Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410079
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-03
Brief Title:
Difference in Return to Sports Activity After Hip Arthroplasty by THR or Resurfacing
Sponsor:
Société Française de chirurgie de la Hanche et du Genou
Organization:
Société Française de chirurgie de la Hanche et du Genou
Study Overview
Official Title:
Do Patients Under the Age of 50 Resume Equivalent Physical Activity Levels After Conventional Total Hip Replacement or Hip Resurfacing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
PTH-50
Brief Summary:
This study aims to evaluate the return to activity in younger patients under 50 years old after undergoing either total hip replacement THR or hip resurfacing as performed in everyday practice This research will be observational meaning patients will not be randomly assigned to different treatment groups To objectively assess participents return to everyday professional and sports activities validated questionnaires will be sent to participents in addition to routine clinical practice The study will be prospective and comparative based on the type of prostheses used
In order to capture the current practices of surgeons performing THR in participents under 50 years old in France the study will be conducted at multiple centers across the country Since hip resurfacing is performed only in certain centers approximately half of the participating centers are experienced in this technique
Participents typically resume activity between 3 and 6 months after THR One year of post-operative follow-up allows for an accurate assessment of participents recovery unaffected by the surgery Participents physical activity levels will be evaluated using the UCLA Activity Scale developed by surgeons to assess the activity levels of patients undergoing hip and arthroplasty
In order to capture the current practices of surgeons performing THR in participents under 50 years old in France the study will be conducted at multiple centers across the country Since hip resurfacing is performed only in certain centers approximately half of the participating centers are experienced in this technique
Participents typically resume activity between 3 and 6 months after THR One year of post-operative follow-up allows for an accurate assessment of participents recovery unaffected by the surgery Participents physical activity levels will be evaluated using the UCLA Activity Scale developed by surgeons to assess the activity levels of patients undergoing hip and arthroplasty
Detailed Description:
The literature is very scarce on Total Hip ArthroplastyTHA in young patients To date there is no comparison on activity resumption based on prosthesis type on a national scale Total Hip Arthrosplaty THA has been subject to a French registry since 2015 for patients operated by resurfacing but no analysis of prosthesis wear has been conducted A retrospective study with a follow-up exceeding 10 years is required to address this point and is the subject of another ongoing research Resurfacing allows the preservation of anatomical elements but remains limited in France The primary cause of THA revision identified is periprosthetic fracture After resurfacing a THA is performed while after THA only revision THA is possible but entails a longer operative time with a significant financial impact
The aim of the research is to compare the level of physical activity at 1 year follow-up according to the type of prostheses in adult patients under 50 It is part of presenting the practices of THA in young individuals in France during a symposium organized by the SFHG for 2025
Research Hypothesis Regardless of the type of implants used total hip arthroplasty yields excellent results in young patients with early resumption of activities including sports A meta-analysis of 11 studies comprising 2297 patients shows that 70-90 of patients resumed sports activities within 6-12 months post-THA A more recent systematic literature review confirms that 82 of patients have resumed sports activity on average at 6 months
The research hypothesis is that there is no difference in physical activity at 1 year between patients operated with different types of prostheses including dual mobility
Justification of Methodological Choices Given the number of young patients undergoing THA per year in France and considering a 5 margin of error and a 95 confidence interval the sample size to be included is 500 patients
A retrospective monocentric study is proposed given the scarcity of data in this young population It will include adult patients under 50 operated on from 2015 to 2020 Participants will be divided into three groups according to the type of prosthesis hip resurfacing soft-hard THA and hard-hard THA
A comprehensive review of the medical records will be conducted to collect data
Physical activity will be assessed at 1 year post-surgery using the International Physical Activity Questionnaire IPAQ a reliable and validated tool The primary outcome is the level of physical activity at 1 year and secondary outcomes include functional scores HHS WOMAC complications and prosthesis survival rate
