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

NCT05477745 | Unknown

• 1 other identifier: IIT-2022-0048
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Sagittal flexion angle; Posterior femoral offset; Cruciate-retaining total knee arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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 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

Interventions

total knee arthroplasty PROCEDURE

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 less than 4°; The group that the sagittal flexion angle of the femoral component over 4°

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Lin Du

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

Lin Du

CONTACT

86-13817371926; sato316@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: July 29, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 22, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share