NCT05583630RecruitingNot Applicable
Ligament Tension Measurement in Knee Arthroplasty
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country110 target enrollmentStarted: October 20, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Pre-operative knee function
Study Overview
Brief Summary
- 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
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients receiving primary knee arthroplasty
Exclusion Criteria
- •Patients having had a surgery history of the ipsilateral knee
Outcomes
Primary Outcomes
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 12th month after operation
Assess the knee function using AKS scale at the 12th month post-operation
Ligament tension
Time Frame: During operation
Measure the medial and lateral ligament tension of the operative knee at different flexion angle
Secondary Outcomes
- Pre-operative infection test(1day before operation)
- Post-operative infection test(The 1st day after operation)
Investigators
Xu Zhihong
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sites (1)
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