Arthritis of HipNCT04928924
Immediate Post-THA Functional Assessment
An observational study of Arthritis of Hip, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial summary
The objective of this study is to investigate the feasibility of functional 3D biomechanical assessment and EMG analysis of gait and a sit to stand tasks in the immediate post-operative phase following total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2021to Apr 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred to the Golden Jubilee National Hospital for total hip replacement.
Who may be able to join
- Patients suitable for posterolateral approach total hip arthroplasty
- Able to give informed consentAble to return to study site for follow-up
- BMI under 35
Who cannot join
- Previous hip procedure in the previous twelve months
- Previous knee surgery other than arthroscopy and medial menisectomy in the last twelve months
- Symptomatic foot, knee, contralateral hip or spinal pathology
- Any medical condition limiting normal ambulation e.g. stroke, Parkinsons disease, severe lymphedema, advanced cardiac disease
- Unable to read and understand English and follow verbal and visual instructions unless they can bring a relative or friend to all study assessments to act as a translator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, G81 4DY
About this study
Official title: Functional Biomechanical Analysis in Immediate Post-Operative Period Following Total Hip Arthroplasty - A Pilot Study
The objective of this study is to investigate the feasibility of functional 3D biomechanical assessment and EMG analysis of gait and a sit to stand tasks in the immediate post-operative phase following total hip arthroplasty.
Read the detailed description
Functional recovery is often an important priority for patients undergoing total hip arthroplasty (THA) and it is thought that abnormal biomechanics may be an obstacle to full recovery of physical function. While there has been extensive research on the biomechanics of gait and other activities of daily living following THA, the earliest reported post-operative assessment of function using 3D motion analysis for kinematics and kinetics has been at 6 weeks post-surgery. There is a paucity of data from the immediate post-operative phase prior to patient discharge from hospital.
In recent years there has been an increase in initiatives such as fast-track or enhanced post-operative recovery programs following joint arthroplasty, with the aim being an early return to function and shorter hospital length of stay whilst maintaining the low morbidity and mortality and high satisfaction rates typically associated with THA. There has also been continued research and developments on improving the THA procedure and while initial focus on improving THA surgery centred on implant design, materials and fixation to bone, there has been increased attention to surgical approach. In the last 10 years the use of minimally invasive surgical techniques has become more widespread due to the potential reported benefits. These include a shorter incision length, reduced muscle damage, reduced pain and less bleeding. When combined, these benefits may lead to reduced length of hospital stay and earlier return to function.
With so much focus centred on early return to function, there is a need to objectively measure function in the immediate post-operative phase. This would allow us to evaluate the effect of minimally invasive surgical approaches and enhanced recovery programs, which are primarily centred on early recovery from surgery. The use of 3D motion capture technology allows for accurate assessment of joint movement in three planes during dynamic movements and has been used extensively in the evaluation of function in patients with significant hip pathology before and after total hip arthroplasty. As aforementioned, to date the earliest post-operative motion analysis has been at 6 weeks after THA. Similarly, the earliest reported time point for muscle activation analysis using EMG is 6 weeks post THA. The aim of this study is assess the feasibility of 3D motion analysis including EMG in the immediate post-operative phase following THA in a hospital which incorporates an Enhanced Recovery After Surgery (ERAS) program as part of routine clinical care. This pilot project will guide development of future protocols which require early post-operative 3D biomechanical analysis.
For the purposes of this study the investigators define the immediate post-operative time point as the day the patient is discharged from the inpatient rehabilitation team and therefore deemed "safe" to mobilise independently by the ward physiotherapists.
Subject recruitment and retention will be closely monitored throughout the trial, allowing us to measure recruitment and dropout rates. Where possible, reasons for declining participation in the study and reasons for dropout will be documented. The ability of the patients to perform study related assessments will be recorded in addition to the reason for them being unable to perform the task, this will be done via a questionnaire that patients will complete at the end of each 3D biomechanical assessment session.
Patients will be asked to attend a biomechanical testing session before their surgery. After surgery they will follow standard aftercare, and on the day of discharge from the inpatient physiotherapy team they will be asked to attend the second biomechanical testing session. The third and fourth sessions will be on day three and day seven post-surgery, and the final session will take place when they return to the hospital for their standard three month follow up with the arthroplasty team. At the end of the three month visit, their involvement in the study will be complete.
Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers and surface electrodes will be attached to specific locations on the body using suitable double sided tape which can be tracked by a number of infrared cameras. participants will be asked to perform the following tasks; walking, sit-to-stand and stand-to-sit. Each task will be performed at least three times to enable the collection of three good sets of data. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces.
- Conditions
- Arthritis of Hip
- Being tested
- Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, biomechanical assessment, gait analysis, movement analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
We will be observing patients who have undergone surgical replacement of arthritic hip with an implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient adherence to study procedures
Patients ability to attend for follow up appointments and carry out study specific biomechanical assessments
Measured: 3 months
Secondary outcomes (9)
Eligible patients
Number of suitable patients per consultant per month
Measured: 1 year
Recruitment rate
Percentage of eligible patients recruited
Measured: 1 year
Loss to follow up
Number of patients who choose to withdraw/ are lost to follow up
Measured: 3 months
Hip angles during walking
Hip angles of movement collected using clinical movement analysis
Measured: 3 months
Hip loads during walking
Hip loading collected using clinical movement analysis
Measured: 3 months
Hip angles during sit to stand to sit
Hip angles of movement collected using clinical movement analysis
Measured: 3 months
Hip loads during sit to stand to sit
Hip loading collected using clinical movement analysis
Measured: 3 months
Muscle activation patterns walking
Hip muscle activation during level walking
Measured: 3 months
Muscle activation patterns stand to sit to stand
Hip muscle activation during stand to sit to stand
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start26 Apr 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Arthritis of HipStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- Stryker GI Ltd.
- Responsible party
- Sponsor
- Investigators
- Nicholas Ohly, MBBS, FRCSEd, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928924
- Sponsor's protocol ID
- 19-07
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21.
PubMed 29783896Lubbeke A, Katz JN, Perneger TV, Hoffmeyer P. Primary and revision hip arthroplasty: 5-year outcomes and influence of age and comorbidity. J Rheumatol. 2007 Feb;34(2):394-400. Epub 2006 Nov 15.
PubMed 17143967Hossain M, Parfitt DJ, Beard DJ, Darrah C, Nolan J, Murray DW, Andrew G. Does pre-operative psychological distress affect patient satisfaction after primary total hip arthroplasty? BMC Musculoskelet Disord. 2011 Jun 1;12:122. doi: 10.1186/1471-2474-12-122.
PubMed 21631923Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222.
PubMed 21978244Nilsdotter AK, Isaksson F. Patient relevant outcome 7 years after total hip replacement for OA - a prospective study. BMC Musculoskelet Disord. 2010 Mar 11;11:47. doi: 10.1186/1471-2474-11-47.
PubMed 20222962Mayr E, Nogler M, Benedetti MG, Kessler O, Reinthaler A, Krismer M, Leardini A. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech (Bristol). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21.
PubMed 19699566Stief F, Schmidt A, van Drongelen S, Lenarz K, Froemel D, Tarhan T, Lutz F, Meurer A. Abnormal loading of the hip and knee joints in unilateral hip osteoarthritis persists two years after total hip replacement. J Orthop Res. 2018 Mar 14. doi: 10.1002/jor.23886. Online ahead of print.
PubMed 29536559Bahl JS, Nelson MJ, Taylor M, Solomon LB, Arnold JB, Thewlis D. Biomechanical changes and recovery of gait function after total hip arthroplasty for osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2018 Jul;26(7):847-863. doi: 10.1016/j.joca.2018.02.897. Epub 2018 Feb 21.
PubMed 29474993Kolk S, Minten MJ, van Bon GE, Rijnen WH, Geurts AC, Verdonschot N, Weerdesteyn V. Gait and gait-related activities of daily living after total hip arthroplasty: a systematic review. Clin Biomech (Bristol). 2014 Jun;29(6):705-18. doi: 10.1016/j.clinbiomech.2014.05.008. Epub 2014 Jun 2.
PubMed 24951319Bennett D, Ryan P, O'Brien S, Beverland DE. Gait kinetics of total hip replacement patients-A large scale, long-term follow-up study. Gait Posture. 2017 Mar;53:173-178. doi: 10.1016/j.gaitpost.2017.01.014. Epub 2017 Jan 21.
PubMed 28171843Agostini V, Ganio D, Facchin K, Cane L, Moreira Carneiro S, Knaflitz M. Gait parameters and muscle activation patterns at 3, 6 and 12 months after total hip arthroplasty. J Arthroplasty. 2014 Jun;29(6):1265-72. doi: 10.1016/j.arth.2013.12.018. Epub 2013 Dec 18.
PubMed 24439753Longworth JA, Chlosta S, Foucher KC. Inter-joint coordination of kinematics and kinetics before and after total hip arthroplasty compared to asymptomatic subjects. J Biomech. 2018 Apr 27;72:180-186. doi: 10.1016/j.jbiomech.2018.03.015. Epub 2018 Mar 16.
PubMed 29576311Beaulieu ML, Lamontagne M, Beaule PE. Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture. 2010 Jun;32(2):269-73. doi: 10.1016/j.gaitpost.2010.05.007. Epub 2010 Jun 11.
