Compensation of surgical technique rotational alignment variations in total knee arthroplasty

Different femoral and tibial rotation alignment among measured resection and gap-balanced total knee arthroplasty is compensated by the soft tissue envelope resulting in similar combined knee rotation and clinical outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66642689

Enrollment

Registered

2025-11-17

Start date

2015-04-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Total Knee Arthroplasty surgical techniques in primary osteoarthritis patients Surgery

Interventions

Sixty patients were randomly assigned to one of three groups, with 20 patients in each group. A simple random sampling method was used -sealed envelopes-. All three groups underwent mechanically align

Eligibility

Sex/Gender

All

Age

55 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients with painful primary osteoarthritis who were unresponsive to nonoperative treatments and scheduled for TKA.

Exclusion criteria

Exclusion criteria: Patients with a history of femoral or tibial fractures or previous tibial or femoral osteotomy were excluded to avoid potential alterations in rotational alignment.

Design outcomes

Primary

Measure	Time frame
1. Femoral component rotation is measured using Berger’s femoral component rotation angle (BFA) on non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively and 6 months postoperatively 2. Tibial component rotation is measured using the Anatomic Tibial Angle (ATA) on non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively and 6 months postoperatively 3. Combined femoral and tibial rotation in the native knee is measured using the Transepicondylar Posterior Tibial Angle (TE_PTA) on non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively 4. Combined femoral and tibial rotation in the TKA knee is measured using the Transepicondylar Posterior Tibial Component Angle (TE_PTCA) on non-contrast-enhanced helical 2D-CT scans at 6 months postoperatively 5. Axial imaging of the femoral epicondylar axis, proximal tibial plateau, tibial tubercle, and ankle joint is performed using non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively and 6 months postoperatively 6. Distances and angles in CT images are measured using the Alma Workstation 4.2.3.0 software at 1–2 months preoperatively and 6 months postoperatively	—

Measure

Time frame

1. Femoral component rotation is measured using Berger’s femoral component rotation angle (BFA) on non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively and 6 months postoperatively 2. Tibial component rotation is measured using the Anatomic Tibial Angle (ATA) on non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively and 6 months postoperatively 3. Combined femoral and tibial rotation in the native knee is measured using the Transepicondylar Posterior Tibial Angle (TE_PTA) on non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively 4. Combined femoral and tibial rotation in the TKA knee is measured using the Transepicondylar Posterior Tibial Component Angle (TE_PTCA) on non-contrast-enhanced helical 2D-CT scans at 6 months postoperatively 5. Axial imaging of the femoral epicondylar axis, proximal tibial plateau, tibial tubercle, and ankle joint is performed using non-contrast-enhanced helical 2D-CT scans at 1–2 months preoperatively and 6 months postoperatively 6. Distances and angles in CT images are measured using the Alma Workstation 4.2.3.0 software at 1–2 months preoperatively and 6 months postoperatively

—

Secondary

Measure	Time frame
Clinical assessment using the Knee Society Score (KSS), WOMAC score at 1–2 months preoperatively and 6 months postoperatively	—

Countries

Spain

Contacts

Public ContactJose A Hernández-Hermoso

jahernandezh.germanstrias@gencat.cat+34 93497 8880

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026