Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02656771
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2016-01-13
Brief Title:
Evaluation of Stability of Two Uncemented Hip Implants Used for Total Hip Arthroplasty
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Evaluation of Uncemented Echo Bi-Metric Full Proximal Profile THA Stem Versus Uncemented Bi-Metric Porous Primary THA Stem in a Randomized Controlled Trial Using RSA and DXA
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 is to measure quantitatively the implant stability and implant related remodeling of the periprosthetic femoral bone of the new uncemented Echo Bi-Metric Full proximal Profile total hip arthroplasty THA stem and compare it to the classical uncemented Bi-Metric Porous Primary THA stem by measuring migration of the stem assessed by model-based radiosteriometric analysis MB-RSA and measuring the periprosthetic adaptive bone remodeling assessed by dual-energy x-ray absorptiometry DXA
Detailed Description:
Material and Methods Hypothesis The uncemented Echo Bi-Metric Full proximal Profile THA stem shows less migration and less bone loss of the periprosthetic bone compared to the uncemented Bi-Metric Porous Primary THA stem
Operation All operations will be performed by 4 experienced hip surgeons from the Hip unit at the Department of Orthopedic Surgery Gentofte Hospital Gentofte Denmark Each of the surgeons performs approximately 120 THA-operations a year
Surgery is performed according to a standard procedure with a postero-lateral approach and following the manufacturers recommendations During surgery a minimum of 4 Tantalum markers 08mm are inserted in the bone of the proximal femur for defining the bone segment in the RSA analysis All patients receive the same uncemented hemispheric acetabular cup Exceed with a highly cross-linked polyethylene liner No local analgesic is injected Physiotherapy begins on the day of surgery and the patients will be mobilized with full weight-bearing using crutches All patients will get oral anticoagulants according to praxis of the department Xarelto until discharge and prophylactic antibiotics Dicloxacillin 2 g preoperatively and 1g x 2 postoperatively during the first 24 hours
Research plan
1 Clinical examination performed preoperatively and with follow-up after 1 and 2 years with evaluation of the hip function using the Harris Hip Score HHS HHS is a questionnaire in which the patients reveal their level of pain function mobility and range of motion
2 Conventional X-rays To evaluate possible aseptic loosening all patients will have a standardized full pelvic antero-posterior X-ray and a lateral X-ray with fixed magnification both preoperatively postoperatively at the 2 years follow-up visit and at the 5 years follow-up visit Radiolucent lines at the bone-implant interface and evidence of osteolysis will be measured on both recordings The standard Gruen zones will be used to record radiolucency surrounding the femoral component and the acetabular zones described by DeLee and Charnley will be used to record radiolucency surrounding the acetabular component The apparent thickness of the radiolucency within these zones will be recorded Evidence of osteolysis radiolucency 2mm thickness in the periprosthetic tissue of the acetabular or femoral component will be considered a failure
3 DXA analysis of the changes in BMD of the periprosthetic Gruen zones will be used to evaluate the adaptive bone remodeling after the implantation of the two different stems DXA analysis will be performed preoperatively of the hip and proximal tibia as baseline then again within the first postoperative week and subsequently at 3 months 6 months 1 year 2 years and 5 years The precision of the BMD measurements of the proximal femur will be estimated from double measurements of patients n12 included in the study
4 MB-RSA measurements of migration of the femoral component A MB-RSA system will be used a technique in which the position of the prosthesis is assessed by matching a virtual projection of a 3D-model of the prosthesis to the actual radiographic projection It does not require former times special implants with attached markers The patients will be x-rayed within the first postoperative week and subsequently at 3 months 6 months 1 year 2 years and 5 years using 2 fixed X-ray tubes with the patient in supine position and a uniplanar calibration cage will be used The precision of the measurements of migration will be estimated from sets of double X-rays of patients n12 included in the study
5 Patient reported outcome measurements It is planned also to ask the patients preoperatively and after 6 12 and 24 months to do a patient-reported outcome measurement using the Oxford Hip Score OHS
6 Long term follow-up 5-year follow-up including all above mentioned parameters will be performed
Calculations of sample size Migration RSA Several published RSA studies are available but none evaluating an uncemented Bi-Metric stem including data for the most clinically relevant migration between 1 and 2 years Quite a lot of RSA studies evaluating migration of both cemented and uncemented femoral stems have been published but most investigators give the variability of their RSA results as total range or standard error of mean We have decided for our sample size calculation to use the average standard deviation SD -for the migration after 2 years of follow-up from two previously published studies including data from one uncemented n22 and two cemented stems n82 where clear information regarding SD was available in the publication
