Effect of RO On GB During TKR Severe Varus Deformity

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03065738
• Other study ID #: Alaa Safwat Taha
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2017
• Last updated: March 9, 2017
• Start date: January 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2017
• Source: Assiut University
• Contact: Alaa Safwat, Msc
• Phone: 002-01067655744
• Email: alaasafwat84[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Genu Varum
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• tibial reduction osteotomy in total knee replacement
reduction osteotomy :downsizing of tibial tray with lateralization

Locations

Country	Name	City	State
Egypt	Assiut University School of medicine Vice Dean for Research and Post-Graduate Studies	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HKA angle	standing A.P radiograph	immediate post operative
Secondary	functional outcome by knee society score	by knee society score	one year follow up