The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Primary Endpoint
- femoral component rotation
Study Overview
Brief Summary
Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.
Detailed Description
This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications
Exclusion Criteria
- •There are surgical contraindications Varus or valgus alignment exceeds 20 degrees
Arms & Interventions
measured resection group
The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed.
Intervention: the measured resection type of total knee arthroplasty (Procedure)
gap balance group
The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed.
Intervention: the gap balance type of total knee arthroplasty (Procedure)
Outcomes
Primary Outcomes
femoral component rotation
Time Frame: 6 weeks after the surgery
The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.
Secondary Outcomes
No secondary outcomes reported
Investigators
chenyifan
arthritis clinic and research center
Peking University People's Hospital