Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03563131
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2018-06-08
Brief Title:
Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona TKA
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona Total Knee Arthroplasty A RCT Using RSA and DEXA Analysis for Evaluation of Uncemented With Trabecular Metal Surface vs Cemented Fixation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study
In a prospective randomized study with 2 years of follow-up we want to compare the migration of the uncemented trabecular metal TM versus the cemented tibial and femoral components of the new Persona total knee arthroplasty TKA assessed by model based radiostereometric analysis MB-RSA Also we want to compare the adaptive bone remodeling induced by the uncemented TM versus the cemented tibial and femoral components of the new Persona TKA assessed by dual energy-X-ray DEXA Data generated for both above mentioned will be also compared with historical RSA and DEXA data for the NexGen TKA using TM tibia modular and monoblock
In a prospective randomized study with 2 years of follow-up we want to compare the migration of the uncemented trabecular metal TM versus the cemented tibial and femoral components of the new Persona total knee arthroplasty TKA assessed by model based radiostereometric analysis MB-RSA Also we want to compare the adaptive bone remodeling induced by the uncemented TM versus the cemented tibial and femoral components of the new Persona TKA assessed by dual energy-X-ray DEXA Data generated for both above mentioned will be also compared with historical RSA and DEXA data for the NexGen TKA using TM tibia modular and monoblock
Detailed Description:
Detailed Description Main Hypothesis
1 The uncemented TM Zimmer Persona TKA will have migration on the same level as the cemented Zimmer Persona TKA
2 The uncemented TM Zimmer Persona TKA will have less loss of BMD compared to the cemented version of the implant
Material and Methods
A prospective randomized study where the patients scheduled for TKA are randomized to receive tibial and femoral components with two different fixation modes
Group A an uncemented TM Zimmer Persona TKA uncemented tibia and femur components
Group B a cemented Zimmer Persona TKA cemented tibia and femur components Operation Operation Planning of the operations are performed based upon standing knee X-rays not involving the ankle and hip joint and no preoperative templating is performed The operations are performed at the Department of Orthopedic Surgery Gentofte Hospital by three experienced TKA surgeons that will be included in the research group All patellas will be resurfaced with a cemented all polyethylene patella component During surgery the patients participating in the study will be prepared for MB-RSA by insertion of a minimum of 6 Tantalum markers 08 mm in the bone of the proximal tibia and 6 markers in the distal femur
Intravenous antibiotics 15g Cefuroxim are administered three times during the first day and night of surgery and low molecular weight heparin is administered for prevention of deep venous thrombosis and pulmonary embolism Local analgesics Naropin Toradol are injected in the knee joint and in the soft tissue around the knee during surgery Physiotherapy begins on the day of surgery and the patients will be mobilized with full weight-bearing using crutches
Research plan
1 Clinical examination n60 preoperatively and with follow-up after 1 and 2 years with evaluation of the knee function using the Knee Societys Knee Scoring System
2 Patient-reported outcome measurements n60 Obtained preoperatively and after 1 and 2 years using the Oxford knee score
3 Conventional X-rays n60 are obtained preoperatively standing knee X-rays not involving the ankle and hip joint with classification of the degree of arthrosis estimating the Ahlbäck score X-rays are also obtained postoperatively before the patients are discharged and after 1 year and 2 years with the aim of evaluating knee alignment and development of osteolytic lesions
4 CT-scans n60 3 months postoperatively for measurements of hip-knee-ankle HKA angle and component slope rotation and size matching
5 Special X-rays suitable for MB-RSA measurements n60 of migration of the tibial and femoral components is performed within the first week after the operation and after 3 6 12 and 24 months The precision of the RSA measurements is estimated from double examinations in 12 patients of the study RSA X-rays will be performed using a biplane RSA arrangement with a 90 angle between the two X-ray tubes Calibration cage 21 Tilly Medical Products AB Lund Sweden and analysis of X-rays will be performed by the MB-RSA commercial software RSAcore Department of Orthopedics Leiden University Medical Center Leiden The Netherlands available at the Skaane University Hospital Lund Sweden The manufacturer Zimmer Biomet will provide the CAD models
6 DEXA analysis of the adaptive changes in BMD of the periprosthetic bone of the distal femur and proximal tibia DEXA analysis will be performed preoperatively of the distal femur lateral projection and proximal tibia coronal projection as baseline then again within the first postoperative week and subsequently at 3 months 6 months 1 year and 2 years The precision of the BMD measurements of the proximal tibia and distal femur will be estimated from double measurements of patients n12 included in the study