Ethical Considerations This study complies with the ethical principles outlined in the Declaration of Helsinki Participant data will be anonymized to ensure confidentiality Informed consent will be obtained from all participants
Expected Results It is expected that there will be no significant difference in physical activity level at 1 year between patients operated with different types of prostheses The results will provide valuable information on the optimal type of prosthesis for young patients undergoing THA and contribute to improving patient outcomes and satisfaction
Primary objective The primary objective of the research is to compare the level of physical activity of participants at 1 year between those operated by resurfacing and those operated for a THA taking into account their usual level
Secondary objectives
The secondary objectives of the study are to
1 Compare physical and professional activity
Compare the level of physical activity of patients at 1 year between the 4 studied prosthesis groups taking into account their usual level
Compare the level of physical activity at 1 year to the preoperative level between the 2 groups and then between the 4 prosthesis groups
Compare the change in physical activity level between the 2 groups and then between the 4 prosthesis groups in relation to usual level and preoperative level
Compare the time to return to physical and sporting activity in the year following hip arthroplasty
Compare the time to return to usual professional activity
Evaluate the quality of return to activity
Evaluate early complications after total hip arthroplasty
Compare the participants postoperative experience
Analyze the factors influencing the return to physical activity
Describe the type of implant surgical approach and clinical parameters in each group Evaluation criteria Main evaluation criterion The main evaluation criterion is the 1-year difference in the UCLA score measuring participants physical activity in relation to their usual level for the resurfacing group and for all THAs
Secondary evaluation criteria
The secondary evaluation criteria corresponding to the secondary objectives are
1 For each prosthesis group
The 1-year difference in the UCLA score measuring the participants physical activity in relation to their usual level
The 1-year difference in the UCLA score measuring physical activity in relation to the preoperative level
The UCLA score at different times usual level preoperative 6 weeks 3 months 6 months 12 months
The time to return to activities and sports
The time to return to usual professional activity
The quality of return to activity is evaluated by the Oxford hip functional scores
Complications and the rate of revision surgery if applicable Participants experience is measured by the SHV Subjective Hip Value Score and the Forgotten Hip Score 100 100normal at all study visits compared to the preoperative value
The factors influencing the time to return to physical activity at the usual level in the year following prosthetic surgery taken into account for the analysis are patient-related parameters rehabilitation or not age physical activity medical history including inflammatory diseases surgery-related parameters type of implant surgical approach and length of hospitalization
The type of implant surgical approach and clinical outcomes Research design Research scheme Observational non-inferiority non-randomized prospective multicenter national study
Patients operated on the hip will be classified into 4 groups according to the type of prosthesis
The resurfacing group
The THA group hard-soft
The THA group dual mobility
The THA group hard-hard Methods to limit bias Choice of centers Inclusion control Research Procedure The research procedure consists of collecting data from the medical records of patients followed in the context of current practice demographics anthropometry comorbidities medical history etiology surgery-related data first mobilization length of stay discharge type and duration of rehabilitation In addition to current practice patients will be asked to complete questionnaires on their return to activity daily professional and sports with a systematic collection of postoperative events and any complications No medical procedures or visits have been added in the context of this research
Questionnaires Assessing Physical Activity The patients level of activity is assessed by the Devane score it assesses work-related andor sports activities It is a score that gives an overall assessment of the participants level of activity or sedentary lifestyle rather than their actual sports practice The score ranges from 1 to 5 depending on the participants answers with 5 corresponding to the most intense activities
The participants pre-operative sports profile is assessed by 3 questions asked to the participant
Post-operative return to sports activity is assessed by 1 question yesno with 4 modalities to explain the reason for no If the participant has resumed sports activity 4 additional questions are asked about the frequency per week whether it is the same activity whether it is at the same level as before the intervention and the type of activity
