Oxford UKA and HTO Post-market Clinical Study

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04518111
• Other study ID #: CSA2019-47K
• Status: Enrolling by invitation
• Start date: April 24, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 370
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis

Locations

Country	Name	City	State
China	Beijing Chaoyang Emergency Medical Center	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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