A study evaluating the functional improvement in knee osteoarthritic patients undergoing two different techniques of Total Knee Replacement surgery

Randomised control trial: Evaluating the clinical outcomes of mechanical alignment using gap balancing and kinematic alignment using measured resection in TKR - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073412

Enrollment

140

Registered

2024-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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: Total Knee Replacement using kinematic alignment with measured resection: Surgical method of managing advance osteoarthritis of knee in which the native alignment of the individuals kne

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with advanced knee osteoarthritis deemed suitable candidates for total knee replacement (TKR). Age 18 years or older. Willingness and ability to provide informed consent for participation in the study. Patients scheduled to undergo primary TKR. Ability to comply with the follow-up schedule and study procedures. Adequate cognitive and physical capacity to complete study assessments and follow instructions.

Exclusion criteria

Exclusion criteria: History of significant knee trauma resulting in deformity or instability. Diagnosis of inflammatory arthritis affecting the knee joint (e.g., rheumatoid arthritis, psoriatic arthritis). Previous knee surgeries including partial or total knee replacements, osteotomies, or ligament reconstructions. Presence of significant comorbidities that may affect surgical outcomes or compliance with study procedures. Contraindications to TKR surgery as determined by the treating orthopedic surgeon. Inability or unwillingness to provide informed consent for study participation. Pregnant or breastfeeding women. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety or scientific integrity of the study or the well-being of the participant.

Design outcomes

Primary

Measure	Time frame
Clinical outcomes will be assessed using various validated measures, including the Oxford Knee Score, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analog Scale (VAS) for pain and functional improvement.Timepoint: The patients will be evaluated by followup on 6 weeks , 3 months , 6 months and 1 yearafter surgery	—

Secondary

Measure	Time frame
Radiographic measurement of alignment angles, implant positioning, & assessment of component fit.Timepoint: The patients will be evaluated by followup on 6 weeks , 3 months , 6 months & 1 year after surgery	—

Countries

India

Contacts

Public ContactSaurabh Sharma

Armed Forces Medical College

nidhinjose10491@gmail.com9746609301

Outcome results

None listed

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