The participant level of physical activity is assessed by the UCLA score from the University of California Los Angeles This scale was originally developed by surgeons to assess the physical activity levels of patients who had undergone hip and knee arthroplasty It is a 10-level single-item scale ranging from 10 for a patient who regularly participates in impact sports to 1 for a patient who is completely inactive dependent on others and unable to leave their home
Questionnaires Assessing Hip Function
The functional results of the hip are assessed by the participant with the following questionnaires
The Oxford Hip Score OHS-12 Delaunay et al 2009 questionnaire is composed of 12 questions It measures pain on 6 items and hip function on 6 items in relation to activities of daily living such as walking the ability to dress and sleep disturbances Each question has 5 possible answers Each corresponds to a value of 0 highest severity to 4 total or almost total absence of symptoms The sum of the answers to the questions is normalized on a scale between 0 and 100
The SHV Subjective Hip Value questionnaire is an analog evaluation scale coded from 0 to 100 Normal hip
The FJS Forgotten Joint Score HIP or Forgotten Hip Score is set at 100 with 100 corresponding to a normal hip
Other Questions Asked of the Patient Patients will be asked questions about bleeding swelling and wound healing in the days and weeks after surgery Immediate complications and reoperation if applicable will be collected
In addition patients will be asked about the duration of work stoppage and sports cessation before and after surgery
Treatments and Associated Procedures Authorized Associated TreatmentsProcedures Any treatment necessary for the routine care of the participant is authorized
Prohibited Associated TreatmentsProcedures No associated treatment or procedure is prohibited during the study
Conduct of the Research Research Schedule Duration of the inclusion period 6 months Duration of participation for each participant maximum 15 months Total duration of the research 21 months
Visit 1
Visit 1 is the inclusion visit corresponding to the pre-operative visit with the surgeon It is conducted by the investigator physician and usually takes place between 3 and 1 month before the surgical procedure D0 This visit includes
Providing the information sheet and explaining the research Verifying all eligibility criteria Obtaining the participants non-opposition by the physician Collecting demographic and anthropometric data age sex height weight Collecting comorbidities and history of the hip and spine etiology Visit 2
Visit 2 corresponds to the sending of questionnaires by email to the participant 14 days before the surgical procedure D0 Visit 3
Description of profession and activities 5 min Degree of activity Devane score 1 min Patients sport profile 1 min Usual UCLA activity level and preoperative UCLA activity level 3 min Self-questionnaires Oxford questionnaire 20 min Participant feelings by SHV and hip awareness FJS HIP 3 min Collection of the duration of sports and professional cessation before surgery 2 min A reminder for the primary endpoint is planned until the day before the procedure
Visit 3 Visit 3 corresponds to the hip surgery by resurfacing or total prosthesis placement according to the surgeons current practice
Surgical data will be collected such as the operated side surgical approach type of anesthesia duration of the procedure type of prosthesis and friction couple surgical procedure and any immediate complications
Visit 4 Visit 4 corresponds to the collection of postoperative data from the participant during the postoperative period between the surgical procedure D0 Visit 3 and the postoperative visit at 3 months Visit 5
The following data will be collected during hisher hospital stay and then by email upon discharge
The first day of postoperative mobilization discharge location prescription of rehabilitation sessions Bleeding at D1 D3 D7 Edema at D21 and D42 Healing at D21 and D42 Participant feelings by the SHV at D28 D42 D70 UCLA physical activity level questionnaire at D42 Return to work at D28 D35 D42 D70 Surgical complications and any reoperation throughout follow-up Visit 5
Visit 5 corresponds to the collection of data at the 3-month postoperative visit
Postoperative UCLA activity level Oxford questionnaire sent 5 days before at D85-10min Participants feelings SHV and hip awareness FJS Hip Edema Surgical complications and any reoperation Return to work and sports activities Collection of SAEs Visit 6
Visit 6 corresponds to the collection of data at the 6-month postoperative visit
Postoperative UCLA activity level Oxford questionnaire sent 5 days before Visit 6 at D175-10min Participant feelings SHV and hip awareness FJS Hip Surgical complications and any reoperation Return to work and sports activities End-of-Study Visit or Visit 7
Visit 7 corresponds to the collection of data at the 12-month postoperative visit
