Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03085121
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 34.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: Distal femoral resection in total knee arthroplasty	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Femoral Extramedullary and Intramedullary Alignment Systems in Total Knee Arthroplasty
• Actual Study Start Date: Apr 4, 2017
• Anticipated Primary Completion Date: Mar 1, 2019
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. Assess the changes of KSS scores [pre surgery and 3, 12 months post surgery]

   KSS scores will be recorded.

3. Assess the changes of SF-36 scores [pre surgery and 3, 12 months post surgery]

   SF-36 scores will be recorded

4. Assess the changes of WOMAC scores [pre surgery and 3, 12 months post surgery]

   WOMAC scores will be recorded.

Secondary Outcome Measures

1. 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.

2. Range of knee motion [pre surgery and 3, 12 months post surgery]

   Range of knee motion will be recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhihong Xu	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Qing Jiang, Prof., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT03085121
• Other Study ID Numbers: SUIWAIXZH
• First Posted: Mar 21, 2017
• Last Update Posted: Apr 13, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qing Jiang, Prof., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: extramedullary; intramedullary; total knee arthroplasty (TKA)
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 13, 2018