osteoarthritis, Knee - diagnostic imaging
Osteoarthritis, Knee - surgery
Osteotomy
Osteotomy - adverse effects
Osteotomy - methods
Outpatient care facilities
Pain - etiology
Patients
Prospective Studies
Randomized Controlled Trials as Topic
Retrospective Studies
Study Protocol
Superiority trial
Surgeons
Surgical techniques
Tendons
Treatment Outcome
Unicompartmental knee arthroplasty
Finland
United States > US
Knee osteoarthritis
Intention to treat
Unicompartmental knee arthroplasty
Activity monitoring
High tibial osteotomy
Superiority trial
Randomized controlled trial
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Abstract Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. We will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III-IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45-65 years of age. Our primary outcome will be KOOS at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS at 12 months. The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications. ClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022.
AbstractList Abstract Background Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients’ physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients.MethodsWe will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III–IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45–65 years of age. Our primary outcome will be KOOS5 at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS5 at 12 months.Ethics and disseminationThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications.Trial registrationClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022.
Background Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. Methods We will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III-IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45-65 years of age. Our primary outcome will be KOOS.sub.5 at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS.sub.5 at 12 months. Ethics and dissemination The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications. Trial registration ClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022. Keywords: High tibial osteotomy, Unicompartmental knee arthroplasty, Intention to treat, Superiority trial, Knee osteoarthritis, Activity monitoring, Randomized controlled trial
Abstract Background Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients’ physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. Methods We will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III–IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45–65 years of age. Our primary outcome will be KOOS5 at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS5 at 12 months. Ethics and dissemination The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications. Trial registration ClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022.
Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. We will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III-IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45-65 years of age. Our primary outcome will be KOOS.sub.5 at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS.sub.5 at 12 months.
Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. We will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III-IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45-65 years of age. Our primary outcome will be KOOS at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS at 12 months. The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications. ClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022.
BACKGROUNDMedial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative treatment, unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are possible surgical treatment options for this condition. There is a paucity of high-quality evidence in the literature comparing objective and subjective outcomes of these procedures. Also, there is no common agreement on whether these procedures provide comparable results in late-stage medial knee OA patients. METHODSWe will perform a prospective randomized controlled trial comparing HTO and UKA in patients with late-stage medial knee OA. 100 patients with isolated medial knee OA (KL III-IV) are assigned to either UKA (n = 50) or HTO (n = 50) procedure in patients 45-65 years of age. Our primary outcome will be KOOS5 at one year postoperatively. Secondary outcomes include OARSI physical assessment, length of stay, wearable activity watch, radiographs (OA progression according to Kellgren-Lawrence classification), patient-reported outcomes (KOOS subscales, pain visual analog scale [VAS], Lysholm, and Oxford knee scores), and adverse events (conversion to total knee arthroplasty, surgery-related complications, need for revision surgery) outcomes. Our hypothesis is that neither of the interventions is superior as measured with KOOS5 at 12 months. ETHICS AND DISSEMINATIONThe institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings through peer-reviewed publications. TRIAL REGISTRATIONClinicalTrials.gov/TooloH NCT05442242. Registered on 7/1/2022.
ArticleNumber 256
Audience Academic
Author Kosola, Jussi
Skants, Noora
Lindahl, Jan
Rantasalo, Mikko
Rämö, Lasse
Reito, Aleksi
Siren, Juuso
Komulainen, Olli
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  organization: Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland. juuso.siren@hus.fi
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  givenname: Lasse
  surname: Rämö
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  organization: Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland
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  givenname: Mikko
  surname: Rantasalo
  fullname: Rantasalo, Mikko
  organization: Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland
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  surname: Kosola
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  givenname: Jan
  surname: Lindahl
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CitedBy_id crossref_primary_10_1111_iwj_14773
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Issue 1
Keywords Knee osteoarthritis
Intention to treat
Unicompartmental knee arthroplasty
Activity monitoring
High tibial osteotomy
Superiority trial
Randomized controlled trial
Language English
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Snippet Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative...
Background Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed...
Abstract Background Medial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients’ physical activity. After failed...
BACKGROUNDMedial knee osteoarthritis (OA) is a common health problem resulting in knee pain and limiting patients' physical activity. After failed conservative...
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StartPage 256
SubjectTerms Activity monitoring
Arthritis
Arthroplasty, Replacement, Knee - adverse effects
Arthroplasty, Replacement, Knee - methods
Care and treatment
Cartilage
Clinical trials
Comparative analysis
High tibial osteotomy
Humans
Intention to treat
Joint replacement surgery
Knee
Knee Joint - diagnostic imaging
Knee Joint - surgery
Knee osteoarthritis
Ligaments
Osteoarthritis
Osteoarthritis, Knee - diagnostic imaging
Osteoarthritis, Knee - surgery
Osteotomy
Osteotomy - adverse effects
Osteotomy - methods
Outpatient care facilities
Pain - etiology
Patients
Prospective Studies
Randomized Controlled Trials as Topic
Retrospective Studies
Study Protocol
Superiority trial
Surgeons
Surgical techniques
Tendons
Treatment Outcome
Unicompartmental knee arthroplasty
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Title Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial
URI https://www.ncbi.nlm.nih.gov/pubmed/37016454
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