Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06410079 |
| Other study ID # |
2023 A02666 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
September 8, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Société Française de chirurgie de la Hanche et du Genou |
| Contact |
Jean Marie PHILIPPEAU, MD |
| Phone |
024-012-7701 |
| Email |
jmphilippeau[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The literature is very scarce on Total Hip Arthroplasty(THA) 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, 100=normal) 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 and/or 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 (yes/no 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 Treatments/Procedures Any
treatment necessary for the routine care of the participant is authorized.
Prohibited Associated Treatments/Procedures 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 his/her 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. He/she will no longer be
followed up in the context of this protocol but will continue to receive the best
possible care given his/her state of health and the current state of knowledge.
Withdrawal is a decision by an included participant to exercise his/her right to
discontinue his/her participation in a research study, at any time during the follow-up,
without incurring any prejudice as a result and without having to justify
himself/herself.
Consent withdrawal is a decision by a participant to withdraw his/her participation in a
research study and to exercise his/her right to revoke his/her informed consent, at any
time during the follow-up and without incurring any prejudice as a result and without
having to justify himself/herself.
The investigator must assess whether it is possible to collect the variable on which the
primary endpoint is based at the time of withdrawal/withdrawal. Withdrawals/withdrawals
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
withdrawal/withdrawal must be documented in the observation notebook and in the
participants medical record.
A participant is considered lost to follow-up when he/she 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 himself/herself 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. And/or the cessation of
the administration of the tested product, if applicable, to all or part of the persons
already included in the research.
And/or 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.
1.2.3. 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
he/she has actually been included in the research even though he/she 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 R.1123-46 of the Public Health Code) Any harmful
manifestation occurring in a person who lends himself/herself 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 R.1123-46 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.
