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Gap differences and Reliability of Digital Tensioner vs Z-retractor vs Paddle Techniques for Gap Assessment in Robotic-Assisted TKA: A Comparative Study

Gap differences and Reliability of Digital Tensioner vs Z retractor vs Paddle Techniques for Gap Assessment in Robotic Assisted TKA: A Comparative Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260521004
Enrollment
54
Registered
2026-05-21
Start date
2026-03-07
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Osteoarthritis, Knee Degenerative Joint Disease of the Knee Robotic-assisted Total Knee Arthroplasty Soft Tissue Balancing Gap Assessment Digital Tensioner Ligament Tensioning Reliability

Interventions

The paddle technique involves inserting a calibrated spacer block (paddle) into the joint space between the femoral and tibial cut surfaces. The surgeon manually distracts the joint using the paddle t
s applied force and instrument positioning, making it a manual, examiner-dependent method.,The digital tensioner is a device that applies a standardized, reproducible distraction force of 100 Newtons
Paddle techniques,Z-retractor technique,Digital Tensioner (100N)

Sponsors

Faculty of Medicine, Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with End-stage knee OA (Kellgren-Lawrence Grade 3-4) requiring total knee arthroplasty Diagnosed based on ACR criteria. 2. Age between 50 and 80 years at the time of surgery 3. Scheduled for primary robotic TKA (CORI system)

Exclusion criteria

Exclusion criteria: 1. Previous Knee Surgery: History of major knee surgery including osteotomy, ligament reconstruction, or arthroscopic procedures within 6 months prior to the operation. 2. Inflammatory Arthritis: Rheumatoid arthritis, psoriatic arthritis, or other inflammatory joint conditions. 3. Severe Deformity: Varus or Valgus deformity more than 20 degree, Flexion contracture more than 15 degree, Significant bone loss requiring augments. 4. Ligament Deficiency: Significant collateral or cruciate ligament deficiency requiring a constrained prosthesis. 5. Active Infection: Current or recent joint infection, osteomyelitis, or systemic infection. 6. Neuromuscular Disorders: Conditions affecting muscle function or proprioception that could impact assessment. 7. Inability to Cooperate: Cognitive impairment or inability to comply with the study protocol and follow-up.

Design outcomes

Primary

MeasureTime frame
the mean differences of gaps Medial and lateral joint gaps measured at 0 degree, 30 degree, 60degree, 90 degree, and 120 degree of knee flexion. different point

Secondary

MeasureTime frame
Inter-rater Reliability intraoperative time ratio,Intra-rater Reliability intraoperative time ratio,Knee Injury and Osteoarthritis Outcome Score (KOOS) pre-operatively and at 12 weeks post-operatively. score,Oxford Knee Score (OKS) pre-operatively and at 12 weeks post-operatively. score

Countries

Thailand

Contacts

Public ContactRapeepat narkbunnam

Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

mai_parma@hotmail.com024197968

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Jun 29, 2026