- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06512948
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
Conditions
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
Additional Relevant MeSH Terms
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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