Total Hip ReplacementsYOUNG HIPNCT04660149
An Exploration Into the Young Patients' (< 50 Years) Expectations Following Primary Total Hip Arthroplasty
An observational study of Total Hip Replacements, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
This study seeks to explore between 6-7 patient participants' (18-50 years old inclusive) own expectations and hopes leading up to a THA, then to examine their own views on their recovery and rehabilitation post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Total Hip Replacements
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2021to 27 Apr 2023
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients attending Milton Keynes University Hospital and scheduled to undergo a Primary Total hip replacement
Who may be able to join
- Patients 18-50 years of age inclusive.
- Scheduled to undergo a primary THR in the index hip in the next 12-18 months. (Patients will still be eligible despite previously having a THR in the opposing hip)
- Able to provide informed consent.
- Ability to understand and communicate in English.
Who cannot join
- Under 18 years of age
- Over 50 years of age
- Undergoing a revision of THR in the index hip.
- Unable to provide informed consent or participate in study interviews.
- Unable or unwilling to complete follow up interviews.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Milton Keynes University Hospital
Milton Keynes, MK6 5LD
About this study
Official title: An Exploration Into the Young Patients' (< 50 Years) Expectations Following Primary Total Hip Arthroplasty: What Outcomes Are Important to Them? A Qualitative Study.
This study seeks to explore between 6-7 patient participants' (18-50 years old inclusive) own expectations and hopes leading up to a THA, then to examine their own views on their recovery and rehabilitation post-operatively. A qualitative, longitudinal approach will be utilised for this research with a generic qualitative method analysing the verbal data taken during interviews with participants. A combination of semi-structured and narrative interview techniques will investigate the patients' individual expected outcomes and priorities for their recovery.
The study approach seeks to explore the patients' own views of a successful outcome of THA, it hopes to discover any potential themes of needs and priorities in the younger patient, and compare these to the standard way of measuring these outcomes by using PROMS. The outcome will contribute to determining what more can be done to improve the care currently in place for this increasing group of patients.
Read the detailed description
To be confident that healthcare providers are providing the very best patient care in the instance of the younger patient it is essential to ask them their own interpretation of needs and priorities, and how they feel they can be met. There currently is an urgent need for further studies into the area of total hip arthroplasty in young patients, especially qualitative research defining the outcomes important to them after surgery. The considerably larger, older patient population undergoing this surgery often influence the way post-operative outcomes are measured (Larsson et al 2019, Mannion et al 2009, Wright and Young 1997, Wright et al 2000).
The study aims to discover and explore the following questions:
Are the priorities of the younger patient (< 50) being addressed and fulfilled when undergoing a THR? Are the current Outcome Measures identifying the priorities and required outcomes of the younger patient (< 50) undergoing a THR? The study will use a qualitative approach and method. Interviews will be conducted either face to face, via telephone or video calls dependent on participant preference. Semi-structured and narrative methods will be combined to encourage the participant to talk freely in regard to their own views and opinions on their surgery. Participants will also be asked to complete the Hip Disability and Osteoarthritis Hip Score (HOOS) at baseline (pre surgery), 6 weeks post-surgery and 6 months post-surgery time points to examine if this outcome measure illustrates a similar state to that which they described during their interviews.
With the participants' consent, these interviews will be recorded and transcribed by the Chief Investigator.
Participants will be assigned a study number on recruitment. All data will be anonymised and labelled with the appropriate participant's study number.
Audio recordings of qualitative interviews will be transcribed by the Chief Investigator and anonymised transcriptions will be stored on secure servers at Milton Keynes University Hospital (MKUH). The audio recordings will be deleted at the end of the study.
Consent forms, any paper case report forms (CRF) and completed HOOS will be filed in the site file which will be held in a secure, locked filing cabinet within the Research and Development Department at Milton Keynes University Hospital. Identifiable data will be kept separately from the outcome data (both paper and electronic).
No identifiable information will be shared with other persons at any point. The study plans to interview the participants at three different time points in their surgical journey. The first will be pre surgery (baseline) at around the time that the operative treatment is decided upon and the Surgeon has listed them for surgery. The second interview will be conducted around six weeks post operatively (+ 14 days), this will explore the patients' thoughts on their immediate post-operative recovery and how they feel they are progressing. The final time will be six months post-surgery (+ 30 days); this interview will examine the patients' own opinions on their surgical outcomes and their own interpretation of the success of the procedure. The HOOS will also be completed at each time point.
- Conditions
- Total Hip Replacements
What is being measured
The primary outcome is the main question the study is designed to answer.
Are the priorities of the younger patient (< 50) being addressed and fulfilled when undergoing a THR?
The priorities and goals of the participant will be explored through the study interviews, these findings will be compared with the outcomes recorded when caring for these patients.
Measured: 12-18 months
Are the current Outcome Measures identifying the priorities and required outcomes of the younger patient (< 50) undergoing a THR?
The data recorded in the interview will be compared with the Patient Reported Outcome Measures reported at the same time, to compare the two findings.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start11 Apr 2021
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementsStudies 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
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Mew, Study director, Research Nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660149
- Sponsor's protocol ID
- 2021/IRAS/LM
- Acronym
- YOUNG HIP
- Status last verified
- Jul 2023
- First submitted
- 2 Dec 2020
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable patient information is to be shared with any other researcher
Publications
Larsson A, Rolfson O, Karrholm J. