The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Osteoarthritis, Knee Clinical Trial

Official title:

The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03358381
• Other study ID #: PKUPHJSL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: November 26, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Leyuan Chen
• Phone: 18600116051
• Email: chenleyuanqia[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• the gap balance type of total knee arthroplasty
A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.
• the measured resection type of total knee arthroplasty
A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	femoral component rotation	The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.	6 weeks after the surgery