Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527911
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic TKA and Manual TKA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic Total Knee Arthroplasty and Manual Total Knee Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
As China transitions into an aging society the proportion of the elderly population is escalating with a corresponding rise in the number of patients with knee joint diseases Total knee arthroplasty stands as an effective treatment for joint disorders effectively reducing knee pain restoring functionality and enhancing quality of life The objectives of total knee arthroplasty are to relieve pain restore function and ensure a long-lasting implant In recent years technological advancements have integrated robotic assistance into total knee arthroplasty TKA aiding surgeons in planning and executing more accurate surgical plans significantly enhancing precision and post-operative outcomes However the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures necessitating adjustments by surgeons based on their experience Consequently there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment Additionally the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA necessitating further comparative analysis to draw definitive conclusions This study will be carried out at the Peoples Liberation Army General Hospital with an anticipated enrollment of approximately 100 participants
Detailed Description:
I Clinical Research Background As China transitions into an aging society the proportion of the elderly population is escalating with a corresponding rise in the number of patients with knee joint diseases Total knee arthroplasty stands as an effective treatment for joint disorders effectively reducing knee pain restoring functionality and enhancing quality of life The objectives of total knee arthroplasty are to relieve pain restore function and ensure a long-lasting implant In recent years technological advancements have integrated robotic assistance into total knee arthroplasty TKA aiding surgeons in planning and executing more accurate surgical plans significantly enhancing precision and post-operative outcomes However the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures necessitating adjustments by surgeons based on their experience Consequently there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment Additionally the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA necessitating further comparative analysis to draw definitive conclusions
II Content of Clinical Trials I Overall Design and Sample Size This study is a prospective clinical investigation encompassing two groups ① the Mako robot-assisted TKA group patients with osteoarthritis OA who underwent Mako robot-assisted TKA at the Chinese PLA General Hospital between September 2024 and September 2026 and ② the manual TKA group patients with OA who underwent manual TKA at the same hospital between September 2024 and September 2026
II Randomization and Control in the Trial Randomized Controlled Trial III Content This clinical study aims to compare the differences between the extension demonstrated during Mako robot-assisted TKA surgery and the actual postoperative extension proposing a mathematical formula to reflect these discrepancies Through the validation of intraoperative and postoperative data the study aims to guide the extension during Mako-assisted TKA Additionally In Mako-assisted TKA there is a femoral prosthesis bowing down issue and the posterior inclination angle of the tibial plateau differs from that of manual TKA Consequently the sagittal femoral bowing down angle and posterior inclination angle of the tibial plateau were compared between robot-assisted TKA and manual TKA to verify the differences between the groupsThis study was conducted at the Joint Surgery Department of the Chinese PLA General Hospital with participants meeting inclusion criteria and not violating exclusion criteria and having signed informed consent forms approved by the ethics committee
III Trial Procedure I Participant Enrollment Physicians selected osteoarthritis OA patients who underwent total knee arthroplasty TKA 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 A clinical study was conducted at the Joint Surgery Department of the Chinese PLA General Hospital from September 2024 to September 2026 involving 50 patients each undergoing Mako robot-assisted TKA and manual TKA Stryker Triathlon prosthesis Basic patient information including ID number name gender age height and weight was recorded Preoperative and postoperative full-length lateral radiographs of the lower limbs bilateral knee joint lateral radiographs and sagittal EOS of the lower limbs were taken for all patients An experienced researcher measured the posterior slope angle of the tibial plateau preoperatively and postoperatively using the Mako robot-assisted TKA as well as the extension angle displayed by the Mako at the end of the TKA procedure Based on the differences preoperatively and postoperatively in the 50 cases of Mako robot-assisted TKA a mathematical formula reflecting extension was proposed and validated Preoperative and postoperative coronal HKA LDFA and MPTA measurements were taken for both Mako robot-assisted TKA and manual TKA preoperative and postoperative sagittal measurements of the posterior slope angle of the tibial plateau and postoperative femoral prosthesis head tilt angle were recorded and statistical analysis was conducted to compare the sagittal angle differences between Mako robot-assisted and manual TKA
