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Comparison of Functional Recovery Between Restricted Inverse Kinematic Alignment and Adjusted Mechanical Alignment With Robotic-assisted Unilateral Total Knee Arthroplasty.

NCT06835621 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if restricted inverse kinematic alignment total knee arthroplasty (restricted iKA TKA) improves functional recovery compared to adjusted mechanical alignment total knee arthroplasty (aMA TKA) in patients undergoing unilateral robotic-assisted total knee arthroplasty by comparing performance-based outcome, 2-minute walk test (2MWT) as a primary outcome. This trial will also assess other outcomes including satisfaction, patient-reported functional outcomes, range of motion, visual analog scale for pain and complication of both techniques. The main question aims to answer is:

In unilateral robotic-assisted total knee arthroplasty, dose Restricted iKA technique provide better postoperative performance-based outcome compared to aMA technique?

Researchers will compare restricted iKA and aMA technique to determine which technique offers better acceleration in functional recovery and patient satisfaction.

Participants will:

After randomization, participants will allocate to either restricted iKA or aMA technique for unilateral robotic-assisted total knee arthroplasty.

Attend follow-up visits for assessments of 2-minute walk test (Primary outcome), Time up and go test (TUG), VAS for pain, ROM and complete patient-reported functional outcome questionnaires regarding knee function and satisfaction at regular intervals.

Conditions

  • OA Knee
  • TKA

Interventions

PROCEDURE

Restricted inverse kinematic alignment Total Knee Arthroplasty

Restricted inverse kinematic alignment (restricted iKA) total knee arthroplasty is an alignment technique of total knee replacement surgery, aim to maintain the native coronal alignment within a HKA angle safe zone of 177° to 183°. This technique aims to 'resurface' the femur maintaining the native femoral joint line obliquity, with the flexion and extension gaps balanced by adjusting the tibial resection first. It is considered a more personalized approach because it aims to replicate the knee's pre-arthritic alignment and movement, believing that each patient's knee has a unique alignment.

PROCEDURE

Adjusted Mechanical alignment Total Knee Arthroplasty

The adjusted Mechanical Alignment (aMA) technique is an adaptation of the conventional MA technique but with undercorrection of constitutional coronal deformity, within a limit of ± 3°. The femoral resection is adjusted to preserve mild constitutional deformity and/or reduce more severe deformity while leaving the tibial component mechanically aligned. The tibial component was positioned with the aim to be perpendicular (90°) to the mechanical tibial axis.

Sponsors & Collaborators

  • Thammasat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-08-31
Completion
2028-08-31

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835621 on ClinicalTrials.gov