Accuracy of a novel planning tool for total knee replacement

Validation of component positioning and limb alignment as determined by a novel modular, re-usable image-derived-instrumentation based planning tool for total knee arthroplasty - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058951

Enrollment

Registered

2023-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Image-derived instrumentation based pre-operative planning, using the Kne3wiz (Arthro3d, India) software platform: Pre-operative CT scans of the patients planned for total knee arthropl

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who shall undergo unilateral total knee arthroplasty for primary osteoarthritis of the knee with a varus deformity

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone prior surgery to the index knee. 2. Patients with pre-existent limb dysplasias, valgus deformity 3. Patients with secondary osteoarthritis, and/or extra-articular deformities 4. Patients with renal or hepatic failure 5. Age less than 40 years more than 90 years 6. Patients with contra-indications to undergo CT scanning

Design outcomes

Primary

Measure	Time frame
Post-operative limb alignment as measured by the hip-knee-ankle angleTimepoint: First post-operative day (one day after surgery)	—

Secondary

Measure	Time frame
Distal femoral bone resection from the lateral condyle (in millimeters)Timepoint: Day of surgery;Distal femoral bone resection from the medial condyle (in millimeters)Timepoint: Day of surgery;Femoral component positioning in the coronal plane (measured by the mechanical lateral distal femoral angle)Timepoint: First post-operative day;Femoral component positioning in the sagittal plane (measured by the femoral component flexion angle)Timepoint: First post-operative day;Femoral component positioning in the transverse plane (measured by the femoral component rotation angle)Timepoint: First post-operative day;Posterior femoral bone resection from the lateral condyle (in millimeters)Timepoint: Day of surgery;Posterior femoral bone resection from the medial condyle (in millimeters)Timepoint: Day of surgery;Proximal tibial bone resection from the lateral condyle (in millimeters)Timepoint: Day of surgery;Proximal tibial bone resection from the medial condyle (in millimeters)Timepoint: Day of surgery;Tibial component positioning in the coronal plane (measured by the mechanical medial proximal tibial angle)Timepoint: First post-operative day;Tibial component positioning in the sagittal plane (measured by the posterior tibial slope angle)Timepoint: First post-operative day	—

Measure

Time frame

Distal femoral bone resection from the lateral condyle (in millimeters)Timepoint: Day of surgery;Distal femoral bone resection from the medial condyle (in millimeters)Timepoint: Day of surgery;Femoral component positioning in the coronal plane (measured by the mechanical lateral distal femoral angle)Timepoint: First post-operative day;Femoral component positioning in the sagittal plane (measured by the femoral component flexion angle)Timepoint: First post-operative day;Femoral component positioning in the transverse plane (measured by the femoral component rotation angle)Timepoint: First post-operative day;Posterior femoral bone resection from the lateral condyle (in millimeters)Timepoint: Day of surgery;Posterior femoral bone resection from the medial condyle (in millimeters)Timepoint: Day of surgery;Proximal tibial bone resection from the lateral condyle (in millimeters)Timepoint: Day of surgery;Proximal tibial bone resection from the medial condyle (in millimeters)Timepoint: Day of surgery;Tibial component positioning in the coronal plane (measured by the mechanical medial proximal tibial angle)Timepoint: First post-operative day;Tibial component positioning in the sagittal plane (measured by the posterior tibial slope angle)Timepoint: First post-operative day

—

Countries

India

Contacts

Public ContactDr Apurve Parameswaran

Medicover hospitals

doctorapurve@gmail.com09585115242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026