III Clinical Evaluation Indices 1 Primary Outcome Measures
1 The extension angle displayed by the Mako robot at the conclusion of the Mako-assisted Total Knee Arthroplasty TKA procedure
2 Sagittal plane femoral anterior arch angle
3 Preoperative and postoperative coronal hip-knee-ankle HKA angles lateral distal femoral angle LDFA and medial proximal tibial angle MPTA in Mako robot-assisted TKA and manual TKA
4 Preoperative and postoperative sagittal measurement of the tibial plateau posterior slope angle postoperative femoral prosthesis head-down angle
2 Secondary Observational Indicators
1 Basic demographic data of the patients
Statistical Analysis Methods All results were computed using SPSS 260 A comprehensive enumeration of the 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 at each evaluation time point mean values mean differences relative to baseline values where appropriate medians standard deviations 95 confidence intervals minimum values and maximum values
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 the Mako robot-assisted TKA group patients with osteoarthritis OA who underwent Mako robot-assisted TKA at the Chinese PLA General Hospital between September 2024 and September 2026 and ② the manual TKA group patients with OA who underwent manual TKA at the same hospital between September 2024 and September 2026
II Randomization and Control in the Trial Randomized Controlled Trial III Content This clinical study aims to compare the differences between the extension demonstrated during Mako robot-assisted TKA surgery and the actual postoperative extension proposing a mathematical formula to reflect these discrepancies Through the validation of intraoperative and postoperative data the study aims to guide the extension during Mako-assisted TKA Additionally In Mako-assisted TKA there is a femoral prosthesis bowing down issue and the posterior inclination angle of the tibial plateau differs from that of manual TKA Consequently the sagittal femoral bowing down angle and posterior inclination angle of the tibial plateau were compared between robot-assisted TKA and manual TKA to verify the differences between the groupsThis study was conducted at the Joint Surgery Department of the Chinese PLA General Hospital with participants meeting inclusion criteria and not violating exclusion criteria and having signed informed consent forms approved by the ethics committee
III Trial Procedure I Participant Enrollment Physicians selected osteoarthritis OA patients who underwent total knee arthroplasty TKA 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 A clinical study was conducted at the Joint Surgery Department of the Chinese PLA General Hospital from September 2024 to September 2026 involving 50 patients each undergoing Mako robot-assisted TKA and manual TKA Stryker Triathlon prosthesis Basic patient information including ID number name gender age height and weight was recorded Preoperative and postoperative full-length lateral radiographs of the lower limbs bilateral knee joint lateral radiographs and sagittal EOS of the lower limbs were taken for all patients An experienced researcher measured the posterior slope angle of the tibial plateau preoperatively and postoperatively using the Mako robot-assisted TKA as well as the extension angle displayed by the Mako at the end of the TKA procedure Based on the differences preoperatively and postoperatively in the 50 cases of Mako robot-assisted TKA a mathematical formula reflecting extension was proposed and validated Preoperative and postoperative coronal HKA LDFA and MPTA measurements were taken for both Mako robot-assisted TKA and manual TKA preoperative and postoperative sagittal measurements of the posterior slope angle of the tibial plateau and postoperative femoral prosthesis head tilt angle were recorded and statistical analysis was conducted to compare the sagittal angle differences between Mako robot-assisted and manual TKA
III Clinical Evaluation Indices 1 Primary Outcome Measures
1 The extension angle displayed by the Mako robot at the conclusion of the Mako-assisted Total Knee Arthroplasty TKA procedure
2 Sagittal plane femoral anterior arch angle
3 Preoperative and postoperative coronal hip-knee-ankle HKA angles lateral distal femoral angle LDFA and medial proximal tibial angle MPTA in Mako robot-assisted TKA and manual TKA
4 Preoperative and postoperative sagittal measurement of the tibial plateau posterior slope angle postoperative femoral prosthesis head-down angle
2 Secondary Observational Indicators
1 Basic demographic data of the patients
Statistical Analysis Methods All results were computed using SPSS 260 A comprehensive enumeration of the 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 at each evaluation time point mean values mean differences relative to baseline values where appropriate medians standard deviations 95 confidence intervals minimum values and maximum values
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