Calculation of sample size MB-RSA There exist only three previously published studies measuring femoral component migration In all studies the marker-based RSA technique was used and none of them presented results with mean and standard deviation SD However one study gave the results as mean MTPM and we chose the mean MTPM after 2 years of follow-up 088 mm for cemented components as our primary effect parameter used in the sample size calculation The rationale for using MTPM two years postoperatively is because it has been shown to be the best predictor for later aseptic loosening of the tibial component after primary TKA SD was estimated from the most recently published study using MB-RSA for evaluation of cemented tibial component migration In that study the mean - SD MTPM after 2 years of follow-up was 047 - 016 and 045 -021 in the two study groups Since the level of MTPM of the tibial components was substantially lower than seen for the above mentioned femoral components We adjusted the SD in the sample size calculation to constitute the same percentages of the mean values as in the tibial component MB-RSA study by Ejaz et al 2015 Since the previously published studies measuring femoral component migration did not find any statistically significant difference between cemented and uncemneted fixation we selected a relatively low minimum relevant difference MIREDIF
Using
Type I error 5 Statistical power 85 MIREDIF 03 mm SD 035 mm Sample size calculation resulted in a sample size of n 24 in each group In the study we have planned to include and randomize block-randomization with 10 in each block a total of 60 patients This will secure a high statistical power even if some of the participants should drop out during the study
DEXA
The data for the sample size calculations were obtained from new DEXA data for our own research group data from a study evaluating the adaptive bone remodeling around the Vanguard uncemented porous-coated femoral component with one year of follow-up Using one-year follow-up data could be justified because the decrease in BMD seen beyond the first postoperative year is very limited in most studies We considered a difference of 8 between groups to be a clinically relevant difference that we wanted to be able to detect with a high statistical power
Using
Type I error 5 Statistical power 90 MIREDIF 8 SD 84 Sample size calculation resulted in a sample size of n 25 in each group
In the study we have planned to include and randomize block-randomization with 10 in each block a total of 60 patients This will secure a high statistical power even if some of the participants should drop out during the study
Ethical considerations We do not expect that the patients participating in the study will experience any special side effects or complications related to the use of the two TKAs
There has not been performed any fundamental changes in implant design compared to other types of standard TKAs and the implant fixation modes cemented or uncemented with a TM ingrowth surface are well known and in wide spread use
Radiation dose to the patients from MB-RSA X-rays and DEXA is relatively low compared with many conventional X-ray examinationsThe total accumulated radiation dose to a patient participating in all examinations during the study is estimated to be approximately 2 mSv
Tantalum has been used for more than 50 years and is a very biocompatible material without any tendency to corrosionTantalum beads for RSA have been used in several clinical studies for more than 20 years More than 20000 beads have been implanted in more than 2000 patients and no side effects from Tantalum beads have been observed
This investigation will be performed in accordance with the principles of the Helsinki Declaration and all patients will receive both oral and written information before informed consent to participate is obtained At any time being the patient will be able to cancel participation also without any explanation in this investigation The patient will receive the best possible treatment in any circumstances The study will not be started until approval from the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency has been obtained and it will be registered at clinicaltrialsgov
Risks and inconveniencesThis investigation will not add to the general risks of getting TKA Patients participating must accept some inconvenience in terms of additional examinations and hence transportation to and from the hospitals
Adverse events All adverse events will be recorded in the CRF and will include details concerning the nature onset duration severity relationship to the device and relationship to the operative procedure and outcome The affected patients will be questioned about any adverse events at each subsequent follow-up visit
Patients experiencing adverse events will be relevantly monitored by clinical assessment and lab examinations decided by the treating physician All adverse events will be monitored until recovery or stabilization
Information and consent Patients who are planned to receive a TKA and fits within the inclusion and exclusion criteria of the study at Gentofte Hospital will be informed about the trial in the preoperative interview In addition to the oral information provided the patients will be given written information This conversation will take place in an enclosed space without distractions or interruptions The patient will receive adequate verbal and written information about the purposes processes potential benefits and risks including possible side effects Investigator will ensure all patients have read and understood the information and consent form Patients will be informed that they are entitled to consideration before consent is given The subjects will also be informed that it is voluntary and that they at any time may withdraw from the trial It is the investigators responsibility to ensure the above
There will be obtained written informed consent from all subjects before enrollment and a copy of the information and consent form will be given to the subjectsExisting legislations made by the Scientific Ethical Committee regarding informed consent will be followed
