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A Randomized Study on Sagittal Angle Differences in Lower Limbs Between Normal Individuals and Osteoarthritis Patients

StatusUnknown
PhaseNot specified
Started2024-09-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 6, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Not Yet Recruiting → Unknown
2024-08-04
minor
Study Status, Outcome Measures v1
Trial statusNot Yet Recruiting→Unknown
Primary endpoints4 to 7 entries
Coronal Hip-Knee-Ankle Angle (HKA), Lateral Distal Femoral Angle (LDFA), Medial Proximal Tibial Angle (MPTA). Sagittal plane femur lateral, tibia lateral modified mechanical axis angle; angle formed by the line connecting the center of the femoral hea [...] r of the ankle joint, and the hinge point of the knee joint. Coronal Hip-Knee-Ankle Angle (HKA) Lateral Distal Femoral Angle (LDFA) Medial Proximal Tibial Angle (MPTA) Sagittal plane femur lateral, tibia lateral modified mechanical axis angle.
2024-07-25
minor
Original filing
With China gradually entering an aging society, the proportion of the elderly population is gradually increasing, and the number of patients with knee disease is also increasing year by year. Total knee arthroplasty is one of the effective methods for the treatment of joint disease, which can effectively relieve knee pain, restore function and improve the quality of life. The goal of total knee arthroplasty is to relieve pain, restore function and obtain a long service life. Whether total knee arthroplasty can obtain good alignment is very important for the postoperative recovery of patients. The alignment of lower limb sagittal position is of great significance for evaluating whether the crowd is straightened or not, and can also evaluate and guide the TKA in sagittal position. At present, there are few studies on the sagittal position of the lower limb, and there is no clear definition of whether the lower limb is extended in the sagittal position. At the same time, there is no clear method to evaluate whether the lower limb is extended in the sagittal position in normal people and patients with OA. Therefore, it is urgent to develop a classification standard for the sagittal extension of the lower limb, which can be used in clinical evaluation and TKA operation evaluation. This study will be carried out in the first medical center of the Chinese PLA General Hospital, and a total of about 400 people are expected to be enrolled.
Trial Details
NCT Number NCT06527924
Lead Sponsor Chinese PLA General Hospital
Conditions OA, TKA, EOS
Enrollment 400 participants
Start Date 2024-09-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-06