Total Hip ArthroplastyNCT06662981
The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty
A study testing preoparative information and education in people with Total Hip Arthroplasty, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
Preoperative patient information and education is an essential aspect of modern surgical care, particularly for patients undergoing total hip arthroplasty (THA). This prospective, randomized trial aims to assess the effects of structured preoperative education and information on clinical outcomes in patients… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- preoparative information and education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- 31 Oct 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- under 50 years old
- with reduced mental abilities
- with a presence of mental illness
- who have had previous hip surgery
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Sara Eleni Amprachim
Athens, Athens, 15124
KAT Hospital
Kifissia, Attica, 14561
About this study
Preoperative patient information and education is an essential aspect of modern surgical care, particularly for patients undergoing total hip arthroplasty (THA). This prospective, randomized trial aims to assess the effects of structured preoperative education and information on clinical outcomes in patients undergoing THA.
Read the detailed description
A total of 100 patients will be randomized into two groups: the intervention group (n = 50) receiving standardized preoperative information and education, and the control group (n = 50) receiving standard preoperative care without a formal educational component. Postoperative outcomes, including pain, functionality, mobility, length of hospital stay (LOS), health-related quality of life, anxiety and depression will be compared between the 2 groups.
- Conditions
- Total Hip Arthroplasty
- Being tested
- preoparative information and education
- Keywords
- preoperative information, preoperative education, total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoparative information and educationBehavioural
The intervention will include oral and written education about the operation, nursing and active participation in self-care. The intervention will take place in 3 phases: One week before THA, one day before THA after patient admission and postoperatively, before patient discharge. After a rough description of the operation, the anatomy and functionality of the joint will be presented, underlining the necessity of the operation. Instructions for recognizing and managing potential complications will be given. Patients will be informed about the appropriate post-operative walking aids, walking style, sitting up techniques, standing-up techniques, lying down techniques and getting in and out of the car. There will be a demonstration of muscle strengthening exercises, isometric quadriceps and gluteal exercises, Patients will also be informed about the necessity of prophylactic postoperative antithrombotic and antibiotic treatment.
| Study group | Role | What they receive |
|---|---|---|
| preoperative education | Experimental | The intervention will include oral and written education about the operation, nursing and active participation in self-care. The intervention will take place in 3 phases: One week before THA, one day before THA after patient admission and postoperatively, before patient discharge. After a rough description of the operation, the anatomy and functionality of the joint will be presented, underlining the necessity of the operation. Instructions for recognizing and managing potential complications will be given. Patients will be informed about the appropriate post-operative walking aids, walking style, sitting up techniques, standing-up techniques, lying down techniques and getting in and out of the car. There will be a demonstration of muscle strengthening exercises, isometric quadriceps and gluteal exercises, Patients will also be informed about the necessity of prophylactic postoperative antithrombotic and antibiotic treatment. Receives: Behavioral: preoparative information and education |
| no preoparative education (basic information) | No intervention | Patients will receive the standard preoperative care, which will not include formalized education beyond routine consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip pain and functionality
Assessed using modified Harris Hip Score (mHHS), validated in Greek, one day preoperatively and one month postoperatively
Measured: 30 days postoperatively
Length of Hospital Stay
Duration of hospitalization, measured in days
Measured: 30 days postoperatively
Anxiety and Depression
Assessed using the Hospital Anxiety and Depression Scale (HADS), validated in Greek, one day preoperatively, one day before discharge from hospital, and one month postoperatively
Measured: 30 days postoperatively
Health-related quality of life
Assessed using EQ-5D-5L index and EQ-5D-5L visual analog scale (VAS), validated in Greek one day preoperatively, one day before discharge from hospital, and one month postoperatively
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start31 Oct 2022
- Primary completion30 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARA ELENI AMPRACHIM, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662981
- Sponsor's protocol ID
- 11000
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be processed by the primary investigator
Publications
Amprachim SE, Vlamis J, Nikolaou VS, Pneumaticos SG. Role of Preoperative Information and Education of Patients Undergoing Total Hip Arthroplasty: A Narrative Review of the Literature. Cureus. 2024 Aug 3;16(8):e66094. doi: 10.7759/cureus.66094. eCollection 2024 Aug.