Data protection All information will be kept confidential and all data handled according the guidelines of the Danish Data Protection agency The persons involved in this trial are obliged to professional secrecy The investigator will maintain a list of identification of all enrolled patients This list will contain the patients full names and dates of birth including social security numbers CPR-numbers
Collected data will be recorded in a case report form CRF CRFs and the medical records will be made available to third parties according to Danish law Patients will be informed in writing that the results will be stored and analyzed in a computer which preserve patients anonymity and that the local laws regarding personal data will be complied
Patients will also receive written information concerning the possibility of audit from the public authorities and patients will be informed that the GCP unit of Copenhagen University Hospital likewise is granted access
Investigator ensures that the project will follow the rules of Good Clinical Practice
1 The uncemented TM Zimmer Persona TKA will have migration on the same level as the cemented Zimmer Persona TKA
2 The uncemented TM Zimmer Persona TKA will have less loss of BMD compared to the cemented version of the implant
Material and Methods
A prospective randomized study where the patients scheduled for TKA are randomized to receive tibial and femoral components with two different fixation modes
Group A an uncemented TM Zimmer Persona TKA uncemented tibia and femur components
Group B a cemented Zimmer Persona TKA cemented tibia and femur components Operation Operation Planning of the operations are performed based upon standing knee X-rays not involving the ankle and hip joint and no preoperative templating is performed The operations are performed at the Department of Orthopedic Surgery Gentofte Hospital by three experienced TKA surgeons that will be included in the research group All patellas will be resurfaced with a cemented all polyethylene patella component During surgery the patients participating in the study will be prepared for MB-RSA by insertion of a minimum of 6 Tantalum markers 08 mm in the bone of the proximal tibia and 6 markers in the distal femur
Intravenous antibiotics 15g Cefuroxim are administered three times during the first day and night of surgery and low molecular weight heparin is administered for prevention of deep venous thrombosis and pulmonary embolism Local analgesics Naropin Toradol are injected in the knee joint and in the soft tissue around the knee during surgery Physiotherapy begins on the day of surgery and the patients will be mobilized with full weight-bearing using crutches
Research plan
1 Clinical examination n60 preoperatively and with follow-up after 1 and 2 years with evaluation of the knee function using the Knee Societys Knee Scoring System
2 Patient-reported outcome measurements n60 Obtained preoperatively and after 1 and 2 years using the Oxford knee score
3 Conventional X-rays n60 are obtained preoperatively standing knee X-rays not involving the ankle and hip joint with classification of the degree of arthrosis estimating the Ahlbäck score X-rays are also obtained postoperatively before the patients are discharged and after 1 year and 2 years with the aim of evaluating knee alignment and development of osteolytic lesions
4 CT-scans n60 3 months postoperatively for measurements of hip-knee-ankle HKA angle and component slope rotation and size matching
5 Special X-rays suitable for MB-RSA measurements n60 of migration of the tibial and femoral components is performed within the first week after the operation and after 3 6 12 and 24 months The precision of the RSA measurements is estimated from double examinations in 12 patients of the study RSA X-rays will be performed using a biplane RSA arrangement with a 90 angle between the two X-ray tubes Calibration cage 21 Tilly Medical Products AB Lund Sweden and analysis of X-rays will be performed by the MB-RSA commercial software RSAcore Department of Orthopedics Leiden University Medical Center Leiden The Netherlands available at the Skaane University Hospital Lund Sweden The manufacturer Zimmer Biomet will provide the CAD models
6 DEXA analysis of the adaptive changes in BMD of the periprosthetic bone of the distal femur and proximal tibia DEXA analysis will be performed preoperatively of the distal femur lateral projection and proximal tibia coronal projection as baseline then again within the first postoperative week and subsequently at 3 months 6 months 1 year and 2 years The precision of the BMD measurements of the proximal tibia and distal femur will be estimated from double measurements of patients n12 included in the study
Calculation of sample size MB-RSA There exist only three previously published studies measuring femoral component migration In all studies the marker-based RSA technique was used and none of them presented results with mean and standard deviation SD However one study gave the results as mean MTPM and we chose the mean MTPM after 2 years of follow-up 088 mm for cemented components as our primary effect parameter used in the sample size calculation The rationale for using MTPM two years postoperatively is because it has been shown to be the best predictor for later aseptic loosening of the tibial component after primary TKA SD was estimated from the most recently published study using MB-RSA for evaluation of cemented tibial component migration In that study the mean - SD MTPM after 2 years of follow-up was 047 - 016 and 045 -021 in the two study groups Since the level of MTPM of the tibial components was substantially lower than seen for the above mentioned femoral components We adjusted the SD in the sample size calculation to constitute the same percentages of the mean values as in the tibial component MB-RSA study by Ejaz et al 2015 Since the previously published studies measuring femoral component migration did not find any statistically significant difference between cemented and uncemneted fixation we selected a relatively low minimum relevant difference MIREDIF