Postoperative UCLA activity level Oxford questionnaire sent 5 days before Visit 7 at D356-10min Participant feelings SHV and hip awareness FJS Hip Surgical complications and any reoperation Return to work and sports activities Postoperative duration of sports and professional cessation Collection of SAEs Study Termination Rules and Protocol Deviations Withdrawal Consent Withdrawal and Lost to Follow-up A participant who no longer wishes to participate in this research particularly in case of withdrawal or consent withdrawal may do so at any time for any reason Heshe will no longer be followed up in the context of this protocol but will continue to receive the best possible care given hisher state of health and the current state of knowledge
Withdrawal is a decision by an included participant to exercise hisher right to discontinue hisher participation in a research study at any time during the follow-up without incurring any prejudice as a result and without having to justify himselfherself
Consent withdrawal is a decision by a participant to withdraw hisher participation in a research study and to exercise hisher right to revoke hisher informed consent at any time during the follow-up and without incurring any prejudice as a result and without having to justify himselfherself
The investigator must assess whether it is possible to collect the variable on which the primary endpoint is based at the time of withdrawalwithdrawal Withdrawalswithdrawals must be promptly notified to the coordinating investigator center the sponsor and the data management and methodology center The reasons if known and the date of withdrawalwithdrawal must be documented in the observation notebook and in the participants medical record
A participant is considered lost to follow-up when heshe stops the follow-up planned in the protocol for no reason known to the investigator so that the data collection cannot be carried out as planned In case of a lost-to-follow-up subject the investigator will make every effort to get back in touch with the person
The observation notebook will be completed until the end of the study by documenting the reason for leaving
Research Termination Rules End of research or planned termination of research end of participation of the last person who lends himselfherself to the research also called last visit of the last participant included in the research
When the research has reached its planned term planned termination the end of the research must be declared to the ANSM and the CPP within 90 days
Early termination of research the clinical research is stopped definitively in advance This is the case in particular when the sponsor decides
Not to start the research despite the favorable opinion of a CPP Not to resume the research after having temporarily interrupted it or after its suspension by the ANSM
When the research is stopped definitively in advance the end of the research must be declared to the ANSM within 15 days indicating the reasons for this stop
Temporary suspension of research the temporary suspension of a clinical research consists of
The cessation of the inclusion of new persons in this research Andor the cessation of the administration of the tested product if applicable to all or part of the persons already included in the research
Andor the cessation of the acts provided for in the research protocol Any decision by the sponsor to temporarily suspend the research must be immediately informed to the ANSM and the CPP concerned and in a second step and within a maximum of 15 calendar days following the date of this suspension a request for authorization for a substantial modification concerning this temporary suspension submitted to the ANSM and a request for an opinion to the CPP concerned
123 Premature Terminations The investigator may temporarily or permanently discontinue a participants contribution to the study for any reason that would best serve the participants interests particularly in the event of an SAE These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current knowledge
The performance of a THP on the other side during the study or the occurrence of an SAE compromising the evaluation of the primary endpoint is a reason for premature termination
The study provides for early exit of participants who are in either of these situations These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current Premature Terminations The performance of a THP on the other side during the study or the occurrence of an SAE compromising the evaluation of the primary endpoint is a reason for premature termination
The study provides for early exit of participants who are in either of these situations These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current knowledge
For all premature study withdrawals the investigator must document the reasons as completely as possible The observation notebook will be completed until the end of the study
The study may be interrupted prematurely in the event of unexpected adverse events SAEs requiring a review of the medical strategies profile Similarly unforeseen events or new information relating to medical strategies may lead the sponsor to prematurely interrupt the study
Participants Included in Error A participant is considered to be included in error when heshe has actually been included in the research even though heshe did not meet all the eligibility criteria Participants included in error must be discussed They must continue to be followed up as planned by the protocol until a decision has been made by the sponsor in agreement with the study coordinating investigator