PubMed 20541940Lamontagne M, Beaulieu ML, Varin D, Beaule PE. Lower-limb joint mechanics after total hip arthroplasty during sitting and standing tasks. J Orthop Res. 2012 Oct;30(10):1611-7. doi: 10.1002/jor.22127. Epub 2012 Apr 16.
PubMed 22508467Palan J, Manktelow A. Surgical approaches for primary total hip replacement. Orthopaedics and Trauma. 2018;32(1):1-12.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Biomechanical Analysis in Immediate Post-Operative Period Following Total Hip Arthroplasty - A Pilot Study
- ClinicalTrials.gov ID
- NCT04928924
- Acronym / sponsor ID
- 19-07
- Conditions
- Arthritis of Hip
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, biomechanical assessment, gait analysis, movement analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- Stryker GI Ltd.
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Jun 2021 (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.
The objective of this study is to investigate the feasibility of functional 3D biomechanical assessment and EMG analysis of gait and a sit to stand tasks in the immediate post-operative phase following total hip arthroplasty.
Detailed description
Functional recovery is often an important priority for patients undergoing total hip arthroplasty (THA) and it is thought that abnormal biomechanics may be an obstacle to full recovery of physical function. While there has been extensive research on the biomechanics of gait and other activities of daily living following THA, the earliest reported post-operative assessment of function using 3D motion analysis for kinematics and kinetics has been at 6 weeks post-surgery. There is a paucity of data from the immediate post-operative phase prior to patient discharge from hospital.
In recent years there has been an increase in initiatives such as fast-track or enhanced post-operative recovery programs following joint arthroplasty, with the aim being an early return to function and shorter hospital length of stay whilst maintaining the low morbidity and mortality and high satisfaction rates typically associated with THA. There has also been continued research and developments on improving the THA procedure and while initial focus on improving THA surgery centred on implant design, materials and fixation to bone, there has been increased attention to surgical approach. In the last 10 years the use of minimally invasive surgical techniques has become more widespread due to the potential reported benefits. These include a shorter incision length, reduced muscle damage, reduced pain and less bleeding. When combined, these benefits may lead to reduced length of hospital stay and earlier return to function.
With so much focus centred on early return to function, there is a need to objectively measure function in the immediate post-operative phase. This would allow us to evaluate the effect of minimally invasive surgical approaches and enhanced recovery programs, which are primarily centred on early recovery from surgery. The use of 3D motion capture technology allows for accurate assessment of joint movement in three planes during dynamic movements and has been used extensively in the evaluation of function in patients with significant hip pathology before and after total hip arthroplasty. As aforementioned, to date the earliest post-operative motion analysis has been at 6 weeks after THA. Similarly, the earliest reported time point for muscle activation analysis using EMG is 6 weeks post THA. The aim of this study is assess the feasibility of 3D motion analysis including EMG in the immediate post-operative phase following THA in a hospital which incorporates an Enhanced Recovery After Surgery (ERAS) program as part of routine clinical care. This pilot project will guide development of future protocols which require early post-operative 3D biomechanical analysis.
For the purposes of this study the investigators define the immediate post-operative time point as the day the patient is discharged from the inpatient rehabilitation team and therefore deemed "safe" to mobilise independently by the ward physiotherapists.
Subject recruitment and retention will be closely monitored throughout the trial, allowing us to measure recruitment and dropout rates. Where possible, reasons for declining participation in the study and reasons for dropout will be documented. The ability of the patients to perform study related assessments will be recorded in addition to the reason for them being unable to perform the task, this will be done via a questionnaire that patients will complete at the end of each 3D biomechanical assessment session.
Patients will be asked to attend a biomechanical testing session before their surgery. After surgery they will follow standard aftercare, and on the day of discharge from the inpatient physiotherapy team they will be asked to attend the second biomechanical testing session. The third and fourth sessions will be on day three and day seven post-surgery, and the final session will take place when they return to the hospital for their standard three month follow up with the arthroplasty team. At the end of the three month visit, their involvement in the study will be complete.
Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers and surface electrodes will be attached to specific locations on the body using suitable double sided tape which can be tracked by a number of infrared cameras. participants will be asked to perform the following tasks; walking, sit-to-stand and stand-to-sit. Each task will be performed at least three times to enable the collection of three good sets of data. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred to the Golden Jubilee National Hospital for total hip replacement.
