Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527924
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Randomized Study on Sagittal Angle Differences in Lower Limbs Between Normal Individuals and Osteoarthritis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of the Difference in Sagittal Angle of the Lower Limbs Between Healthy Individuals and Patients With Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
I Clinical Research Background As China enters an aging society the elderly population is increasing leading to a rise in knee joint disease patients Total knee arthroplasty is an effective treatment for joint disorders alleviating knee pain restoring function and improving quality of lifeThe objectives of total knee arthroplasty are to relieve pain restore function and ensure a long-lasting implant Achieving good alignment is crucial for patient recovery after total knee arthroplasty The alignment of the lower limb in the sagittal plane is important for assessing whether the limb is extended or not which also guides the sagittal alignment during TKA Currently there is limited research on the sagittal alignment of the lower limb and there is no clear definition of whether the lower limb should be extended in this plane Additionally existing studies lack a clear method for assessing sagittal alignment in both normal individuals and patients with OA Consequently there is an urgent need to establish a classification standard for sagittal alignment of the lower limb applicable to clinical and TKA surgical evaluations
II Content of Clinical Trials I Overall Design and Sample Size This study is a prospective clinical investigation encompassing two groups ① Healthy Group Non-osteoarthritis OA patients who underwent sagittal plane EOS examinations at the Peoples Liberation Army General Hospital between September 2024 and September 2026 ② OA Group OA patients who underwent sagittal plane EOS examinations at the same 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
II Randomization and Control in the Study Randomized controlled trial III Content From September 2024 to September 2026 at the Chinese PLA General Hospital a cohort of 200 non-lower limb-related non-osteoarthritis OA patients who underwent sagittal plane EOS imaging was studied Basic demographic data including age weight and height were recorded An experienced researcher measured angles such as the modified mechanical axis angle femoral anterior bowing angle and tibial plateau posterior slope angle The collected data underwent statistical analysis to determine the 95 normal distribution ranges for these angles thereby establishing the sagittal plane ranges for extension overextension and extension-limited in the knee joint Additionally 200 OA patients attending the directors outpatient clinic were measured by the researcher and taken to the radiology department for sagittal plane imaging according to the established EOS requirements The same three angles were measured and recorded and the aforementioned classification was used to assess whether the OA patients were in extension or not The differences between the two groups were then compared
III Trial Procedure I Subject Enrollment Physicians selected subjects who underwent EOS imaging at our hospital from September 2024 to September 2026 and screened them based on inclusion and exclusion criteria If a patient met the inclusion criteria the details of the research project were thoroughly explained to them and they were required to sign the relevant informed consent form
II Methodology Subjects who met the inclusion criteria and underwent sagittal EOS examinations at the Radiology Department of the First Medical Center of the Chinese PLA General Hospital from September 2024 to September 2026 were included in the study Imaging data were collected under the following conditions ① the radiographer stood on one leg ② the two femoral condyles coincided on the lateral radiograph Basic demographic information including age weight and height was recorded An experienced researcher measured angles such as the modified mechanical axis angle femoral anterior bowing angle and tibial plateau posterior slope angle The obtained data were subjected to statistical analysis to determine the 95 normal distribution range values for these three angles thereby establishing the angular ranges for extension hyperextension and limited extension of the knee joint in the sagittal plane A total of 200 OA patients attending the outpatient clinic of director were measured by the researcher who then brought them to the radiology department to undergo sagittal radiography according to the established EOS imaging requirements The same three angles were measured and recorded and the aforementioned classification was used to evaluate whether the OA patients were in extension or not The differences between the two groups were compared
III Clinical Evaluation Indices
1 Primary Observational Indicators
1 Sagittal plane femur lateral tibia lateral modified mechanical axis angle 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
2 Sagittal plane femoral anterior arch angle
3 Sagittal posterior slope angle of the tibial plateau
4 Coronal Hip-Knee-Ankle Angle HKA Lateral Distal Femoral Angle LDFA Medial Proximal Tibial Angle MPTA
2 Secondary Observational Indicators
1 Basic demographic profile of the patient IV Case Report Documentation Researchers should diligently complete all research documentation including the verification of all participants capable of effectively collating diverse record-keeping materials such as case report forms and original hospital records all original signed patient informed consent forms and detailed records of all case report forms Upon the conclusion of the trial all clinical research materials shall be transferred to the Clinical Research Organizations office for safekeeping
