- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03065738
Effect of RO On GB During TKR Severe Varus Deformity
March 9, 2017 updated by: Yasser E khalifa, Assiut University
Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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?
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alaa Safwat, Msc
- Phone Number: 002-01067655744
- Email: alaasafwat84@yahoo.com
Study Contact Backup
- Name: Yasser Khalifa, MD
- Phone Number: 002-01006134669
- Email: Ykhalifa67@hotmail.co
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Assiut University School of medicine Vice Dean for Research and Post-Graduate Studies
-
Contact:
- Yasser Khalifa, MD
- Phone Number: 002-01005673622
- Email: Ykhalifa67@hotmail.com
-
Contact:
- Hatem Bakr, MD
- Phone Number: 002-01001010830
- Email: hatem_bakr@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
53 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: osteoarthritis knee ,severe varus deformity
reduction osteotomy in total knee replacement
|
reduction osteotomy :downsizing of tibial tray with lateralization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HKA angle
Time Frame: immediate post operative
|
standing A.P radiograph
|
immediate post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional outcome by knee society score
Time Frame: one year follow up
|
by knee society score
|
one year follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hatem Bakr, MD, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
February 27, 2017
First Posted (Actual)
February 28, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alaa Safwat Taha
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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