Back to resultsUnicompartmental Knee Arthroplasty vs High Tibial Osteotomy.
Primary Purpose
Knee Osteoarthritis, Knee Arthroplasty
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Unicompartmental Knee Replacement
High Tibial Osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Unicompartmental knee Replacement
Eligibility Criteria
Inclusion Criteria:
- - Medial compartment osteoarthritis with exposed bone on both femur and tibia.
- -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
- -Full thickness and good quality lateral cartilage present
- -Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
Exclusion Criteria:
- Require revision knee replacement surgery.
- Have rheumatoid arthritis or other inflammatory disorders.
- Are unlikely to be able to perform required clinical assessment tasks.
- Have symptomatic foot, hip or spinal pathology.
- Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
- Previously had septic arthritis.
- Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Unicompartmental Knee Replacement
High Tibial Osteotomy
Arm Description
Outcomes
Primary Outcome Measures
Pain and Function using Oxford Knee Score
this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)
Secondary Outcome Measures
Range of Motion and Function using the American Knee Society Score.
this will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function in which the maximum score to get is 100 and least score to get is 0 and the higher the score the better the outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04467970
Brief Title
Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.
Official Title
Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (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
Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.
Detailed Description
Although HTO for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. Furthermore, indications for UKA are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthroplasty
Keywords
Unicompartmental knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unicompartmental Knee Replacement
Arm Type
Experimental
Arm Title
High Tibial Osteotomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Unicompartmental Knee Replacement
Intervention Description
Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
Intervention Type
Procedure
Intervention Name(s)
High Tibial Osteotomy
Intervention Description
High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.
Primary Outcome Measure Information:
Title
Pain and Function using Oxford Knee Score
Description
this will be measured by using the Oxford Knee Score, a patient reported outcome questionnairewhich is A patient reported outcome measure highest score that could a patient get is 48 and means that good outcome and the lowest score to be obtained is 0 whick means poor outcome ( the higher the score,the better the outcome)
Time Frame
at least two year follow up.
Secondary Outcome Measure Information:
Title
Range of Motion and Function using the American Knee Society Score.
Description
this will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function in which the maximum score to get is 100 and least score to get is 0 and the higher the score the better the outcome.
Time Frame
at least two year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Medial compartment osteoarthritis with exposed bone on both femur and tibia.
-Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
-Full thickness and good quality lateral cartilage present
-Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2
Exclusion Criteria:
Require revision knee replacement surgery.
Have rheumatoid arthritis or other inflammatory disorders.
Are unlikely to be able to perform required clinical assessment tasks.
Have symptomatic foot, hip or spinal pathology.
Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
Previously had septic arthritis.
Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.
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