Osteoarthritis, KneeNCT06158425
Constitutional Alignment in Osteoarthritic and Healthy Chinese
An observational study of Osteoarthritis, Knee, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
coronal plane alignment of the knee(CPAK) distribution of 246 cases(477 knees) of OA patients and 107 cases(214 knees) of healthy people were examined on long-leg radiographs retrospectively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- long-leg radiograph
- Type of treatment
- Surgery or procedure
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 6 Dec 2023
- 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: OA group: consecutive OA patients with knee pain who underwent primary TKA Healthy group: consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity
Who may be able to join
- OA group: Data for consecutive OA patients with knee pain who underwent primary TKA by one senior surgeon between August 2021 and July 2023 at a single institution were analyzed retrospectively.
- Healthy group: Data for consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity between January 2023 and July 2023 at the same institution were analyzed retrospectively.
Who cannot join
- OA group: prior total hip arthroplasty; obvious bony deficiency of the femur or tibia, simultaneous flexion of the knee and rotation of the leg on radiographs Healthy group: extra-articular deformity of the femur or tibia; simultaneous flexion of the knee and rotation of the leg on radiographs; poor quality image
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun
Xin Qi, Dr., +8615843073202, qixindoc@163.com
About this study
Official title: Distribution of Coronal Plane Alignment of the Knee Classification in Chinese Osteoarthritic as Well as Healthy Population
coronal plane alignment of the knee(CPAK) distribution of 246 cases(477 knees) of OA patients and 107 cases(214 knees) of healthy people were examined on long-leg radiographs retrospectively. Radiological measurements and CPAK classification on different Kellgren- Lawrence(K-L) Grade in patients with unilateral total knee arthroplasty(TKA) were compared. Clinical outcomes of CPAK type I patients performed by mechanical alignment(MA) and restricted kinematic alignment(rKA) during TKA were examined. ML algorithm including K nearest neighbors (KNN), random forest(RF), artificial neural networks (ANN), logistic regression(LR) and gradient boosting (GBDT) were established, the dependent variable was set as whether the constitutional phenotype of an arthritic knee classified as type I was type I.
Read the detailed description
Study groups and design OA group Data for consecutive OA patients with knee pain who underwent primary TKA by one senior surgeon between August 2021 and July 2023 at a single institution were analyzed retrospectively. A total of 273 patients underwent long-leg radiographs. The following 27 patients were excluded from this study: prior total hip arthroplasty, 2; obvious bony deficiency of the femur or tibia, 10; simultaneous flexion of the knee and rotation of the leg on radiographs, 15. CPAK distribution of the remaining 246 cases(unilateral, 15; bilateral, 231; totally 477 knees) was examined.
healthy group Data for consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity between January 2023 and July 2023 at the same institution were analyzed retrospectively. A total of 136 visitors were recruited. The following 18 visitors were excluded from this study: extra-articular deformity of the femur or tibia, 15; simultaneous flexion of the knee and rotation of the leg on radiographs, 13; poor quality image, 1. CPAK distribution of the remaining 107 cases(214 knees) was examined.
Radiological measurements All participants underwent standard digital long leg radiographs. The mechanical axis of the femur was marked from the centre of the femoral head to the centre of the knee. The centre of the head was marked using the concentric-circle method to identify the centre. The centre of the ankle was marked as the point on the talar dome at mid-width. The mHKA angle was the angle subtended by the mechanical axes of the femur and tibia. The LDFA was defined as the lateral angle formed between the femoral mechanical axis and the joint line of the distal femur. The MPTA was defined as the medical angle formed between the tibial mechanical axis and the joint line of the proximal tibia. Joint line convergence angle(JLCA) was the angle formed between joint orientation lines on opposite sides of the same joint[17]. All measurements were carried out by an orthopaedic fellow. A senior author undertook a subgroup analysis of 60 knees in OA group and repeated at one- week intervals to assess for inter- and intra- observer agreement.
CPAK classification of OA and healthy group aHKA was calculated based on the following formula: aHKA=MPTA-LDFA. JLO was calculated by the formula: JLO=MPTA+LDFA. With aHKA and JLO measured, patients can be matched to 9 possible CPAK alignment groups. The mean aHKA and JLO of the two groups were rounded to the nearest whole number for final allocation to a CPAK Class. CPAK limits for the definition of neutral knees was an aHKA of 0 ± 2 degrees. CPAK boundaries for a neutral JLO were defined as 180 ± 3 degrees, varus aHKA less than-2 degrees and a valgus aHKA more than+2 degrees. An apex distal JLO was less than 177°, while an apex proximal JLO was greater than 183°[9]. The OA and healthy group were categorized according to the CPAK classification, and their distribution were investigated.
