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

NCT06527924 | Not Yet Recruiting

• 1 other identifier: 2023KY024-KS001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

OA; TKA; EOS

Outcome Measures

Primary Outcomes (7)

• Sagittal plane femur lateral, tibia lateral modified mechanical axis angle.

  From admission to discharge, up to 1 week

• Angle formed by the line connecting the center of the femoral head, the center of the ankle joint, and the hinge point of the knee joint.

  From admission to discharge, up to 1 week

• Sagittal plane femoral anterior arch angle.

  From admission to discharge, up to 1 week

• Sagittal posterior slope angle of the tibial plateau.

  From admission to discharge, up to 1 week

• Coronal Hip-Knee-Ankle Angle (HKA)

  From admission to discharge, up to 1 week

• Lateral Distal Femoral Angle (LDFA)

  From admission to discharge, up to 1 week

• Medial Proximal Tibial Angle (MPTA)

  From admission to discharge, up to 1 week

Secondary Outcomes (1)

• Basic demographic profile of the patient

  From admission to discharge, up to 1 week

Study Arms (2)

Health Group

Non-osteoarthritis (OA) patients who underwent sagittal plane EOS examinations at the Chinese PLA General Hospital between September 2024 and September 2026.

OA group

OA patients who underwent sagittal plane EOS examinations at the Chinese PLA General Hospital from September 2024 to September 2026. The sagittal alignment angles on the EOS radiographs of the subjects were measured to establish a classification system for extension or non-extension.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non OA patients and OA patients undergoing EOS in our hospital from September 2024 to September 2026.

You may qualify if:

• The age ranged from 18 to 80 years old;
• Non OA examinees of lower limb sagittal EOS in the General Hospital of Chinese PLA;
• OA patients with sagittal EOS were photographed in the Department of joint surgery, General Hospital of Chinese PLA;
• Patients are willing to participate in the study and sign written informed consent.

You may not qualify if:

• People unable to conduct EOS inspection;
• Combined with knee meniscus injury, anterior cruciate ligament injury and other diseases that may affect the sagittal force line of the knee joint
• Combined with other diseases that may affect the study
• Patients refused to use their imaging data and knee score for this study

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100037, China

Location

Study Officials

• Wei Chai, doctorate

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Wei Chai, doctorate

CONTACT

13601372998; chaiwei301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)