Protocol Deviations Deviations must be documented by the investigator A protocol deviation may be discussed between the investigator and the sponsor Even in the event of a protocol deviation the participants follow-up must be conducted until the end of the protocol
Definitions Adverse Event Article R1123-46 of the Public Health Code Any harmful manifestation occurring in a person who lends himselfherself to research involving the human person whether or not this manifestation is related to the research or the product on which the research is carried out
Serious Adverse Event or Effect Article R1123-46 of the Public Health Code and ICH E2B Guide
Any adverse event that
Certain circumstances requiring hospitalization do not fall under the severity criterion of hospitalization such as
admission for social or administrative reasons hospitalization predefined by the protocol hospitalization for medical or surgical treatment scheduled before the research day hospital stay Adverse events likely to be related to a drug or product mentioned in Article R 5121-150 to be declared to the Regional Pharmacovigilance Center CRPV on which it depends
Incidents or risks of incidents resulting from the use of a medical device to be reported to the local Matériovigilance correspondent
Monitoring and Reporting of Serious Adverse Events The study was non-interventional no serious adverse events are expected related to this study
The aim of the research is to compare the level of physical activity at 1 year follow-up according to the type of prostheses in adult patients under 50 It is part of presenting the practices of THA in young individuals in France during a symposium organized by the SFHG for 2025
Research Hypothesis Regardless of the type of implants used total hip arthroplasty yields excellent results in young patients with early resumption of activities including sports A meta-analysis of 11 studies comprising 2297 patients shows that 70-90 of patients resumed sports activities within 6-12 months post-THA A more recent systematic literature review confirms that 82 of patients have resumed sports activity on average at 6 months
The research hypothesis is that there is no difference in physical activity at 1 year between patients operated with different types of prostheses including dual mobility
Justification of Methodological Choices Given the number of young patients undergoing THA per year in France and considering a 5 margin of error and a 95 confidence interval the sample size to be included is 500 patients
A retrospective monocentric study is proposed given the scarcity of data in this young population It will include adult patients under 50 operated on from 2015 to 2020 Participants will be divided into three groups according to the type of prosthesis hip resurfacing soft-hard THA and hard-hard THA
A comprehensive review of the medical records will be conducted to collect data
Physical activity will be assessed at 1 year post-surgery using the International Physical Activity Questionnaire IPAQ a reliable and validated tool The primary outcome is the level of physical activity at 1 year and secondary outcomes include functional scores HHS WOMAC complications and prosthesis survival rate
Ethical Considerations This study complies with the ethical principles outlined in the Declaration of Helsinki Participant data will be anonymized to ensure confidentiality Informed consent will be obtained from all participants
Expected Results It is expected that there will be no significant difference in physical activity level at 1 year between patients operated with different types of prostheses The results will provide valuable information on the optimal type of prosthesis for young patients undergoing THA and contribute to improving patient outcomes and satisfaction
Primary objective The primary objective of the research is to compare the level of physical activity of participants at 1 year between those operated by resurfacing and those operated for a THA taking into account their usual level
Secondary objectives
The secondary objectives of the study are to
1 Compare physical and professional activity
Compare the level of physical activity of patients at 1 year between the 4 studied prosthesis groups taking into account their usual level
Compare the level of physical activity at 1 year to the preoperative level between the 2 groups and then between the 4 prosthesis groups
Compare the change in physical activity level between the 2 groups and then between the 4 prosthesis groups in relation to usual level and preoperative level
Compare the time to return to physical and sporting activity in the year following hip arthroplasty
Compare the time to return to usual professional activity
Evaluate the quality of return to activity
Evaluate early complications after total hip arthroplasty
Compare the participants postoperative experience
Analyze the factors influencing the return to physical activity
