Effect of RO On GB During TKR Severe Varus Deformity

NCT ID: NCT03065738

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-02-01

Brief Summary

Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity

Detailed Description

Severe varus deformity with a tibio femoral angle of 15° or more as measured on full-length weight-bearing radiographs necessitates extensive release of the medial structures to gain neutral limb alignment during total knee arthroplasty (TKA). progressive releases of the medial structures are performed until medial and lateral envelopes are equally balanced. This technique, however, faces a risk of over-release and subsequent instability, ultimately resulting in the use of a thicker polyethylene insert or even a constrained-type prosthesis. Reduction osteotomy is known as a soft tissue-sparing technique for soft tissue balancing, and it is capable of reducing the amount of release required to balance the knee and of preventing over release of medial structures. Dixon et al . and Mullaji et al . proposed the effectiveness of down-sizing the tibial component in the case of knees with severe varus deformity Aim of the work: Assess the effect of reduction osteotomy on gab balancing during total knee arthroplasty for severe varus deformity -What is the amount of deformity correction achieved with reduction osteotomy during TKA in varus knees? - What is the correlation of amount of deformity correction achieved to the amount of bone osteotomized and the degree of varus deformity?

Conditions

Genu Varum; Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

osteoarthritis knee ,severe varus deformity

reduction osteotomy in total knee replacement

Group Type: EXPERIMENTAL

tibial reduction osteotomy in total knee replacement

Intervention Type: OTHER

reduction osteotomy :downsizing of tibial tray with lateralization

Interventions

tibial reduction osteotomy in total knee replacement

reduction osteotomy :downsizing of tibial tray with lateralization

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with severe varus deformity more than 15 degrees (long film-mechanical axis)
• Patients with bone defect of medial tibial condyle

Exclusion Criteria

• Patients with extra-articular deformity
• Patients with valgus deformity

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yasser E khalifa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatem Bakr, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University School of medicine Vice Dean for Research and Post-Graduate Studies

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Alaa Safwat, Msc

Role: CONTACT

alaasafwat84@yahoo.com

002-01067655744

Yasser Khalifa, MD

Role: CONTACT

Ykhalifa67@hotmail.co

002-01006134669

Facility Contacts

Yasser Khalifa, MD

Role: primary

Ykhalifa67@hotmail.com

002-01005673622

Hatem Bakr, MD

Role: backup

hatem_bakr@hotmail.com

002-01001010830

Other Identifiers

Alaa Safwat Taha

Identifier Type: -

Identifier Source: org_study_id