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Clinical Trials/NCT03085121
NCT03085121
Unknown
N/A

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country100 target enrollmentApril 4, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
100
Locations
1
Primary Endpoint
Imaging tests
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2017
End Date
March 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Principal Investigator
Principal Investigator

Qing Jiang

Prof.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

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

Outcomes

Primary Outcomes

Imaging tests

Time Frame: 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

Time Frame: pre surgery and 3, 12 months post surgery

KSS scores will be recorded.

Assess the changes of SF-36 scores

Time Frame: pre surgery and 3, 12 months post surgery

SF-36 scores will be recorded

Assess the changes of WOMAC scores

Time Frame: pre surgery and 3, 12 months post surgery

WOMAC scores will be recorded.

Secondary Outcomes

  • deep vein thrombosis (DVT)(pre surgery and 3, 12 months post surgery)
  • Range of knee motion(pre surgery and 3, 12 months post surgery)

Study Sites (1)

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