NCT06770153

Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner

Conditions

• Knee Injuries

Interventions

Type	Name	Description
PROCEDURE	Tensor	balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique
PROCEDURE	standard	primary TKA implantation with ligament balancing without use of the tensioner

Timeline

• Start date: 2024-10-11
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-01-13
• Last updated: 2026-01-26

Locations

1 site across 1 country: Italy