- Conditions
- Osteoarthritis, Knee
- Being tested
- long-leg radiograph
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-leg radiographRadiation
A flat-panel digital radiography(DR) equipment (Siemens DR AXIOM Aristos AX/VX) was used to capture full-length bipedal lower extremities in a standing position. The technician moved the detector from top to bottom, capturing four parts: the bilateral hip joints, femur, tibia and fibula and ankle joint. The exposure parameters for each part were as follows: 1st exposure - 85kV, 75mAs; 2nd exposure - 80kV, 50mAs; 3rd exposure - 75kV, 40mAs; 4th exposure - 68kV, 20mAs. The distance from the source (kv-kg) was 300cm, and the field of view was 43.18cm x 43.18cm. All 4 X-rays were stitched using the Siemens DR Station.
| Study group | Role | What they receive |
|---|---|---|
| OA group | Data for consecutive OA patients with knee pain who underwent primary TKA by one senior surgeon between August 2021 and July 2023 at a single institution were analyzed retrospectively. A total of 273 patients underwent long-leg radiographs. The following 27 patients were excluded from this study: prior total hip arthroplasty, 2; obvious bony deficiency of the femur or tibia, 10; simultaneous flexion of the knee and rotation of the leg on radiographs, 15. CPAK distribution of the remaining 246 cases(unilateral, 15; bilateral, 231; totally 477 knees) was examined. Receives: Radiation: long-leg radiograph | |
| healthy group | Data for consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity between January 2023 and July 2023 at the same institution were analyzed retrospectively. A total of 136 visitors were recruited. The following 18 visitors were excluded from this study: extra-articular deformity of the femur or tibia, 15; simultaneous flexion of the knee and rotation of the leg on radiographs, 13; poor quality image, 1. CPAK distribution of the remaining 107 cases(214 knees) was examined. Receives: Radiation: long-leg radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAK distribution
distribution of coronal plane alignment of the knee classification
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start22 Nov 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 353 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Liu, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158425
- Sponsor's protocol ID
- FirstJilinUQX
- Status last verified
- Nov 2023
- First submitted
- 26 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao YH, Qi YM, Huang PH, Zhao XY, Qi X. Joint line convergence angle should be considered when constitutional alignment is predicted based on arithmetic hip-knee-ankle angle: a retrospective cross-sectional observational study. Int J Surg. 2025 Jan 1;111(1):1624-1628. doi: 10.1097/JS9.0000000000002097.
PubMed 39361874Gao YH, Qi YM, Huang PH, Zhao XY, Qi X. Distribution of coronal plane alignment of the knee classification in Chinese osteoarthritic and healthy population: a retrospective cross-sectional observational study. Int J Surg. 2024 May 1;110(5):2583-2592. doi: 10.1097/JS9.0000000000001178.
PubMed 38349219
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Coronal Plane Alignment of the Knee Classification in Chinese Osteoarthritic as Well as Healthy Population
- ClinicalTrials.gov ID
- NCT06158425
- Acronym / sponsor ID
- FirstJilinUQX
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 353 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 6 Dec 2023 (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.
coronal plane alignment of the knee(CPAK) distribution of 246 cases(477 knees) of OA patients and 107 cases(214 knees) of healthy people were examined on long-leg radiographs retrospectively. Radiological measurements and CPAK classification on different Kellgren- Lawrence(K-L) Grade in patients with unilateral total knee arthroplasty(TKA) were compared. Clinical outcomes of CPAK type I patients performed by mechanical alignment(MA) and restricted kinematic alignment(rKA) during TKA were examined. ML algorithm including K nearest neighbors (KNN), random forest(RF), artificial neural networks (ANN), logistic regression(LR) and gradient boosting (GBDT) were established, the dependent variable was set as whether the constitutional phenotype of an arthritic knee classified as type I was type I.
Detailed description
Study groups and design OA group Data for consecutive OA patients with knee pain who underwent primary TKA by one senior surgeon between August 2021 and July 2023 at a single institution were analyzed retrospectively. A total of 273 patients underwent long-leg radiographs. The following 27 patients were excluded from this study: prior total hip arthroplasty, 2; obvious bony deficiency of the femur or tibia, 10; simultaneous flexion of the knee and rotation of the leg on radiographs, 15. CPAK distribution of the remaining 246 cases(unilateral, 15; bilateral, 231; totally 477 knees) was examined.
healthy group Data for consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity between January 2023 and July 2023 at the same institution were analyzed retrospectively. A total of 136 visitors were recruited. The following 18 visitors were excluded from this study: extra-articular deformity of the femur or tibia, 15; simultaneous flexion of the knee and rotation of the leg on radiographs, 13; poor quality image, 1. CPAK distribution of the remaining 107 cases(214 knees) was examined.
