The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty

The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: total knee arthroplasty

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients were treated with primary total knee arthroplasty in Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine.

Description

Inclusion Criteria:

• The patients undertaken the primary cruciate retaining total knee arthroplasty;
• using the curiate retaining total knee arthroplasty prothesis from Biomet and Smith&Nephew;
• Complete surgery documents and radiologic data,such as standard X-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle).

Exclusion Criteria:

• The patients without standard X-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle);
• Complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The group that the sagittal flexion angle of the femoral component less than 4°; The patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component less than 4° were categorized into this group.	Procedure: total knee arthroplasty; The surgeries were performed under general anesthesia. The medial parepatellar incision was introduced during the TKA. The femoral component size was selected according to the intro-operative measurement. The osteotomy was done according to the intramedullary guide and the cutting guide. After the proximal tibial osteotomy was finished, the cruciate-retaining Total Knee System was used. The lateral rotation of the femoral component was determined by the gap-balancing technique.
The group that the sagittal flexion angle of the femoral component over 4°; The patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component over 4° were categorized into this group.	Procedure: total knee arthroplasty; The surgeries were performed under general anesthesia. The medial parepatellar incision was introduced during the TKA. The femoral component size was selected according to the intro-operative measurement. The osteotomy was done according to the intramedullary guide and the cutting guide. After the proximal tibial osteotomy was finished, the cruciate-retaining Total Knee System was used. The lateral rotation of the femoral component was determined by the gap-balancing technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior Femoral Offset	The posterior femoral offset was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex on the medial-lateral position of the X-ray examination.	1 week after the surgery
Posterior Femoral Offset Ratio	The posterior femoral offset ratio was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex, divided by the maximal thickness of the posterior condyle projecting posterior to a straight line drawn as the extension of the anterior femoral shaft contex on the medial-lateral position of the X-ray examination.	1 week after the surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 29, 2022
• Primary Completion (ANTICIPATED): August 15, 2022
• Study Completion (ANTICIPATED): August 22, 2022

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (ACTUAL): July 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Sagittal flexion angle; Posterior femoral offset; Cruciate-retaining total knee arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IIT-2022-0048

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