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Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis

Primary Purpose

Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High tibial osteotomy
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sohag univeristy- Faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adult with isolated medial compartmental knee osteoarthtitis

Arm Description

Outcomes

Primary Outcome Measures

Ankle pain (visual analogue score)
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.
Coronal alignment of the ankle
Tibial plafond inclination (TPI) (2) Talar inclination (TI) (3) Talar tilt (TT)and (4) Lateral distal tibial angle (LDTA)
coronal plane correction
hip-knee-ankle (HKA) angle, medial proximal tibial angle (MPTA), and knee-tibial plafond angle (KTPA)

Secondary Outcome Measures

Full Information

First Posted
December 17, 2021
Last Updated
December 17, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05183750
Brief Title
Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis
Official Title
Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Investigate the Change in the Weight-bearing-line (WBL) Ratio of the Ankle Joint and Ankle Joint Line Orientation After HTO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult with isolated medial compartmental knee osteoarthtitis
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
High tibial osteotomy
Intervention Description
Opening wedge high tibial osteotomy will be done according to the measurement preoperatively and fixation will be by plate and screws.
Primary Outcome Measure Information:
Title
Ankle pain (visual analogue score)
Description
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.
Time Frame
1year post operative follow up
Title
Coronal alignment of the ankle
Description
Tibial plafond inclination (TPI) (2) Talar inclination (TI) (3) Talar tilt (TT)and (4) Lateral distal tibial angle (LDTA)
Time Frame
1year post operative follow up
Title
coronal plane correction
Description
hip-knee-ankle (HKA) angle, medial proximal tibial angle (MPTA), and knee-tibial plafond angle (KTPA)
Time Frame
1year post operative follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Lotfy Saber Mohammed, Specialist of orthopedic
Phone
00201007448784
Email
Ahmed_lotfy_post@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrahman Hafez Khalifa, Prof. of orthopedic surgery
Phone
0020932128086
Email
abdelrahman_khalifa@med.sohag.edu.eg
Facility Information:
Facility Name
Sohag univeristy- Faculty of medicine
City
Sohag
ZIP/Postal Code
82511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moustafa Ismail Ibrahim, Lecturer of surgery

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16928947
Citation
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.
Results Reference
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PubMed Identifier
23199858
Citation
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.
Results Reference
background
PubMed Identifier
22244250
Citation
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.
Results Reference
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PubMed Identifier
17483931
Citation
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.
Results Reference
background
PubMed Identifier
14036496
Citation
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.
Results Reference
background
PubMed Identifier
23052121
Citation
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.
Results Reference
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Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis

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