Back to resultsEffect of RO On GB During TKR Severe Varus Deformity
Primary Purpose
Genu Varum, Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tibial reduction osteotomy in total knee replacement
Sponsored by
About this trial
This is an interventional treatment trial for Genu Varum focused on measuring reduction osteotomy, knee arthroplasty
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
Sites / Locations
- Assiut University School of medicine Vice Dean for Research and Post-Graduate StudiesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
osteoarthritis knee ,severe varus deformity
Arm Description
reduction osteotomy in total knee replacement
Outcomes
Primary Outcome Measures
HKA angle
standing A.P radiograph
Secondary Outcome Measures
functional outcome by knee society score
by knee society score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03065738
Brief Title
Effect of RO On GB During TKR Severe Varus Deformity
Official Title
Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Anticipated)
Study Completion Date
February 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genu Varum, Knee Osteoarthritis
Keywords
reduction osteotomy, knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
osteoarthritis knee ,severe varus deformity
Arm Type
Experimental
Arm Description
reduction osteotomy in total knee replacement
Intervention Type
Other
Intervention Name(s)
tibial reduction osteotomy in total knee replacement
Intervention Description
reduction osteotomy :downsizing of tibial tray with lateralization
Primary Outcome Measure Information:
Title
HKA angle
Description
standing A.P radiograph
Time Frame
immediate post operative
Secondary Outcome Measure Information:
Title
functional outcome by knee society score
Description
by knee society score
Time Frame
one year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Safwat, Msc
Phone
002-01067655744
Email
alaasafwat84@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser Khalifa, MD
Phone
002-01006134669
Email
Ykhalifa67@hotmail.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Bakr, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University School of medicine Vice Dean for Research and Post-Graduate Studies
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser Khalifa, MD
Phone
002-01005673622
Email
Ykhalifa67@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hatem Bakr, MD
Phone
002-01001010830
Email
hatem_bakr@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of RO On GB During TKR Severe Varus Deformity
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