Osteoarthritis, KneeNCT06512948
Early Surgical Effects and Influencing Factors of High Tibial Osteotomy in the Treatment of Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Shufeng Li at 1 site in China.
Trial summary
Exploring the factors influencing postoperative functional recovery after high tibial osteotomy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- High tibial osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 270000
About this study
Exploring the factors influencing postoperative functional recovery after high tibial osteotomy
Read the 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
- Conditions
- Osteoarthritis, Knee
- Being tested
- High tibial osteotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyProcedure or surgery
Surgical treatment for patients with osteoarthritis and indications for high tibial osteotomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging parameters
Medial proximal tibial angle
Measured: an average of 1 year after the surgery
Imaging parameters
Opening gap
Measured: an average of 1 year after the surgery
Imaging parameters
the weight bearing line ratio
Measured: an average of 1 year after the surgery
Imaging parameters
joint line convergence angle
Measured: an average of 1 year after the surgery
Imaging parameters
Hip-knee-ankle
Measured: an average of 1 year after the surgery
Imaging parameters
opening angle
Measured: an average of 1 year after the surgery
Secondary outcomes (4)
function score
the US Hospital for special surgery knee-rating score
Measured: an average of 1 year after the surgery
function score
American knee society knee score
Measured: an average of 1 year after the surgery
function score
Lysholm
Measured: an average of 1 year after the surgery
function score
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: an average of 1 year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shufeng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shufeng Li, Qianfoshan Hospital
- Investigators
- Zhang Zhao, professor, Study director, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512948
- Sponsor's protocol ID
- 0000-0001-6044-0655
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Surgical Effects and Influencing Factors of High Tibial Osteotomy in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06512948
- Acronym / sponsor ID
- 0000-0001-6044-0655
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Shufeng LiUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring the factors influencing postoperative functional recovery after high tibial osteotomy
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Logistics regression model | – | Procedure: High tibial osteotomyThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High tibial osteotomySurgical treatment for patients with osteoarthritis and indications for high tibial osteotomy | Procedure or surgery | Logistics regression model |
Primary outcome
Imaging parameters
Time frame: an average of 1 year after the surgery
Medial proximal tibial angle
Imaging parameters
Time frame: an average of 1 year after the surgery
Opening gap
Imaging parameters
Time frame: an average of 1 year after the surgery
the weight bearing line ratio
Imaging parameters
Time frame: an average of 1 year after the surgery
joint line convergence angle
Imaging parameters
Time frame: an average of 1 year after the surgery
Hip-knee-ankle
Imaging parameters
Time frame: an average of 1 year after the surgery
opening angle
4 secondary outcomes
function score
Time frame: an average of 1 year after the surgery
function score
Time frame: an average of 1 year after the surgery
function score
Time frame: an average of 1 year after the surgery
function score
Time frame: an average of 1 year after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Zhao, professor study director
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Shufeng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging parameters (time frame: an average of 1 year after the surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.