Key inclusion criteria (3 listed)
- Patients suitable for posterolateral approach total hip arthroplasty
- Able to give informed consentAble to return to study site for follow-up
- BMI under 35
Key exclusion criteria (5 listed)
- Previous hip procedure in the previous twelve months
- Previous knee surgery other than arthroscopy and medial menisectomy in the last twelve months
- Symptomatic foot, knee, contralateral hip or spinal pathology
- Any medical condition limiting normal ambulation e.g. stroke, Parkinsons disease, severe lymphedema, advanced cardiac disease
- Unable to read and understand English and follow verbal and visual instructions unless they can bring a relative or friend to all study assessments to act as a translator
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 |
|---|---|---|
| Total Hip ArthroplastyWe will be observing patients who have undergone surgical replacement of arthritic hip with an implant. | Procedure or surgery | – |
Primary outcome
Patient adherence to study procedures
Time frame: 3 months
Patients ability to attend for follow up appointments and carry out study specific biomechanical assessments
9 secondary outcomes
Eligible patients
Time frame: 1 year
Recruitment rate
Time frame: 1 year
Loss to follow up
Time frame: 3 months
Hip angles during walking
Time frame: 3 months
Hip loads during walking
Time frame: 3 months
Hip angles during sit to stand to sit
Time frame: 3 months
Hip loads during sit to stand to sit
Time frame: 3 months
Muscle activation patterns walking
Time frame: 3 months
Muscle activation patterns stand to sit to stand
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 29783896Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21.
- Background: PubMed 17143967Lubbeke A, Katz JN, Perneger TV, Hoffmeyer P. Primary and revision hip arthroplasty: 5-year outcomes and influence of age and comorbidity. J Rheumatol. 2007 Feb;34(2):394-400. Epub 2006 Nov 15.
- Background: PubMed 21631923Hossain M, Parfitt DJ, Beard DJ, Darrah C, Nolan J, Murray DW, Andrew G. Does pre-operative psychological distress affect patient satisfaction after primary total hip arthroplasty? BMC Musculoskelet Disord. 2011 Jun 1;12:122. doi: 10.1186/1471-2474-12-122.
- Background: PubMed 21978244Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222.
- Background: PubMed 20222962Nilsdotter AK, Isaksson F. Patient relevant outcome 7 years after total hip replacement for OA - a prospective study. BMC Musculoskelet Disord. 2010 Mar 11;11:47. doi: 10.1186/1471-2474-11-47.
- Background: PubMed 19699566Mayr E, Nogler M, Benedetti MG, Kessler O, Reinthaler A, Krismer M, Leardini A. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech (Bristol). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21.
- Background: PubMed 29536559Stief F, Schmidt A, van Drongelen S, Lenarz K, Froemel D, Tarhan T, Lutz F, Meurer A. Abnormal loading of the hip and knee joints in unilateral hip osteoarthritis persists two years after total hip replacement. J Orthop Res. 2018 Mar 14. doi: 10.1002/jor.23886. Online ahead of print.
- Background: PubMed 29474993Bahl JS, Nelson MJ, Taylor M, Solomon LB, Arnold JB, Thewlis D. Biomechanical changes and recovery of gait function after total hip arthroplasty for osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2018 Jul;26(7):847-863. doi: 10.1016/j.joca.2018.02.897. Epub 2018 Feb 21.
- Background: PubMed 24951319Kolk S, Minten MJ, van Bon GE, Rijnen WH, Geurts AC, Verdonschot N, Weerdesteyn V. Gait and gait-related activities of daily living after total hip arthroplasty: a systematic review. Clin Biomech (Bristol). 2014 Jun;29(6):705-18. doi: 10.1016/j.clinbiomech.2014.05.008. Epub 2014 Jun 2.
- Background: PubMed 28171843Bennett D, Ryan P, O'Brien S, Beverland DE. Gait kinetics of total hip replacement patients-A large scale, long-term follow-up study. Gait Posture. 2017 Mar;53:173-178. doi: 10.1016/j.gaitpost.2017.01.014. Epub 2017 Jan 21.
- Background: PubMed 24439753Agostini V, Ganio D, Facchin K, Cane L, Moreira Carneiro S, Knaflitz M. Gait parameters and muscle activation patterns at 3, 6 and 12 months after total hip arthroplasty. J Arthroplasty. 2014 Jun;29(6):1265-72. doi: 10.1016/j.arth.2013.12.018. Epub 2013 Dec 18.
- Background: PubMed 29576311Longworth JA, Chlosta S, Foucher KC. Inter-joint coordination of kinematics and kinetics before and after total hip arthroplasty compared to asymptomatic subjects. J Biomech. 2018 Apr 27;72:180-186. doi: 10.1016/j.jbiomech.2018.03.015. Epub 2018 Mar 16.
- Individual participant dataSharing planned: No
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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.
Nicholas Ohly, MBBS, FRCSEd principal investigator
Golden Jubilee National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis of Hip, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
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?
Patient adherence to study procedures (time frame: 3 months). 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 NCT04928924, which also lists 19 linked publications.
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 16 Jun 2021.