Describe the type of implant surgical approach and clinical parameters in each group Evaluation criteria Main evaluation criterion The main evaluation criterion is the 1-year difference in the UCLA score measuring participants physical activity in relation to their usual level for the resurfacing group and for all THAs
Secondary evaluation criteria
The secondary evaluation criteria corresponding to the secondary objectives are
1 For each prosthesis group
The 1-year difference in the UCLA score measuring the participants physical activity in relation to their usual level
The 1-year difference in the UCLA score measuring physical activity in relation to the preoperative level
The UCLA score at different times usual level preoperative 6 weeks 3 months 6 months 12 months
The time to return to activities and sports
The time to return to usual professional activity
The quality of return to activity is evaluated by the Oxford hip functional scores
Complications and the rate of revision surgery if applicable Participants experience is measured by the SHV Subjective Hip Value Score and the Forgotten Hip Score 100 100normal at all study visits compared to the preoperative value
The factors influencing the time to return to physical activity at the usual level in the year following prosthetic surgery taken into account for the analysis are patient-related parameters rehabilitation or not age physical activity medical history including inflammatory diseases surgery-related parameters type of implant surgical approach and length of hospitalization
The type of implant surgical approach and clinical outcomes Research design Research scheme Observational non-inferiority non-randomized prospective multicenter national study
Patients operated on the hip will be classified into 4 groups according to the type of prosthesis
The resurfacing group
The THA group hard-soft
The THA group dual mobility
The THA group hard-hard Methods to limit bias Choice of centers Inclusion control Research Procedure The research procedure consists of collecting data from the medical records of patients followed in the context of current practice demographics anthropometry comorbidities medical history etiology surgery-related data first mobilization length of stay discharge type and duration of rehabilitation In addition to current practice patients will be asked to complete questionnaires on their return to activity daily professional and sports with a systematic collection of postoperative events and any complications No medical procedures or visits have been added in the context of this research
Questionnaires Assessing Physical Activity The patients level of activity is assessed by the Devane score it assesses work-related andor sports activities It is a score that gives an overall assessment of the participants level of activity or sedentary lifestyle rather than their actual sports practice The score ranges from 1 to 5 depending on the participants answers with 5 corresponding to the most intense activities
The participants pre-operative sports profile is assessed by 3 questions asked to the participant
Post-operative return to sports activity is assessed by 1 question yesno with 4 modalities to explain the reason for no If the participant has resumed sports activity 4 additional questions are asked about the frequency per week whether it is the same activity whether it is at the same level as before the intervention and the type of activity
The participant level of physical activity is assessed by the UCLA score from the University of California Los Angeles This scale was originally developed by surgeons to assess the physical activity levels of patients who had undergone hip and knee arthroplasty It is a 10-level single-item scale ranging from 10 for a patient who regularly participates in impact sports to 1 for a patient who is completely inactive dependent on others and unable to leave their home
Questionnaires Assessing Hip Function
The functional results of the hip are assessed by the participant with the following questionnaires
The Oxford Hip Score OHS-12 Delaunay et al 2009 questionnaire is composed of 12 questions It measures pain on 6 items and hip function on 6 items in relation to activities of daily living such as walking the ability to dress and sleep disturbances Each question has 5 possible answers Each corresponds to a value of 0 highest severity to 4 total or almost total absence of symptoms The sum of the answers to the questions is normalized on a scale between 0 and 100
The SHV Subjective Hip Value questionnaire is an analog evaluation scale coded from 0 to 100 Normal hip
The FJS Forgotten Joint Score HIP or Forgotten Hip Score is set at 100 with 100 corresponding to a normal hip
Other Questions Asked of the Patient Patients will be asked questions about bleeding swelling and wound healing in the days and weeks after surgery Immediate complications and reoperation if applicable will be collected
In addition patients will be asked about the duration of work stoppage and sports cessation before and after surgery
Treatments and Associated Procedures Authorized Associated TreatmentsProcedures Any treatment necessary for the routine care of the participant is authorized
