An observational study in Knee Osteoarthritis, sponsored by Zimmer Biomet. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Zimmer Biomet · Observational
The purpose of this study is to compare the performance and safety of medial UKA and HTO in the treatment of AMOA in term of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome.
The purpose of this study is to compare the outcomes of medial UKA and HTO in the treatment of AMOA by investigating the performance of these 2 procedures in terms of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome, then identify factors associated with better clinical performance. It is aimed to provide evidence-based guidelines for selecting the appropriate procedure in managing AMOA in Chinese population based on the findings of this study.
The secondary endpoints will include:
Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 370 is above the median of 100 across 484 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who underwent either primary UKA with Oxford Partial Knee with the Microplasty® instrumentation or Open Wedge HTO for AMOA, and meet the inclusion criteria and do not meet any exclusion criteria will be screened to this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who diagnosed with AMOA of the knee, and have undergone Open Wedge HTO, or primary unilateral partial knee arthroplasty with Oxford Partial Knee with Microplasty® instrumentation in accordance to indications of UKA and the following radiographic assessments in the knee joint:
Exclusion Criteria:
Patients who underwent primary UKA with Oxford Partial Knee with the Microplasty® instrumentation for AMOA.
Patients who underwent Open Wedge HTO for AMOA.
Oxford Knee Score
Oxford Knee Score is a patient reported outcome measure questionnaire with a total score range from 0 (severe arthritis) to 48 (satisfactory joint function). The questionnaire contains 12 questions, each with five options scoring from 0 to 4 with 4 being the best outcome for each question.
Time frame: 2 years
Numerical Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a measure of pain intensity in adults that consists of a numeric version of the visual analog scale numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain". Respondents select a whole one number between 0 and 10, which is best representative of their pain intensity with higher scores indicating greater pain intensity.
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
SF-12 Health Survey
The Short Form-12 Health Survey (SF-12) measures generic health concepts relevant across age, disease, and treatment groups. It was designed to measure general health status from the patient's point of view and includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Two summary scores are reported from the SF-12, namely a mental component score (MCS-12) and a physical component score (PCS-12). All subscale scores were transformed to a 0 to 100 scale with the higher score indicating less dysfunction, impairment, or pain.
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Mechanical femorotibial angle (mFTA)
Mechanical femorotibial angle is a measurement that assess the mechanical alignment of the lower limb using the long-leg radiograph. It is the lesser angle intersecting the mechanical femoral axis (the line from the center of the femoral head to the knee center) and the mechanical tibial axis (the line from the knee center to the ankle center).
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Range of motion
Measurement of flexion and extension degree of the affected joint.
Time frame: Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year
Adverse event rate and classification
Summary of adverse events recorded during the study period, including complication and reoperation.
Time frame: Intra-op, post-op 1 year and 2 year
Plan to share: No
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This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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