- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05183750
Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention.
High tibial osteotomy (HTO) have shown good clinical results in restoring lower extremity alignment, reducing pain, and improving knee function in patients with moderate-to-severe knee osteoarthritis and genu varum deformity.
The aim of this study is to evaluate the relation between correction of the malalignment of the knee and ankle pain and orientation in patient of medial compartment knee osteoarthritis using high tibial osteotomy by recent reports concerning the indications, functional outcomes and complication.
Study Overview
Status
Intervention / Treatment
Detailed Description
Knee osteoarthritis (OA) is highly prevalent worldwide. It is a leading cause of musculoskeletal disability and associated with activity limitation, working disability and reduced quality of life.
Osteoarthritis can affect any synovial joint in the body, however it occurs most often in weight-bearing joints, with the knee being one of the most commonly affected. Progressive loss of hyaline articular cartilage is often considered the hallmark of the disease. Within the tibiofemoral joint; articular cartilage degradation is most prevalent in the medial compartment.
Changes in demographics and physical activities of the young population have increased the number of patients with medial unicompartmental knee osteoarthritis (OA) requiring surgical intervention.
High tibial osteotomy (HTO) have shown good clinical results in restoring lower extremity alignment, reducing pain, and improving knee function in patients with moderate-to-severe knee osteoarthritis and genu varum deformity.
Prior to the development of total knee arthroplasty (TKA) as a reliable procedure in the 1980s, high tibial osteotomy (HTO) was the most common surgical treatment for varus gonarthrosis.
HTO may influence the alignment and function of the ankle joint. In the case of greater varus deformity where the preoperative talar tilt was increased medial to the ankle or the postoperative correction angle was large, the incidence of arthritis in the ankle joint rose Therefore, it is possible for realignment procedures in the knee HTO to affect ankle joint alignment and ankle symptoms.
Assessment of change in the weight-bearing-line (WBL) ratio of the ankle joints would provide a theoretical basis for post-operative ankle joint pain and osteoarthritis progression after knee arthroplasty or HTO.
The aim of this study is to evaluate the relation between correction of the malalignment of the knee and ankle pain and orientation in patient of medial compartment knee osteoarthritis using high tibial osteotomy by recent reports concerning the indications, functional outcomes and complication .
So this study aimed to investigate the change in the weight-bearing-line (WBL) ratio of the ankle joint and ankle joint line orientation after HTO in patients with genu varum deformity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sohag, Egypt, 82511
- Sohag univeristy- Faculty of medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Symptomatic medial unicompartment knee arthritis
- Active patients younger than 55 years
- Good range of motion (ROM) .
- Intact lateral compartment
Exclusion Criteria:
- Combined medial and lateral arthrosis.
- Markedly decreased knee range of motion (arc of motion 10°).
- Ligamentous instability.
- Severe joint destruction (≥Ahlback grade III).
- ≥55 years of age.
- Advanced patellofemoral arthritis.
- Rheumatoid arthritis.
- Structural lower extremity deformities.
- Previous operation at knee joint.
Study Plan
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 |
|---|---|
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Other: Adult with isolated medial compartmental knee osteoarthtitis
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Opening wedge high tibial osteotomy will be done according to the measurement preoperatively and fixation will be by plate and screws.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ankle pain (visual analogue score)
Time Frame: 1year post operative follow up
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The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain.
Scores represents a continuum between no pain 0 and worst pain 10.
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1year post operative follow up
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Coronal alignment of the ankle
Time Frame: 1year post operative follow up
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Tibial plafond inclination (TPI) (2) Talar inclination (TI) (3) Talar tilt (TT)and (4) Lateral distal tibial angle (LDTA)
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1year post operative follow up
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coronal plane correction
Time Frame: 1year post operative follow up
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hip-knee-ankle (HKA) angle, medial proximal tibial angle (MPTA), and knee-tibial plafond angle (KTPA)
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1year post operative follow up
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kijowski R, Blankenbaker D, Stanton P, Fine J, De Smet A. Arthroscopic validation of radiographic grading scales of osteoarthritis of the tibiofemoral joint. AJR Am J Roentgenol. 2006 Sep;187(3):794-9. doi: 10.2214/AJR.05.1123.
- Lee JH, Jeong BO. Radiologic changes of ankle joint after total knee arthroplasty. Foot Ankle Int. 2012 Dec;33(12):1087-92. doi: 10.3113/FAI.2012.1087.
- Ducat A, Sariali E, Lebel B, Mertl P, Hernigou P, Flecher X, Zayni R, Bonnin M, Jalil R, Amzallag J, Rosset P, Servien E, Gaudot F, Judet T, Catonne Y. Posterior tibial slope changes after opening- and closing-wedge high tibial osteotomy: a comparative prospective multicenter study. Orthop Traumatol Surg Res. 2012 Feb;98(1):68-74. doi: 10.1016/j.otsr.2011.08.013. Epub 2012 Jan 12.
- Gaasbeek R, Welsing R, Barink M, Verdonschot N, van Kampen A. The influence of open and closed high tibial osteotomy on dynamic patellar tracking: a biomechanical study. Knee Surg Sports Traumatol Arthrosc. 2007 Aug;15(8):978-84. doi: 10.1007/s00167-007-0305-0. Epub 2007 May 5.
- JACKSON JP, WAUGH W. Tibial osteotomy for osteoarthritis of the knee. J Bone Joint Surg Br. 1961 Nov;43-B:746-51. doi: 10.1302/0301-620X.43B4.746. No abstract available.
- Lustig S, Scholes CJ, Costa AJ, Coolican MJ, Parker DA. Different changes in slope between the medial and lateral tibial plateau after open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2013 Jan;21(1):32-8. doi: 10.1007/s00167-012-2229-6. Epub 2012 Oct 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-12-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO
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Clinical Trials on High tibial osteotomy
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Centre of Postgraduate Medical EducationRecruitingOsteoarthritis, Knee | Patellofemoral DisorderPoland
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Martina Hansen's HospitalSouth-Eastern Norway Regional Health AuthorityCompleted
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