Ligament Tension Measurement in Knee Arthroplasty

NCT05583630 | Unknown

• 1 other identifier: 2022-LCYJ-MS-23
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To develop a new type of knee joint pressure detection device and demonstrate its feasibility
2. 2.To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension
3. 3.To explore the correlation between knee ligament tension and postoperative knee function

Conditions

Knee Arthropathy

Keywords

ligament tension, knee arthroplasty

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Pre-operative infection test

  1day before operation

• Pre-operative infection test

  1day before operation

• Pre-operative infection test

  1day before operation

• Post-operative infection test

  The 1st day after operation

• Post-operative infection test

  The 1st day after operation

Study Arms (1)

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

Interventions

A gap plate with the function of knee joint pressure detection DEVICE

A gap plate can measure knee joint pressure by tension sensor. This is a part of routine medical care.

Ligament tension measurement group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population are those receiving primary knee arthroplasty

You may qualify if:

• Patients receiving primary knee arthroplasty

You may not qualify if:

• Patients having had a surgery history of the ipsilateral knee

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Study Officials

• Zhihong Xu, Doctor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong Xu, Doctor

CONTACT

13912988032; xuzhihongjoint@hotmail.com

Zhengyuan Bao, Doctor

CONTACT

18013860719; brandonbao@link.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 18, 2022
• Study Start: October 20, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)