Investigators performed the calculation using the parameter MTPM two years postoperatively using
Type I error 5 Type II error 15 MIREDIF 06 mm SD 069 mm Calculation resulted in a sample size of n 23 in each group
Bone remodeling DXA The expected prospective decrease in BMD of the proximal femur after insertion of an uncemented THA is most pronounced in Gruen zones 1 and 7 with decreases of respectively 13-21 and 10-31 In this study investigator intend to measure a significant difference MIREDIF in percentage changes in BMD between the two groups of 75 Even though several studies evaluating prospective changes in BMD around a femoral stem have been published investigator did not find a study with precise information of the SD of the percentages in BMD Thus investigator estimated a SD of the changes in BMD of 8 that could be used for calculating sample size in our study
Using
Type I error 5 Type II error 15 and MIREDIF 75 SD 8 Calculation resulted in a sample size of n 20 in each group Based upon the above sample size calculations for both RSA and DXA investigator have planned to include and randomize a total of 60 patients
This will secure a high statistical power of the study even if some of the participants should drop out during the study that can be kept even if the study is continued beyond 2 years of follow-up
Randomization Allocation to the Echo Bi-Metric group or control group Bi-Metric group is performed on a random basis block randomization with 10 in each block Randomization is done on the day of surgery with a closed non-transparent envelope opened in the operation theatre when the patient is ready for surgery
Due to visual difference of the two prostheses the surgeon and personnel present will know which of the prostheses the patient shall receive
Ethical considerations 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 It will be the investigators job to inform all patients until they completely understand all aspects of participation 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 circumstance
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
We do not expect the patients participating in the study to experience any specific side effects or complications related directly to the use of the two orthopedic implants A potential difference between the two prostheses is expected only to be measurable using very precise techniques such as DXA and RSA
Radiation dose to the patients from both RSA and DXA is low compared with conventional x-ray examinations The total accumulated radiation dose to a patient participating in all examinations during the study is estimated to be approximately 01 mSv
Tantalum has been used for more than 50 years and is a very biocompatible material Tantalum beads for RSA have been used especially in Sweden 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
Risks and inconveniences There will always be risks associated with operation This investigation will not add to the general risks of getting THA Patients participating must accept some inconvenience in terms of additional examinations and hence transportation to and from the hospitals
Adverse events Adverse events are defined as any harmful and unwanted event sign or symptom to occur in relation to this trial 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 THA 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 subjects
Existing 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
Operation All operations will be performed by 4 experienced hip surgeons from the Hip unit at the Department of Orthopedic Surgery Gentofte Hospital Gentofte Denmark Each of the surgeons performs approximately 120 THA-operations a year
Surgery is performed according to a standard procedure with a postero-lateral approach and following the manufacturers recommendations During surgery a minimum of 4 Tantalum markers 08mm are inserted in the bone of the proximal femur for defining the bone segment in the RSA analysis All patients receive the same uncemented hemispheric acetabular cup Exceed with a highly cross-linked polyethylene liner No local analgesic is injected Physiotherapy begins on the day of surgery and the patients will be mobilized with full weight-bearing using crutches All patients will get oral anticoagulants according to praxis of the department Xarelto until discharge and prophylactic antibiotics Dicloxacillin 2 g preoperatively and 1g x 2 postoperatively during the first 24 hours
Research plan
1 Clinical examination performed preoperatively and with follow-up after 1 and 2 years with evaluation of the hip function using the Harris Hip Score HHS HHS is a questionnaire in which the patients reveal their level of pain function mobility and range of motion
2 Conventional X-rays To evaluate possible aseptic loosening all patients will have a standardized full pelvic antero-posterior X-ray and a lateral X-ray with fixed magnification both preoperatively postoperatively at the 2 years follow-up visit and at the 5 years follow-up visit Radiolucent lines at the bone-implant interface and evidence of osteolysis will be measured on both recordings The standard Gruen zones will be used to record radiolucency surrounding the femoral component and the acetabular zones described by DeLee and Charnley will be used to record radiolucency surrounding the acetabular component The apparent thickness of the radiolucency within these zones will be recorded Evidence of osteolysis radiolucency 2mm thickness in the periprosthetic tissue of the acetabular or femoral component will be considered a failure