Prohibited Associated TreatmentsProcedures No associated treatment or procedure is prohibited during the study
Conduct of the Research Research Schedule Duration of the inclusion period 6 months Duration of participation for each participant maximum 15 months Total duration of the research 21 months
Visit 1
Visit 1 is the inclusion visit corresponding to the pre-operative visit with the surgeon It is conducted by the investigator physician and usually takes place between 3 and 1 month before the surgical procedure D0 This visit includes
Providing the information sheet and explaining the research Verifying all eligibility criteria Obtaining the participants non-opposition by the physician Collecting demographic and anthropometric data age sex height weight Collecting comorbidities and history of the hip and spine etiology Visit 2
Visit 2 corresponds to the sending of questionnaires by email to the participant 14 days before the surgical procedure D0 Visit 3
Description of profession and activities 5 min Degree of activity Devane score 1 min Patients sport profile 1 min Usual UCLA activity level and preoperative UCLA activity level 3 min Self-questionnaires Oxford questionnaire 20 min Participant feelings by SHV and hip awareness FJS HIP 3 min Collection of the duration of sports and professional cessation before surgery 2 min A reminder for the primary endpoint is planned until the day before the procedure
Visit 3 Visit 3 corresponds to the hip surgery by resurfacing or total prosthesis placement according to the surgeons current practice
Surgical data will be collected such as the operated side surgical approach type of anesthesia duration of the procedure type of prosthesis and friction couple surgical procedure and any immediate complications
Visit 4 Visit 4 corresponds to the collection of postoperative data from the participant during the postoperative period between the surgical procedure D0 Visit 3 and the postoperative visit at 3 months Visit 5
The following data will be collected during hisher hospital stay and then by email upon discharge
The first day of postoperative mobilization discharge location prescription of rehabilitation sessions Bleeding at D1 D3 D7 Edema at D21 and D42 Healing at D21 and D42 Participant feelings by the SHV at D28 D42 D70 UCLA physical activity level questionnaire at D42 Return to work at D28 D35 D42 D70 Surgical complications and any reoperation throughout follow-up Visit 5
Visit 5 corresponds to the collection of data at the 3-month postoperative visit
Postoperative UCLA activity level Oxford questionnaire sent 5 days before at D85-10min Participants feelings SHV and hip awareness FJS Hip Edema Surgical complications and any reoperation Return to work and sports activities Collection of SAEs Visit 6
Visit 6 corresponds to the collection of data at the 6-month postoperative visit
Postoperative UCLA activity level Oxford questionnaire sent 5 days before Visit 6 at D175-10min Participant feelings SHV and hip awareness FJS Hip Surgical complications and any reoperation Return to work and sports activities End-of-Study Visit or Visit 7
Visit 7 corresponds to the collection of data at the 12-month postoperative visit
Postoperative UCLA activity level Oxford questionnaire sent 5 days before Visit 7 at D356-10min Participant feelings SHV and hip awareness FJS Hip Surgical complications and any reoperation Return to work and sports activities Postoperative duration of sports and professional cessation Collection of SAEs Study Termination Rules and Protocol Deviations Withdrawal Consent Withdrawal and Lost to Follow-up A participant who no longer wishes to participate in this research particularly in case of withdrawal or consent withdrawal may do so at any time for any reason Heshe will no longer be followed up in the context of this protocol but will continue to receive the best possible care given hisher state of health and the current state of knowledge
Withdrawal is a decision by an included participant to exercise hisher right to discontinue hisher participation in a research study at any time during the follow-up without incurring any prejudice as a result and without having to justify himselfherself
Consent withdrawal is a decision by a participant to withdraw hisher participation in a research study and to exercise hisher right to revoke hisher informed consent at any time during the follow-up and without incurring any prejudice as a result and without having to justify himselfherself
The investigator must assess whether it is possible to collect the variable on which the primary endpoint is based at the time of withdrawalwithdrawal Withdrawalswithdrawals must be promptly notified to the coordinating investigator center the sponsor and the data management and methodology center The reasons if known and the date of withdrawalwithdrawal must be documented in the observation notebook and in the participants medical record
A participant is considered lost to follow-up when heshe stops the follow-up planned in the protocol for no reason known to the investigator so that the data collection cannot be carried out as planned In case of a lost-to-follow-up subject the investigator will make every effort to get back in touch with the person