Radiological measurements All participants underwent standard digital long leg radiographs. The mechanical axis of the femur was marked from the centre of the femoral head to the centre of the knee. The centre of the head was marked using the concentric-circle method to identify the centre. The centre of the ankle was marked as the point on the talar dome at mid-width. The mHKA angle was the angle subtended by the mechanical axes of the femur and tibia. The LDFA was defined as the lateral angle formed between the femoral mechanical axis and the joint line of the distal femur. The MPTA was defined as the medical angle formed between the tibial mechanical axis and the joint line of the proximal tibia. Joint line convergence angle(JLCA) was the angle formed between joint orientation lines on opposite sides of the same joint[17]. All measurements were carried out by an orthopaedic fellow. A senior author undertook a subgroup analysis of 60 knees in OA group and repeated at one- week intervals to assess for inter- and intra- observer agreement.
CPAK classification of OA and healthy group aHKA was calculated based on the following formula: aHKA=MPTA-LDFA. JLO was calculated by the formula: JLO=MPTA+LDFA. With aHKA and JLO measured, patients can be matched to 9 possible CPAK alignment groups. The mean aHKA and JLO of the two groups were rounded to the nearest whole number for final allocation to a CPAK Class. CPAK limits for the definition of neutral knees was an aHKA of 0 ± 2 degrees. CPAK boundaries for a neutral JLO were defined as 180 ± 3 degrees, varus aHKA less than-2 degrees and a valgus aHKA more than+2 degrees. An apex distal JLO was less than 177°, while an apex proximal JLO was greater than 183°[9]. The OA and healthy group were categorized according to the CPAK classification, and their distribution were investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA group | – | Radiation: long-leg radiographData for consecutive OA patients with knee pain who underwent primary TKA by one senior surgeon between August 2021 and July 2023 at a single institution were analyzed retrospectively. A total of 273 patients underwent long-leg radiographs. The following 27 patients were excluded from this study: prior total hip arthroplasty, 2; obvious bony deficiency of the femur or tibia, 10; simultaneous flexion of the knee and rotation of the leg on radiographs, 15. CPAK distribution of the remaining 246 cases(unilateral, 15; bilateral, 231; totally 477 knees) was examined. |
| healthy group | – | Radiation: long-leg radiographData for consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity between January 2023 and July 2023 at the same institution were analyzed retrospectively. A total of 136 visitors were recruited. The following 18 visitors were excluded from this study: extra-articular deformity of the femur or tibia, 15; simultaneous flexion of the knee and rotation of the leg on radiographs, 13; poor quality image, 1. CPAK distribution of the remaining 107 cases(214 knees) was examined. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OA group: consecutive OA patients with knee pain who underwent primary TKA Healthy group: consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity
Key inclusion criteria (2 listed)
- OA group: Data for consecutive OA patients with knee pain who underwent primary TKA by one senior surgeon between August 2021 and July 2023 at a single institution were analyzed retrospectively.
- Healthy group: Data for consecutive visitors at outpatient clinic who underwent long-leg radiographs but without any sign of cartilage degeneration or medical history of low extremity between January 2023 and July 2023 at the same institution were analyzed retrospectively.
Key exclusion criteria (1 listed)
- OA group: prior total hip arthroplasty; obvious bony deficiency of the femur or tibia, simultaneous flexion of the knee and rotation of the leg on radiographs Healthy group: extra-articular deformity of the femur or tibia; simultaneous flexion of the knee and rotation of the leg on radiographs; poor quality image
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 |
|---|---|---|
| long-leg radiographA flat-panel digital radiography(DR) equipment (Siemens DR AXIOM Aristos AX/VX) was used to capture full-length bipedal lower extremities in a standing position. The technician moved the detector from top to bottom, capturing four parts: the bilateral hip joints, femur, tibia and fibula and ankle joint. The exposure parameters for each part were as follows: 1st exposure - 85kV, 75mAs; 2nd exposure - 80kV, 50mAs; 3rd exposure - 75kV, 40mAs; 4th exposure - 68kV, 20mAs. The distance from the source (kv-kg) was 300cm, and the field of view was 43.18cm x 43.18cm. All 4 X-rays were stitched using the Siemens DR Station. | Radiation | OA group, healthy group |
Primary outcome
CPAK distribution
Time frame: before surgery
distribution of coronal plane alignment of the knee classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 39361874Gao YH, Qi YM, Huang PH, Zhao XY, Qi X. Joint line convergence angle should be considered when constitutional alignment is predicted based on arithmetic hip-knee-ankle angle: a retrospective cross-sectional observational study. Int J Surg. 2025 Jan 1;111(1):1624-1628. doi: 10.1097/JS9.0000000000002097.
- Derived from this study: PubMed 38349219Gao YH, Qi YM, Huang PH, Zhao XY, Qi X. Distribution of coronal plane alignment of the knee classification in Chinese osteoarthritic and healthy population: a retrospective cross-sectional observational study. Int J Surg. 2024 May 1;110(5):2583-2592. doi: 10.1097/JS9.0000000000001178.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Bin Liu study chair
The First Hospital of Jilin 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 The First Hospital of Jilin University 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Qi, Dr. (+8615843073202, dr.qixin@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAK distribution (time frame: before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158425, which also lists 2 linked publications.
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 6 Dec 2023.