Using
Type I error 5 Statistical power 85 MIREDIF 03 mm SD 035 mm Sample size calculation resulted in a sample size of n 24 in each group In the study we have planned to include and randomize block-randomization with 10 in each block a total of 60 patients This will secure a high statistical power even if some of the participants should drop out during the study
DEXA
The data for the sample size calculations were obtained from new DEXA data for our own research group data from a study evaluating the adaptive bone remodeling around the Vanguard uncemented porous-coated femoral component with one year of follow-up Using one-year follow-up data could be justified because the decrease in BMD seen beyond the first postoperative year is very limited in most studies We considered a difference of 8 between groups to be a clinically relevant difference that we wanted to be able to detect with a high statistical power
Using
Type I error 5 Statistical power 90 MIREDIF 8 SD 84 Sample size calculation resulted in a sample size of n 25 in each group
In the study we have planned to include and randomize block-randomization with 10 in each block a total of 60 patients This will secure a high statistical power even if some of the participants should drop out during the study
Ethical considerations We do not expect that the patients participating in the study will experience any special side effects or complications related to the use of the two TKAs
There has not been performed any fundamental changes in implant design compared to other types of standard TKAs and the implant fixation modes cemented or uncemented with a TM ingrowth surface are well known and in wide spread use
Radiation dose to the patients from MB-RSA X-rays and DEXA is relatively low compared with many conventional X-ray examinationsThe total accumulated radiation dose to a patient participating in all examinations during the study is estimated to be approximately 2 mSv
Tantalum has been used for more than 50 years and is a very biocompatible material without any tendency to corrosionTantalum beads for RSA have been used in several clinical studies for more than 20 years More than 20000 beads have been implanted in more than 2000 patients and no side effects from Tantalum beads have been observed
This investigation will be performed in accordance with the principles of the Helsinki Declaration and all patients will receive both oral and written information before informed consent to participate is obtained At any time being the patient will be able to cancel participation also without any explanation in this investigation The patient will receive the best possible treatment in any circumstances The study will not be started until approval from the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency has been obtained and it will be registered at clinicaltrialsgov
Risks and inconveniencesThis investigation will not add to the general risks of getting TKA Patients participating must accept some inconvenience in terms of additional examinations and hence transportation to and from the hospitals
Adverse events All adverse events will be recorded in the CRF and will include details concerning the nature onset duration severity relationship to the device and relationship to the operative procedure and outcome The affected patients will be questioned about any adverse events at each subsequent follow-up visit
Patients experiencing adverse events will be relevantly monitored by clinical assessment and lab examinations decided by the treating physician All adverse events will be monitored until recovery or stabilization
Information and consent Patients who are planned to receive a TKA and fits within the inclusion and exclusion criteria of the study at Gentofte Hospital will be informed about the trial in the preoperative interview In addition to the oral information provided the patients will be given written information This conversation will take place in an enclosed space without distractions or interruptions The patient will receive adequate verbal and written information about the purposes processes potential benefits and risks including possible side effects Investigator will ensure all patients have read and understood the information and consent form Patients will be informed that they are entitled to consideration before consent is given The subjects will also be informed that it is voluntary and that they at any time may withdraw from the trial It is the investigators responsibility to ensure the above
There will be obtained written informed consent from all subjects before enrollment and a copy of the information and consent form will be given to the subjectsExisting legislations made by the Scientific Ethical Committee regarding informed consent will be followed
Data protection All information will be kept confidential and all data handled according the guidelines of the Danish Data Protection agency The persons involved in this trial are obliged to professional secrecy The investigator will maintain a list of identification of all enrolled patients This list will contain the patients full names and dates of birth including social security numbers CPR-numbers
Collected data will be recorded in a case report form CRF CRFs and the medical records will be made available to third parties according to Danish law Patients will be informed in writing that the results will be stored and analyzed in a computer which preserve patients anonymity and that the local laws regarding personal data will be complied
Patients will also receive written information concerning the possibility of audit from the public authorities and patients will be informed that the GCP unit of Copenhagen University Hospital likewise is granted access
Investigator ensures that the project will follow the rules of Good Clinical Practice
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