Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Distal femoral resection in total knee arthroplasty

• Registration Number: NCT03085121
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-04-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-13
• Primary Completion: 2019-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Male Intramedullary	Distal femoral resection in total knee arthroplasty	In this group, patients are male and femoral Intramedullary resection would be used.
Female Intramedullary	Distal femoral resection in total knee arthroplasty	In this group, patients are female and femoral Intramedullary resection would be used.
Male Extramedullary	Distal femoral resection in total knee arthroplasty	In this group, patients are male and femoral extramedullary resection would be used.
Female Extramedullary	Distal femoral resection in total knee arthroplasty	In this group, patients are female and femoral extramedullary resection would be used.

Primary Outcome Measures

Name	Time	Method
Imaging tests	pre surgery and 3, 12 months post surgery	Evaluate the X-ray changes. Measuring the hip-knee-ankle (HKA) angle by x-ray films
Assess the changes of KSS scores	pre surgery and 3, 12 months post surgery	KSS scores will be recorded.
Assess the changes of SF-36 scores	pre surgery and 3, 12 months post surgery	SF-36 scores will be recorded
Assess the changes of WOMAC scores	pre surgery and 3, 12 months post surgery	WOMAC scores will be recorded.

Secondary Outcome Measures

Name	Time	Method
deep vein thrombosis (DVT)	pre surgery and 3, 12 months post surgery	DVT was diagnosed by 3 experienced radiologists 96 according to Robinov group's criterion.
Range of knee motion	pre surgery and 3, 12 months post surgery	Range of knee motion will be recorded.

Trial Locations

Locations (1)

Zhihong Xu; 🇨🇳 Nanjing, Jiangsu, China