3 DXA analysis of the changes in BMD of the periprosthetic Gruen zones will be used to evaluate the adaptive bone remodeling after the implantation of the two different stems DXA analysis will be performed preoperatively of the hip and proximal tibia as baseline then again within the first postoperative week and subsequently at 3 months 6 months 1 year 2 years and 5 years The precision of the BMD measurements of the proximal femur will be estimated from double measurements of patients n12 included in the study
4 MB-RSA measurements of migration of the femoral component A MB-RSA system will be used a technique in which the position of the prosthesis is assessed by matching a virtual projection of a 3D-model of the prosthesis to the actual radiographic projection It does not require former times special implants with attached markers The patients will be x-rayed within the first postoperative week and subsequently at 3 months 6 months 1 year 2 years and 5 years using 2 fixed X-ray tubes with the patient in supine position and a uniplanar calibration cage will be used The precision of the measurements of migration will be estimated from sets of double X-rays of patients n12 included in the study
5 Patient reported outcome measurements It is planned also to ask the patients preoperatively and after 6 12 and 24 months to do a patient-reported outcome measurement using the Oxford Hip Score OHS
6 Long term follow-up 5-year follow-up including all above mentioned parameters will be performed
Calculations of sample size Migration RSA Several published RSA studies are available but none evaluating an uncemented Bi-Metric stem including data for the most clinically relevant migration between 1 and 2 years Quite a lot of RSA studies evaluating migration of both cemented and uncemented femoral stems have been published but most investigators give the variability of their RSA results as total range or standard error of mean We have decided for our sample size calculation to use the average standard deviation SD -for the migration after 2 years of follow-up from two previously published studies including data from one uncemented n22 and two cemented stems n82 where clear information regarding SD was available in the publication
Investigators performed the calculation using the parameter MTPM two years postoperatively using
Type I error 5 Type II error 15 MIREDIF 06 mm SD 069 mm Calculation resulted in a sample size of n 23 in each group
Bone remodeling DXA The expected prospective decrease in BMD of the proximal femur after insertion of an uncemented THA is most pronounced in Gruen zones 1 and 7 with decreases of respectively 13-21 and 10-31 In this study investigator intend to measure a significant difference MIREDIF in percentage changes in BMD between the two groups of 75 Even though several studies evaluating prospective changes in BMD around a femoral stem have been published investigator did not find a study with precise information of the SD of the percentages in BMD Thus investigator estimated a SD of the changes in BMD of 8 that could be used for calculating sample size in our study
Using
Type I error 5 Type II error 15 and MIREDIF 75 SD 8 Calculation resulted in a sample size of n 20 in each group Based upon the above sample size calculations for both RSA and DXA investigator have planned to include and randomize a total of 60 patients
This will secure a high statistical power of the study even if some of the participants should drop out during the study that can be kept even if the study is continued beyond 2 years of follow-up
Randomization Allocation to the Echo Bi-Metric group or control group Bi-Metric group is performed on a random basis block randomization with 10 in each block Randomization is done on the day of surgery with a closed non-transparent envelope opened in the operation theatre when the patient is ready for surgery
Due to visual difference of the two prostheses the surgeon and personnel present will know which of the prostheses the patient shall receive
Ethical considerations 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 It will be the investigators job to inform all patients until they completely understand all aspects of participation 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 circumstance
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
We do not expect the patients participating in the study to experience any specific side effects or complications related directly to the use of the two orthopedic implants A potential difference between the two prostheses is expected only to be measurable using very precise techniques such as DXA and RSA
Radiation dose to the patients from both RSA and DXA is low compared with conventional x-ray examinations The total accumulated radiation dose to a patient participating in all examinations during the study is estimated to be approximately 01 mSv
Tantalum has been used for more than 50 years and is a very biocompatible material Tantalum beads for RSA have been used especially in Sweden 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
Risks and inconveniences There will always be risks associated with operation This investigation will not add to the general risks of getting THA Patients participating must accept some inconvenience in terms of additional examinations and hence transportation to and from the hospitals
Adverse events Adverse events are defined as any harmful and unwanted event sign or symptom to occur in relation to this trial 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 THA 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 subjects
Existing 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?:
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