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Comparison of two different alignment options in simultaneous single staged Bilateral Total knee Arthroplasty

Outcomes of calipered Mechanically Aligned versus Calipered Restricted Kinematically Aligned Bilateral Total Knee Arthroplasty : A Randomized Controlled Trial - rKA versus MA-TKA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034537
Enrollment
40
Registered
2021-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: 7- Osteopathic

Interventions

Intervention1: Two different Intervention options will be received by all patients undergoing simultaneous bilateral total knee arthroplasty: Same set of patients undergoing bilateral Total knee arthr

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients posted for simultaneous single staged B/L TKA 2. More than one compartmental primary OA with pain interfering with their activities of daily living 3. Medial proximal tibial angle between 5-10 degrees varus 4. Kellgren lawrence Grade 3/4 5. American society of anaesthesiologists grade 1 and 2

Exclusion criteria

Exclusion criteria: 1. Any patient with previous knee surgery 2. Extra-articular knee deformity 3. Any spine disorder which may interfere with mobilization 4. Revision TKA cases 5. Inflammatory Arthritis 6. FFD 15 or more degrees 7. Clinically uncorrectable Valgus/Varus deformity 15 or more 8. Any previous ligament surgery/reconstruction 9. Previous history Septic Arthritis knee

Design outcomes

Primary

MeasureTime frame
Comparison of pre-operative and post-operative Oxford Knee Score (OKS) in crKA-TKA versus MA-TKA using routine instrumentationTimepoint: pre-operative- 6 months post-operative - 12 months post-operative

Secondary

MeasureTime frame
Comparison of radiological alignment parameters pre-operatively and post-operatively Timepoint: pre-operative - post-operative 2 weeks;Joint awareness and perception post-operativelyTimepoint: pre-operative- 6 months post-operative - 12 months post-operative;Patient reported outcome measures (PROMs) between the knees Timepoint: Pre-operative - post operative 6 months - post-operative 12 months;Biomechanical superiority in terms of femoral rollback - radiological confirmationTimepoint: 6 months post-operative;Pre-operative planning and intra-operative cuts co-relation of femoral and tibial cut thickness. Timepoint: pre-operative - intra-operative cuts thickness;To study any intra-operative or post-operative complicationsTimepoint: intra-operative - post-operative 6 months - post-operative 12 months;To study patient preference of one of the two alignment option using Self-administered patient satisfaction scale and VAS for patient satisfaction Timepoint: pre-operative - 6 months post operative - 12 months post-operative

Countries

India

Contacts

Public ContactArghya Kundu Choudhury

All India Institute of Medical Sciences, Rishikesh

arghyakunduchoudhury@gmail.com8013006295

Outcome results

None listed

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