Knee ArthropathyNCT05583630
Ligament Tension Measurement in Knee Arthroplasty
An observational study of Knee Arthropathy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- A gap plate with the function of knee joint pressure detection
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population are those receiving primary knee arthroplasty
Who may be able to join
- Patients receiving primary knee arthroplasty
Who cannot join
- Patients having had a surgery history of the ipsilateral knee
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Zhihong Xu, 13912988032, xuzhihongjoint@hotmail.com
Zhihong Xu
About this study
- To develop a new type of knee joint pressure detection device and demonstrate its feasibility
- To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension
- To explore the correlation between knee ligament tension and postoperative knee function
- Conditions
- Knee Arthropathy
- Being tested
- A gap plate with the function of knee joint pressure detection
- Keywords
- ligament tension, knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A gap plate with the function of knee joint pressure detectionDevice
A gap plate can measure knee joint pressure by tension sensor. This is a part of routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| Ligament tension measurement group | All participants will receive ligament tension measurement by the tension device during operation Receives: Device: A gap plate with the function of knee joint pressure detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligament tension
Measure the medial and lateral ligament tension of the operative knee at different flexion angle
Measured: 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
Measured: 1day before operation
Post-operative knee function
Assess the knee function using AKS scale at the 3rd day post-operation
Measured: The 3rd day after operation
Post-operative knee function
Assess the knee function using AKS scale at the 6th week post-operation
Measured: The 6th week after operation
Post-operative knee function
Assess the knee function using AKS scale at the 3rd month post-operation
Measured: The 3rd month after operation
Post-operative knee function
Assess the knee function using AKS scale at the 12th month post-operation
Measured: The 12th month after operation
Secondary outcomes (6)
Pre-operative infection test
Include C-reactive protein (CRP)
Measured: 1day before operation
Pre-operative infection test
Include Erythrocyte Sedimentation Rate (ESR)
Measured: 1day before operation
Pre-operative infection test
Include white blood cell
Measured: 1day before operation
Post-operative infection test
Include CRP
Measured: The 1st day after operation
Post-operative infection test
Include ESR
Measured: The 1st day after operation
Post-operative infection test
Include white blood cell
Measured: The 1st day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Oct 2022
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhihong, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Zhihong Xu, Doctor, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583630
- Sponsor's protocol ID
- 2022-LCYJ-MS-23
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available by consulting the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligament Tension Measurement in Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05583630
- Acronym / sponsor ID
- 2022-LCYJ-MS-23
- Conditions
- Knee Arthropathy
- Keywords
- ligament tension, knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To develop a new type of knee joint pressure detection device and demonstrate its feasibility
- To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension
- To explore the correlation between knee ligament tension and postoperative knee function
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ligament tension measurement group | – | Device: A gap plate with the function of knee joint pressure detectionAll participants will receive ligament tension measurement by the tension device during operation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population are those receiving primary knee arthroplasty
Key inclusion criteria (1 listed)
- Patients receiving primary knee arthroplasty
Key exclusion criteria (1 listed)
- Patients having had a surgery history of the ipsilateral knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A gap plate with the function of knee joint pressure detectionA gap plate can measure knee joint pressure by tension sensor. This is a part of routine medical care. | Device | Ligament tension measurement group |
Primary outcome
Ligament tension
Time frame: During operation
Measure the medial and lateral ligament tension of the operative knee at different flexion angle
Pre-operative knee function
Time frame: 1day before operation
Assess the knee function using AKS (The American knee society, 0~200, higher scores mean a better outcome) scale before operation
Post-operative knee function
Time frame: The 3rd day after operation
Assess the knee function using AKS scale at the 3rd day post-operation
Post-operative knee function
Time frame: The 6th week after operation
Assess the knee function using AKS scale at the 6th week post-operation
Post-operative knee function
Time frame: The 3rd month after operation
Assess the knee function using AKS scale at the 3rd month post-operation
Post-operative knee function
Time frame: The 12th month after operation
Assess the knee function using AKS scale at the 12th month post-operation
6 secondary outcomes
Pre-operative infection test
Time frame: 1day before operation
Pre-operative infection test
Time frame: 1day before operation
Pre-operative infection test
Time frame: 1day before operation
Post-operative infection test
Time frame: The 1st day after operation
Post-operative infection test
Time frame: The 1st day after operation
Post-operative infection test
Time frame: The 1st day after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No. IPD will be available by consulting the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihong Xu, Doctor principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Xu, Doctor (13912988032 ext. 86, xuzhihongjoint@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ligament tension (time frame: During operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.