Early Surgical Effects and Influencing Factors of High Tibial Osteotomy in the Treatment of Knee Osteoarthritis

July 16, 2024 updated by: Shufeng Li
Exploring the factors influencing postoperative functional recovery after high tibial osteotomy

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

A retrospective study was conducted on patients who underwent HTO at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, and the preoperative and postoperative imaging indicators [medial proximal tibial angle (MPTA), joint line intersection angle (JLCA), hip-knee-ankle angle (HKA angle), knee weight-bearing line percentage (WBL%), postoperative distraction distance, postoperative distraction angle] and knee joint function score [including the American Hospital for Special Surgery (HSS) knee score, American Knee Society score (KSS), Lysholm score, Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC), and all were included in logistic regression analysis to study the surgical effect and impact of HTO factor

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shandong
      • Jinan, Shandong, China, 270000
        • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study subjects were patients who underwent medial open HTO for KOA at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020. This article included a total of 45 patients with grade II and grade III according to the Kellgren-Lawrence arthritis classification. There were 28 cases, including 5 grade IV patients.

Description

Inclusion Criteria:

  • Medial knee OA, varus deformity is mainly in the tibia
  • Aged ≤70 years old, with higher requirements for future activities
  • Knee joint extension is limited to ≤10°, and flexion is >90°
  • Body Mass Index (BMI) ≤ 40
  • No subchondral bone wear

Exclusion Criteria:

  • There is a history of fracture or surgery of the lower limb on the operated side
  • Traumatic KOA
  • Combined with nerve, muscle or connective tissue diseases
  • Incomplete imaging data and loss of follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Logistics regression model
This article is a retrospective study, which mainly incorporates patients' preoperative and postoperative imaging parameters and demographic data into Logistics regression analysis to analyze factors that may affect the surgical effect. No interventions such as medication are involved.
Surgical treatment for patients with osteoarthritis and indications for high tibial osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging parameters
Time Frame: an average of 1 year after the surgery
Medial proximal tibial angle
an average of 1 year after the surgery
Imaging parameters
Time Frame: an average of 1 year after the surgery
Opening gap
an average of 1 year after the surgery
Imaging parameters
Time Frame: an average of 1 year after the surgery
the weight bearing line ratio
an average of 1 year after the surgery
Imaging parameters
Time Frame: an average of 1 year after the surgery
joint line convergence angle
an average of 1 year after the surgery
Imaging parameters
Time Frame: an average of 1 year after the surgery
Hip-knee-ankle
an average of 1 year after the surgery
Imaging parameters
Time Frame: an average of 1 year after the surgery
opening angle
an average of 1 year after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
function score
Time Frame: an average of 1 year after the surgery
the US Hospital for special surgery knee-rating score
an average of 1 year after the surgery
function score
Time Frame: an average of 1 year after the surgery
American knee society knee score
an average of 1 year after the surgery
function score
Time Frame: an average of 1 year after the surgery
Lysholm
an average of 1 year after the surgery
function score
Time Frame: an average of 1 year after the surgery
Western Ontario and McMaster Universities Osteoarthritis Index
an average of 1 year after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Zhang Zhao, professor, The First Affiliated Hospital of Shandong First Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 0000-0001-6044-0655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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