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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05183750
Collaborator
(none)
20
1
1
12.5
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: High tibial osteotomy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ankle Pain and Orientation After High Tibial Osteotomy as a Treatment of Medial Compartment Knee Osteoarthritis
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Adult with isolated medial compartmental knee osteoarthtitis

Procedure: High tibial osteotomy
Opening wedge high tibial osteotomy will be done according to the measurement preoperatively and fixation will be by plate and screws.

Outcome Measures

Primary Outcome Measures

  1. Ankle pain (visual analogue score) [1year post operative follow up]

    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.

  2. Coronal alignment of the ankle [1year post operative follow up]

    Tibial plafond inclination (TPI) (2) Talar inclination (TI) (3) Talar tilt (TT)and (4) Lateral distal tibial angle (LDTA)

  3. coronal plane correction [1year post operative follow up]

    hip-knee-ankle (HKA) angle, medial proximal tibial angle (MPTA), and knee-tibial plafond angle (KTPA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag univeristy- Faculty of medicine Sohag Egypt 82511

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Lotfy Saber Mohammed, Specialist of Orthopedic and Trauma Surgery, Sohag University
ClinicalTrials.gov Identifier:
NCT05183750
Other Study ID Numbers:
  • Soh-Med-21-12-18
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022