Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158425
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-26
Brief Title:
Constitutional Alignment in Osteoarthritic and Healthy Chinese
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Distribution of Coronal Plane Alignment of the Knee Classification in Chinese Osteoarthritic as Well as Healthy Population
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
coronal plane alignment of the kneeCPAK distribution of 246 cases477 knees of OA patients and 107 cases214 knees of healthy people were examined on long-leg radiographs retrospectively Radiological measurements and CPAK classification on different Kellgren- LawrenceK-L Grade in patients with unilateral total knee arthroplastyTKA were compared Clinical outcomes of CPAK type I patients performed by mechanical alignmentMA and restricted kinematic alignmentrKA during TKA were examined ML algorithm including K nearest neighbors KNN random forestRF artificial neural networks ANN logistic regressionLR 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 casesunilateral 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 cases214 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 angleJLCA was the angle formed between joint orientation lines on opposite sides of the same joint17 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 aHKAMPTA-LDFA JLO was calculated by the formula JLOMPTALDFA 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 than2 degrees An apex distal JLO was less than 177 while an apex proximal JLO was greater than 1839 The OA and healthy group were categorized according to the CPAK classification and their distribution were investigated
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 cases214 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 angleJLCA was the angle formed between joint orientation lines on opposite sides of the same joint17 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 aHKAMPTA-LDFA JLO was calculated by the formula JLOMPTALDFA 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 than2 degrees An apex distal JLO was less than 177 while an apex proximal JLO was greater than 1839 The OA and healthy group were categorized according to the CPAK classification and their distribution were investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None