Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Distal femoral resection in total knee arthroplasty

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Zhihong Xu
      • Contact: Zhihong Xu, Ph.D; Email: xuzhihongjoint@hotmail.com
      • Contact: Sheng Zhou, Ph.D; Email: zhousheng0719@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Male Extramedullary; In this group, patients are male and femoral extramedullary resection would be used.	Procedure: Distal femoral resection in total knee arthroplasty; EM and IM alignment systems are used to make the distal femoral cut in a random order.
Experimental: Female Extramedullary; In this group, patients are female and femoral extramedullary resection would be used.	Procedure: Distal femoral resection in total knee arthroplasty; EM and IM alignment systems are used to make the distal femoral cut in a random order.
Active Comparator: Male Intramedullary; In this group, patients are male and femoral Intramedullary resection would be used.	Procedure: Distal femoral resection in total knee arthroplasty; EM and IM alignment systems are used to make the distal femoral cut in a random order.
Active Comparator: Female Intramedullary; In this group, patients are female and femoral Intramedullary resection would be used.	Procedure: Distal femoral resection in total knee arthroplasty; EM and IM alignment systems are used to make the distal femoral cut in a random order.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General Publications

• Meding JB, Berend ME, Ritter MA, Galley MR, Malinzak RA. Intramedullary vs extramedullary femoral alignment guides: a 15-year follow-up of survivorship. J Arthroplasty. 2011 Jun;26(4):591-5. doi: 10.1016/j.arth.2010.05.008.
• Nakahara H, Matsuda S, Okazaki K, Tashiro Y, Iwamoto Y. Sagittal cutting error changes femoral anteroposterior sizing in total knee arthroplasty. Clin Orthop Relat Res. 2012 Dec;470(12):3560-5. doi: 10.1007/s11999-012-2397-1. Epub 2012 May 19.
• Kim CW, Seo SS, Kim JH, Lee HJ, Lee CR. Factors affecting the osteolysis around the components after posterior-stabilized total knee replacement arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1863-9. doi: 10.1007/s00167-014-3088-0. Epub 2014 Jun 11.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: total knee arthroplasty (TKA); intramedullary; extramedullary
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SUIWAIXZH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No