Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085121
• Other study ID #: SUIWAIXZH
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2017
• Last updated: April 11, 2018
• Start date: April 4, 2017
• Est. completion date: March 2020

Study information

• Verified date: April 2018
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Qing Jiang, PhD
• Phone: +8613605192953
• Email: qingj[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
China	Zhihong Xu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assess the changes of KSS scores	KSS scores will be recorded.	pre surgery and 3, 12 months post surgery
Primary	Assess the changes of SF-36 scores	SF-36 scores will be recorded	pre surgery and 3, 12 months post surgery
Primary	Assess the changes of WOMAC scores	WOMAC scores will be recorded.	pre surgery and 3, 12 months post surgery
Secondary	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
Secondary	Range of knee motion	Range of knee motion will be recorded.	pre surgery and 3, 12 months post surgery