The observation notebook will be completed until the end of the study by documenting the reason for leaving
Research Termination Rules End of research or planned termination of research end of participation of the last person who lends himselfherself to the research also called last visit of the last participant included in the research
When the research has reached its planned term planned termination the end of the research must be declared to the ANSM and the CPP within 90 days
Early termination of research the clinical research is stopped definitively in advance This is the case in particular when the sponsor decides
Not to start the research despite the favorable opinion of a CPP Not to resume the research after having temporarily interrupted it or after its suspension by the ANSM
When the research is stopped definitively in advance the end of the research must be declared to the ANSM within 15 days indicating the reasons for this stop
Temporary suspension of research the temporary suspension of a clinical research consists of
The cessation of the inclusion of new persons in this research Andor the cessation of the administration of the tested product if applicable to all or part of the persons already included in the research
Andor the cessation of the acts provided for in the research protocol Any decision by the sponsor to temporarily suspend the research must be immediately informed to the ANSM and the CPP concerned and in a second step and within a maximum of 15 calendar days following the date of this suspension a request for authorization for a substantial modification concerning this temporary suspension submitted to the ANSM and a request for an opinion to the CPP concerned
123 Premature Terminations The investigator may temporarily or permanently discontinue a participants contribution to the study for any reason that would best serve the participants interests particularly in the event of an SAE These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current knowledge
The performance of a THP on the other side during the study or the occurrence of an SAE compromising the evaluation of the primary endpoint is a reason for premature termination
The study provides for early exit of participants who are in either of these situations These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current Premature Terminations The performance of a THP on the other side during the study or the occurrence of an SAE compromising the evaluation of the primary endpoint is a reason for premature termination
The study provides for early exit of participants who are in either of these situations These participants will no longer be followed up in the context of this protocol but will continue to receive the best possible care given their state of health and current knowledge
For all premature study withdrawals the investigator must document the reasons as completely as possible The observation notebook will be completed until the end of the study
The study may be interrupted prematurely in the event of unexpected adverse events SAEs requiring a review of the medical strategies profile Similarly unforeseen events or new information relating to medical strategies may lead the sponsor to prematurely interrupt the study
Participants Included in Error A participant is considered to be included in error when heshe has actually been included in the research even though heshe did not meet all the eligibility criteria Participants included in error must be discussed They must continue to be followed up as planned by the protocol until a decision has been made by the sponsor in agreement with the study coordinating investigator
Protocol Deviations Deviations must be documented by the investigator A protocol deviation may be discussed between the investigator and the sponsor Even in the event of a protocol deviation the participants follow-up must be conducted until the end of the protocol
Definitions Adverse Event Article R1123-46 of the Public Health Code Any harmful manifestation occurring in a person who lends himselfherself to research involving the human person whether or not this manifestation is related to the research or the product on which the research is carried out
Serious Adverse Event or Effect Article R1123-46 of the Public Health Code and ICH E2B Guide
Any adverse event that
Certain circumstances requiring hospitalization do not fall under the severity criterion of hospitalization such as
admission for social or administrative reasons hospitalization predefined by the protocol hospitalization for medical or surgical treatment scheduled before the research day hospital stay Adverse events likely to be related to a drug or product mentioned in Article R 5121-150 to be declared to the Regional Pharmacovigilance Center CRPV on which it depends
Incidents or risks of incidents resulting from the use of a medical device to be reported to the local Matériovigilance correspondent
Monitoring and Reporting of Serious Adverse Events The study was non-interventional no serious adverse events are expected related to this study
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