Ligament Tension Measurement in Knee Arthroplasty

Knee Arthropathy Clinical Trial

Official title:

Ligament Tension Measurement in Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583630
• Other study ID #: 2022-LCYJ-MS-23
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: August 2025

Study information

• Verified date: March 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Zhihong Xu, Doctor
• Phone: 13912988032
• Email: xuzhihongjoint[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. To develop a new type of knee joint pressure detection device and demonstrate its feasibility

2. To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension

3. To explore the correlation between knee ligament tension and postoperative knee function

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients receiving primary knee arthroplasty

Exclusion Criteria:

• Patients having had a surgery history of the ipsilateral knee

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Device:
• A gap plate with the function of knee joint pressure detection
A gap plate can measure knee joint pressure by tension sensor. This is a part of routine medical care.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ligament tension	Measure the medial and lateral ligament tension of the operative knee at different flexion angle	During operation
Primary	Pre-operative knee function	Assess the knee function using AKS (The American knee society, 0~200, higher scores mean a better outcome) scale before operation	1day before operation
Primary	Post-operative knee function	Assess the knee function using AKS scale at the 3rd day post-operation	The 3rd day after operation
Primary	Post-operative knee function	Assess the knee function using AKS scale at the 6th week post-operation	The 6th week after operation
Primary	Post-operative knee function	Assess the knee function using AKS scale at the 3rd month post-operation	The 3rd month after operation
Primary	Post-operative knee function	Assess the knee function using AKS scale at the 12th month post-operation	The 12th month after operation
Secondary	Pre-operative infection test	Include C-reactive protein (CRP)	1day before operation
Secondary	Pre-operative infection test	Include Erythrocyte Sedimentation Rate (ESR)	1day before operation
Secondary	Pre-operative infection test	Include white blood cell	1day before operation
Secondary	Post-operative infection test	Include CRP	The 1st day after operation
Secondary	Post-operative infection test	Include ESR	The 1st day after operation
Secondary	Post-operative infection test	Include white blood cell	The 1st day after operation