Ligament Tension Measurement in Knee Arthroplasty

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

Study Overview

• Status: Recruiting
• Conditions: Knee Arthropathy
• Intervention / Treatment: Device: A gap plate with the function of knee joint pressure detection

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Zhihong Xu, Doctor; Phone Number: 86 13912988032; Email: xuzhihongjoint@hotmail.com
• Study Contact Backup: Name: Zhengyuan Bao, Doctor; Phone Number: 86 18013860719; Email: brandonbao@link.cuhk.edu.hk

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Zhihong Xu; Phone Number: 13912988032; Email: xuzhihongjoint@hotmail.com
      • Principal Investigator: Zhihong Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population are those receiving primary knee arthroplasty

Description

Inclusion Criteria:

• Patients receiving primary knee arthroplasty

Exclusion Criteria:

• Patients having had a surgery history of the ipsilateral knee

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ligament tension measurement group; All participants will receive ligament tension measurement by the tension device during operation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ligament tension	Measure the medial and lateral ligament tension of the operative knee at different flexion angle	During operation
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
Post-operative knee function	Assess the knee function using AKS scale at the 3rd day post-operation	The 3rd day after operation
Post-operative knee function	Assess the knee function using AKS scale at the 6th week post-operation	The 6th week after operation
Post-operative knee function	Assess the knee function using AKS scale at the 3rd month post-operation	The 3rd month after operation
Post-operative knee function	Assess the knee function using AKS scale at the 12th month post-operation	The 12th month after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative infection test	Include C-reactive protein (CRP)	1day before operation
Pre-operative infection test	Include Erythrocyte Sedimentation Rate (ESR)	1day before operation
Pre-operative infection test	Include white blood cell	1day before operation
Post-operative infection test	Include CRP	The 1st day after operation
Post-operative infection test	Include ESR	The 1st day after operation
Post-operative infection test	Include white blood cell	The 1st day after operation

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Principal Investigator: Zhihong Xu, Doctor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ligament tension, knee arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2022-LCYJ-MS-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available by consulting the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No