Oxford UKA and HTO Post-market Clinical Study

Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis

Detailed Description

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:

1. Pain Numerical Rating Scale (NRS)
2. SF-12 Health Survey
3. Radiographic assessment includes pre-op and post-op mechanical femorotibial angle (mFTA), patella height, patellofemoral medial and lateral articular surfaces, and displacement angle of patella
4. Range of motion
5. Adverse event rate and classification (including complication)
6. Operating time
7. Total blood loss (BRECHER formula)
8. Revision rate

Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 370

Contacts and Locations

• Study Contact: Name: Lydia Wang; Phone Number: 6116 (86)-21-22206116; Email: lydia.wang@zimmerbiomet.com

Study Locations

• China
  • Beijing, China, 110105
    • Recruiting
    • Beijing Chaoyang Emergency Medical Center
    • Contact: Ye Huang; Phone Number: 010-59632431; Email: huangyesteve@aliyun.com
    • Contact: Yebiao Wan; Phone Number: 13911735788; Email: wanyebiao66666@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patient is aged 18 to 85 years old, inclusive;

2. 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:

   • exposed bone on both the femur and tibia in the medial compartment.
   • functionally intact ACL
   • full thickness lateral cartilage (ignore osteophytes)
   • functionally normal MCL: correctable deformity (normal medial opening)
   • acceptable patellofemoral joint: normal, medial facet OA with or without bone loss, lateral facet OA without bone loss.
3. UKA or HTO procedure completed one year prior to study participation;
4. Patient provides written informed consent by signing and dating the Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent form.

Exclusion Criteria:

1. Has undergone UKA but met any of the contraindications included in the product labeling of Oxford Partial Knee system;
2. Has rheumatoid arthritis or other forms of inflammatory joint disease;
3. Uncooperative or with neurologic disorders who are incapable of following directions;
4. Has a diagnosed systemic disease that could affect his/her safety or the study outcome;
5. Anterior cruciate ligament and posterior cruciate ligament injury, collateral ligament instability;
6. Known to be pregnant;
7. Prisoner or known alcohol / drug abuser.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Unicompartmental Knee Arthroplasty (UKA); Patients who underwent primary UKA with Oxford Partial Knee with the Microplasty® instrumentation for AMOA.
High Tibial Osteotomy (HTO); Patients who underwent Open Wedge HTO for AMOA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	Intra-op, post-op 1 year and 2 year

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Ye Huang, Beijing Chaoyang Emergency Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2021
• Primary Completion (Anticipated): April 29, 2023
• Study Completion (Anticipated): December 22, 2023

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Anteromedial osteoarthritis (AMOA)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CSA2019-47K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No