NCT03085121

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

March 6, 2017

Last Update Submit

April 11, 2018

Conditions

Knee Osteoarthritis

Keywords

extramedullaryintramedullarytotal knee arthroplasty (TKA)

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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 Arms (4)

Male Extramedullary

EXPERIMENTAL

In this group, patients are male and femoral extramedullary resection would be used.

Procedure: Distal femoral resection in total knee arthroplasty

Female Extramedullary

EXPERIMENTAL

In this group, patients are female and femoral extramedullary resection would be used.

Procedure: Distal femoral resection in total knee arthroplasty

Male Intramedullary

ACTIVE COMPARATOR

In this group, patients are male and femoral Intramedullary resection would be used.

Procedure: Distal femoral resection in total knee arthroplasty

Female Intramedullary

ACTIVE COMPARATOR

In this group, patients are female and femoral Intramedullary resection would be used.

Procedure: Distal femoral resection in total knee arthroplasty

Interventions

Distal femoral resection in total knee arthroplastyPROCEDURE

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

Female ExtramedullaryFemale IntramedullaryMale ExtramedullaryMale Intramedullary

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Varus knee; degrees of extra articular deformity \< 15°; Knee Osteoarthritis; Straight limited \< 30°; range of knee flexion \> 90°; No hip abnormalities

You may not qualify if:

  • Valgus knee; degrees of extra articular deformity \> 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhihong Xu

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21575792BACKGROUND

  • 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.

    PMID: 22610529BACKGROUND

  • 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.

    PMID: 24912573BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Central Study Contacts

Qing Jiang, PhD

CONTACT

+8613605192953qingj@nju.edu.cn

Zhihong Xu, PhD

CONTACT

+8613912988032xuzhihongjoint@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 21, 2017

Study Start

April 4, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

April 13, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)