Ⅳ Statistical Analysis Methods All results were computed using SPSS 260 A comprehensive listing of all collected data will be presented followed by a descriptive summary of the data Categorical variables will be summarized using frequencies and percentages while continuous variables will be summarized by the number of subjects mean mean difference relative to baseline if applicable median standard deviation 95 confidence intervals minimum and maximum values at each assessment time point
Prior to database lock the definitive statistical analysis plan will be established and the pertinent clinical and statistical personnel will document their decisions regarding the inclusion or exclusion of data from each subject
II Content of Clinical Trials I Overall Design and Sample Size This study is a prospective clinical investigation encompassing two groups ① Healthy Group Non-osteoarthritis OA patients who underwent sagittal plane EOS examinations at the Peoples Liberation Army General Hospital between September 2024 and September 2026 ② OA Group OA patients who underwent sagittal plane EOS examinations at the same 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
II Randomization and Control in the Study Randomized controlled trial III Content From September 2024 to September 2026 at the Chinese PLA General Hospital a cohort of 200 non-lower limb-related non-osteoarthritis OA patients who underwent sagittal plane EOS imaging was studied Basic demographic data including age weight and height were recorded An experienced researcher measured angles such as the modified mechanical axis angle femoral anterior bowing angle and tibial plateau posterior slope angle The collected data underwent statistical analysis to determine the 95 normal distribution ranges for these angles thereby establishing the sagittal plane ranges for extension overextension and extension-limited in the knee joint Additionally 200 OA patients attending the directors outpatient clinic were measured by the researcher and taken to the radiology department for sagittal plane imaging according to the established EOS requirements The same three angles were measured and recorded and the aforementioned classification was used to assess whether the OA patients were in extension or not The differences between the two groups were then compared
III Trial Procedure I Subject Enrollment Physicians selected subjects who underwent EOS imaging at our hospital from September 2024 to September 2026 and screened them based on inclusion and exclusion criteria If a patient met the inclusion criteria the details of the research project were thoroughly explained to them and they were required to sign the relevant informed consent form
II Methodology Subjects who met the inclusion criteria and underwent sagittal EOS examinations at the Radiology Department of the First Medical Center of the Chinese PLA General Hospital from September 2024 to September 2026 were included in the study Imaging data were collected under the following conditions ① the radiographer stood on one leg ② the two femoral condyles coincided on the lateral radiograph Basic demographic information including age weight and height was recorded An experienced researcher measured angles such as the modified mechanical axis angle femoral anterior bowing angle and tibial plateau posterior slope angle The obtained data were subjected to statistical analysis to determine the 95 normal distribution range values for these three angles thereby establishing the angular ranges for extension hyperextension and limited extension of the knee joint in the sagittal plane A total of 200 OA patients attending the outpatient clinic of director were measured by the researcher who then brought them to the radiology department to undergo sagittal radiography according to the established EOS imaging requirements The same three angles were measured and recorded and the aforementioned classification was used to evaluate whether the OA patients were in extension or not The differences between the two groups were compared
III Clinical Evaluation Indices
1 Primary Observational Indicators
1 Sagittal plane femur lateral tibia lateral modified mechanical axis angle 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
2 Sagittal plane femoral anterior arch angle
3 Sagittal posterior slope angle of the tibial plateau
4 Coronal Hip-Knee-Ankle Angle HKA Lateral Distal Femoral Angle LDFA Medial Proximal Tibial Angle MPTA
2 Secondary Observational Indicators
1 Basic demographic profile of the patient IV Case Report Documentation Researchers should diligently complete all research documentation including the verification of all participants capable of effectively collating diverse record-keeping materials such as case report forms and original hospital records all original signed patient informed consent forms and detailed records of all case report forms Upon the conclusion of the trial all clinical research materials shall be transferred to the Clinical Research Organizations office for safekeeping
Ⅳ Statistical Analysis Methods All results were computed using SPSS 260 A comprehensive listing of all collected data will be presented followed by a descriptive summary of the data Categorical variables will be summarized using frequencies and percentages while continuous variables will be summarized by the number of subjects mean mean difference relative to baseline if applicable median standard deviation 95 confidence intervals minimum and maximum values at each assessment time point
Prior to database lock the definitive statistical analysis plan will be established and the pertinent clinical and statistical personnel will document their decisions regarding the inclusion or exclusion of data from each subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None