NCT05183750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

December 17, 2021

Last Update Submit

September 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    1year post operative follow up

  • Coronal alignment of the ankle

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

    1year post operative follow up

  • coronal plane correction

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

    1year post operative follow up

Study Arms (1)

Adult with isolated medial compartmental knee osteoarthtitis

OTHER
Procedure: High tibial osteotomy

Interventions

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

Adult with isolated medial compartmental knee osteoarthtitis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptomatic medial unicompartment knee arthritis
  • Active patients younger than 55 years
  • Good range of motion (ROM) .
  • Intact lateral compartment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag univeristy- Faculty of medicine

Sohag, 82511, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 16928947BACKGROUND
  • 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.

    PMID: 23199858BACKGROUND
  • 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.

    PMID: 22244250BACKGROUND
  • 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.

    PMID: 17483931BACKGROUND
  • 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.

    PMID: 14036496BACKGROUND
  • 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.

    PMID: 23052121BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Orthopedic and Trauma Surgery

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 11, 2022

Study Start

December 15, 2021

Primary Completion

September 10, 2025

Study Completion

September 15, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations