Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

NCT ID: NCT03085121

Last Updated: 2018-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Male Extramedullary

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

Group Type EXPERIMENTAL

Distal femoral resection in total knee arthroplasty

Intervention Type PROCEDURE

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

Female Extramedullary

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

Group Type EXPERIMENTAL

Distal femoral resection in total knee arthroplasty

Intervention Type PROCEDURE

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

Male Intramedullary

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

Group Type ACTIVE_COMPARATOR

Distal femoral resection in total knee arthroplasty

Intervention Type PROCEDURE

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

Female Intramedullary

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

Group Type ACTIVE_COMPARATOR

Distal femoral resection in total knee arthroplasty

Intervention Type PROCEDURE

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

Interventions

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Distal femoral resection in total knee arthroplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Qing Jiang

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhihong Xu

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qing Jiang, PhD

Role: CONTACT

+8613605192953

Zhihong Xu, PhD

Role: CONTACT

+8613912988032

Facility Contacts

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Zhihong Xu, Ph.D

Role: primary

Sheng Zhou, Ph.D

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21575792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22610529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24912573 (View on PubMed)

Other Identifiers

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SUIWAIXZH

Identifier Type: -

Identifier Source: org_study_id

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