Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

Nanjing University

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Procedure: Distal femoral resection in total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03085121

SUIWAIXZH

Details and patient eligibility

About

A prospective study will be performed to compare the clinical outcome after total knee arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an intramedullary system. The extramedullary femoral alignment system is newly designed. These two systems are used to make the distal femoral resection in 100 patients in a random order.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Varus knee; degrees of extra articular deformity < 15°; Knee Osteoarthritis; Straight limited < 30°; range of knee flexion > 90°; No hip abnormalities

Exclusion criteria

• Valgus knee; degrees of extra articular deformity > 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Male Extramedullary

Experimental group

Description:

In this group, patients are male and femoral extramedullary resection would be used.

Treatment:

Procedure: Distal femoral resection in total knee arthroplasty

Female Extramedullary

Experimental group

Description:

In this group, patients are female and femoral extramedullary resection would be used.

Treatment:

Procedure: Distal femoral resection in total knee arthroplasty

Male Intramedullary

Active Comparator group

Description:

In this group, patients are male and femoral Intramedullary resection would be used.

Treatment:

Procedure: Distal femoral resection in total knee arthroplasty

Female Intramedullary

Active Comparator group

Description:

In this group, patients are female and femoral Intramedullary resection would be used.

Treatment:

Procedure: Distal femoral resection in total knee arthroplasty