Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.
1 other identifier
interventional
88
1 country
1
Brief Summary
Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Oct 2020
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedMay 7, 2024
May 1, 2024
3.5 years
July 6, 2020
May 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain and Function using Oxford Knee Score
this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)
at least two year follow up.
Secondary Outcomes (1)
Range of Motion and Function using the American Knee Society Score.
at least two year follow up
Study Arms (2)
Unicompartmental Knee Replacement
EXPERIMENTALHigh Tibial Osteotomy
EXPERIMENTALInterventions
Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.
Eligibility Criteria
You may qualify if:
- \- Medial compartment osteoarthritis with exposed bone on both femur and tibia.
- Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
- Full thickness and good quality lateral cartilage present
- Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
You may not qualify if:
- Require revision knee replacement surgery.
- Have rheumatoid arthritis or other inflammatory disorders.
- Are unlikely to be able to perform required clinical assessment tasks.
- Have symptomatic foot, hip or spinal pathology.
- Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
- Previously had septic arthritis.
- Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
July 6, 2020
First Posted
July 13, 2020
Study Start
October 1, 2020
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
May 7, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share