C-Plate with Metal Shim for Distal Femoral Resection Effectively Controls Femoral Component Alignment in Total Knee Arthroplasty: A Non-inferiority Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260703008

Enrollment

Registered

2026-07-03

Start date

2026-07-09

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with knee osteoarthritis (OA) who have failed conservative treatment and require TKA C-plate, metal shim, total knee arthroplasty, coronal plane alignment

Interventions

The C-plate controls the bone resection in the sagittal plane by using the anterior cortex of the distal femur as the reference plane, while the MS controls the resection plane in the coronal directio

Experimental Device,Active Comparator Device

C-plate with metal shim,IM guide with metal shim

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with primary or secondary knee osteoarthritis of Kellgren Lawrence classification grade 2 or higher who undergo total knee arthroplasty at Kamphaeng Phet Hospital and are aged 45 years or older. 2. Patients who consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with a flexion contracture > 10 degrees. 2. Patients with a history of femur fracture. 3. Patients with an osteonecrotic lesion of the distal femur. 4. Patients with an avascular necrosis lesion of the femoral head. 5. Patients with a poor quality AP longstanding scanogram radiograph.

Design outcomes

Primary

Measure	Time frame
mean absolute Gamma angle deviation Postoperative 6 weeks The blinded orthopedic surgeon recorded the Gamma angle on the lateral knee radiograph in PACS	—

Secondary

Measure	Time frame
means of absolute femoral mechanical deviation angle Postoperative 6 weeks The blinded orthopedic surgeon measures the mLDFA on the long-leg standing radiograph in PACS,mean knee flexion angle postoperative 24, 48 hours and 2, 6, 18, 30 weeks The blinded orthopedic surgeon measures knee flexion using a goniometer.,mean VAS score postoperative 12, 18, 24, 48 hours The patient self-scores pain on the VAS form.,mean calculated blood loss postoperative 48 huors The Nadler formula calculates the patient's predicted blood volume in milliliters,mean Oxford Knee Score postoperative 2, 6, 18, 30 weeks The patient self-scores OKS on the form.	—

Measure

Time frame

means of absolute femoral mechanical deviation angle Postoperative 6 weeks The blinded orthopedic surgeon measures the mLDFA on the long-leg standing radiograph in PACS,mean knee flexion angle postoperative 24, 48 hours and 2, 6, 18, 30 weeks The blinded orthopedic surgeon measures knee flexion using a goniometer.,mean VAS score postoperative 12, 18, 24, 48 hours The patient self-scores pain on the VAS form.,mean calculated blood loss postoperative 48 huors The Nadler formula calculates the patient's predicted blood volume in milliliters,mean Oxford Knee Score postoperative 2, 6, 18, 30 weeks The patient self-scores OKS on the form.

—

Countries

Thailand

Contacts

Public ContactThisayapong Intangam

Kamphaeng Phet Hospital

Thisayapong@gmail.com055022000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026