Clinical Outcomes Between Tibial Preservation Bone Cut and Conventional Tibial Bone Cut Following Medial UKA
Faculty of Medicine, Thammasat University
1 other identifier
interventional
100
1 country
1
Brief Summary
The mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome and survivorship. However, some studies have shown that the patients still had medial knee pain and shown worst the clinical outcome, even though the survivorship was excellent. The medial knee pain after operation was the one cause of revision. The incidence of medial knee pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local inflammation, over hanging of the tibial component and overstretching of the MCL due to the application of excessive polyethylene. Therefore, the tibia in this study was cut with under resection technique for reducing the overloading on the medial tibial plateau. The purpose of this study is to compare medial knee pain between tibial bone cut preservation technique and conventional tibial bone cut technique following mobile bearing UKA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jun 2018
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
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedAugust 31, 2021
August 1, 2021
3.2 years
June 1, 2020
August 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analog scale (VAS) for pain
pain at medial tibial plateau
2 years
Secondary Outcomes (5)
knee society score
2 years
Oxford knee score
2 years
joint forgotten score
2 years
knee injury osteoarthritis outcome score
2 years
Kujala score
2 years
Study Arms (2)
tibial preservation bone cut
EXPERIMENTALtibial preservation bone cut following mobile bearing UKA
tibial conventional bone cut
EXPERIMENTALtibial conventional bone cut following mobilebearing UKA
Interventions
tibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm.
Eligibility Criteria
You may qualify if:
- medial osteoarthritis of knee
You may not qualify if:
- posttraumatic arthritis
- gout
- Rheumatoid arthritis
- anterior cruciate ligament insufficiency
- osteonecrosis of knee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boonchana Pongcharoen
Pathum Thani, 12120, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Boonchana Pongcharoen
faculty of medicine, Thammasat university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated professor
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 5, 2020
Study Start
June 1, 2018
Primary Completion
August 1, 2021
Study Completion
November 1, 2022
Last Updated
August 31, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share