PubMed 39224727
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06662981
- Acronym / sponsor ID
- 11000
- Conditions
- Total Hip Arthroplasty
- Keywords
- preoperative information, preoperative education, total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative patient information and education is an essential aspect of modern surgical care, particularly for patients undergoing total hip arthroplasty (THA). This prospective, randomized trial aims to assess the effects of structured preoperative education and information on clinical outcomes in patients undergoing THA.
Detailed description
A total of 100 patients will be randomized into two groups: the intervention group (n = 50) receiving standardized preoperative information and education, and the control group (n = 50) receiving standard preoperative care without a formal educational component. Postoperative outcomes, including pain, functionality, mobility, length of hospital stay (LOS), health-related quality of life, anxiety and depression will be compared between the 2 groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative education | Experimental | Behavioral: preoparative information and educationThe intervention will include oral and written education about the operation, nursing and active participation in self-care. The intervention will take place in 3 phases: One week before THA, one day before THA after patient admission and postoperatively, before patient discharge. After a rough description of the operation, the anatomy and functionality of the joint will be presented, underlining the necessity of the operation. Instructions for recognizing and managing potential complications will be given. Patients will be informed about the appropriate post-operative walking aids, walking style, sitting up techniques, standing-up techniques, lying down techniques and getting in and out of the car. There will be a demonstration of muscle strengthening exercises, isometric quadriceps and gluteal exercises, Patients will also be informed about the necessity of prophylactic postoperative antithrombotic and antibiotic treatment. |
| no preoparative education (basic information) | No intervention | –Patients will receive the standard preoperative care, which will not include formalized education beyond routine consent. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- under 50 years old
- with reduced mental abilities
- with a presence of mental illness
- who have had previous hip surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoparative information and educationThe intervention will include oral and written education about the operation, nursing and active participation in self-care. The intervention will take place in 3 phases: One week before THA, one day before THA after patient admission and postoperatively, before patient discharge. After a rough description of the operation, the anatomy and functionality of the joint will be presented, underlining the necessity of the operation. Instructions for recognizing and managing potential complications will be given. Patients will be informed about the appropriate post-operative walking aids, walking style, sitting up techniques, standing-up techniques, lying down techniques and getting in and out of the car. There will be a demonstration of muscle strengthening exercises, isometric quadriceps and gluteal exercises, Patients will also be informed about the necessity of prophylactic postoperative antithrombotic and antibiotic treatment. | Behavioural | preoperative education |
Primary outcome
Hip pain and functionality
Time frame: 30 days postoperatively
Assessed using modified Harris Hip Score (mHHS), validated in Greek, one day preoperatively and one month postoperatively
Length of Hospital Stay
Time frame: 30 days postoperatively
Duration of hospitalization, measured in days
Anxiety and Depression
Time frame: 30 days postoperatively
Assessed using the Hospital Anxiety and Depression Scale (HADS), validated in Greek, one day preoperatively, one day before discharge from hospital, and one month postoperatively
Health-related quality of life
Time frame: 30 days postoperatively
Assessed using EQ-5D-5L index and EQ-5D-5L visual analog scale (VAS), validated in Greek one day preoperatively, one day before discharge from hospital, and one month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 39224727Amprachim SE, Vlamis J, Nikolaou VS, Pneumaticos SG. Role of Preoperative Information and Education of Patients Undergoing Total Hip Arthroplasty: A Narrative Review of the Literature. Cureus. 2024 Aug 3;16(8):e66094. doi: 10.7759/cureus.66094. eCollection 2024 Aug.
- Individual participant dataSharing planned: No. Patient data will be processed by the primary investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoparative information and education in people with Total Hip Arthroplasty, run by National and Kapodistrian University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip pain and functionality (time frame: 30 days postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.