NCT06288100

Brief Summary

High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 15, 2024

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient

    Measure changes in tibial slope after medial opening wedge High tibial osteotomy in Skeletally mature patient with unicompartmental osteoarthitis and genuvarus knee Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year

    Measure Posterior tibial slope by X Ray in Lateral View and Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year

Study Arms (1)

Observations

number of patients, sex, age, Bodi Mass Index , Range of Motion ,type of plate \& Screws used , Degree of deformity . Digital radiography (General Electric Healthcare ) functional scores software T-tests, One-way analysis of variance.

Other: Observation

Interventions

1. Measure changes in tibial slope after medial opening wedge High tibial osteotomy in Skeletally mature patient with unicompartmental osteoarthitis and genuvarus knee 2. Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year .

Observations

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Data Collection: The study and patients were collected according to number of patients, sex, age, Bodi Mass Index , Range of Motion ,type of plate \& Screws used , Degree of deformity . Digital radiography, functional scores, software was used for statistical analysis. compare the Posterior Tibial Slope between the different Posterior Tibial Slope sides and sexes. One-way analysis of variance was used to compare the Posterior Tibial Slope between the different age groups. Posterior Tibial Slope was evaluated in all studies according to radiographic.

You may qualify if:

  • Age: 20 : 65 years
  • Genuvarus deformity
  • ° of range of motion
  • Medial uni-compartmental osteoarthritis.

You may not qualify if:

  • Posterior instability (relating to the posterior cruciate ligament)
  • Body Mass Index under 30
  • Sever Genuvarus \> 20 degree

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abdelfattah Abbas

Asyut, Egypt

Location

MeSH Terms

Conditions

Genu Varum

Interventions

Observation

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohamed Abdelfattah Abbas

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 1, 2024

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 1, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations