Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

A Comparative Study of Femoral Extramedullary and Intramedullary Alignment Systems in Total Knee Arthroplasty

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03085121

Enrollment

100

Registered

2017-03-21

Start date

2017-04-04

Completion date

2020-03-31

Last updated

2018-04-13

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

Conditions

Knee Osteoarthritis

Keywords

extramedullary, intramedullary, total knee arthroplasty (TKA)

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.

Interventions

PROCEDUREDistal femoral resection in total knee arthroplasty

EM and IM alignment systems are used to make the distal femoral cut in a random order.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactQing Jiang, PhD

qingj@nju.edu.cn+8613605192953

Backup ContactZhihong Xu, PhD

xuzhihongjoint@hotmail.com+8613912988032

Outcome results

None listed

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