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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03358381

Enrollment

Registered

2017-11-30

Start date

2018-01-01

Completion date

2018-12-31

Last updated

2017-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

total knee arthroplasty, CT scan

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.

Interventions

PROCEDUREthe 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.

PROCEDUREthe 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Contacts

Primary ContactLeyuan Chen

chenleyuanqia@hotmail.com18600116051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026