NCT06512948

Brief Summary

Exploring the factors influencing postoperative functional recovery after high tibial osteotomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

January 4, 2024

Last Update Submit

July 16, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Imaging parameters

    Medial proximal tibial angle

    an average of 1 year after the surgery

  • Imaging parameters

    Opening gap

    an average of 1 year after the surgery

  • Imaging parameters

    the weight bearing line ratio

    an average of 1 year after the surgery

  • Imaging parameters

    joint line convergence angle

    an average of 1 year after the surgery

  • Imaging parameters

    Hip-knee-ankle

    an average of 1 year after the surgery

  • Imaging parameters

    opening angle

    an average of 1 year after the surgery

Secondary Outcomes (4)

  • function score

    an average of 1 year after the surgery

  • function score

    an average of 1 year after the surgery

  • function score

    an average of 1 year after the surgery

  • function score

    an average of 1 year after the surgery

Study Arms (1)

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.

Procedure: High tibial osteotomy

Interventions

Surgical treatment for patients with osteoarthritis and indications for high tibial osteotomy

Logistics regression model

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 270000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Zhang Zhao, professor

    Shandong First Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

January 4, 2024

First Posted

July 22, 2024

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations