Comparing two ways of positioning knee replacement implants and how they affect recovery, movement, and patient satisfaction after knee replacement surgery

A case-control study of clinical outcomes, functional performance, and patient satisfaction in kinematically aligned vs. mechanically aligned total knee arthroplasty using medial pivot implants

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13254958

Enrollment

Registered

2026-06-27

Start date

2025-01-01

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Outcomes of kinematic alignment versus mechanical alignment technique in patients undergoing Total Knee Arthroplasty, using medial pivot implants Musculoskeletal Diseases

Interventions

The current study is a case–control study will compare outcomes between kinematically aligned (KA) and mechanically aligned (MA) total knee arthroplasty using medial pivot implants. Patients with end-

Eligibility

Sex/Gender

All

Age

60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults between 60-80 years old 2. Patients with end stage (K-L 3,4) primary knee osteoarthritis 3. Indicated for TKA 4. Eager and able to comply with the 2-year study’s follow-up

Exclusion criteria

Exclusion criteria: 1. Severe valgus or varus deformity (>15°) 2. Previous knee surgery 3. Inflammatory joint disease affecting the knee joint 4. Neuromuscular disorder affecting gait 5. BMI > 40 kg/m²

Design outcomes

Primary

Measure	Time frame
Pain measured using Visual Analog Scale (VAS) at 6, 12, 24 month assessment;Patient recovery measured using Forgotten Joint Score for the Knee (FJS) at 6, 12, 24 month assessment;Knee pain, stiffness, and function measured using KOOS JR (knee injury and osteoarthritis outcome score for joint replacement) at 6, 12, 24 month assessment;Pain and physical function measured using Oxford Knee Score at 6, 12, 24 month assessment	—

Measure

Time frame

Pain measured using Visual Analog Scale (VAS) at 6, 12, 24 month assessment;Patient recovery measured using Forgotten Joint Score for the Knee (FJS) at 6, 12, 24 month assessment;Knee pain, stiffness, and function measured using KOOS JR (knee injury and osteoarthritis outcome score for joint replacement) at 6, 12, 24 month assessment;Pain and physical function measured using Oxford Knee Score at 6, 12, 24 month assessment

—

Secondary

Measure	Time frame
Psychological distress in patients undergoing total knee arthroplasty measured using Short Form Health Survey questionnaire at 12, 24 month assessment;Coronal limb alignment and coronal knee alignment measured using Single leg standing long leg radiographs at 12, 24 month assessment;Incidence of postoperative complications including surgical complications, implant malalignment, implant wear, and revision surgery measured using Review of clinical records and radiographic assessments at 12, 24 month assessment	—

Measure

Time frame

Psychological distress in patients undergoing total knee arthroplasty measured using Short Form Health Survey questionnaire at 12, 24 month assessment;Coronal limb alignment and coronal knee alignment measured using Single leg standing long leg radiographs at 12, 24 month assessment;Incidence of postoperative complications including surgical complications, implant malalignment, implant wear, and revision surgery measured using Review of clinical records and radiographic assessments at 12, 24 month assessment

—

Countries

Greece

Contacts

Public ContactMichail Kroustalakis

mikekroustalakis@gmail.com+30 6939400309

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026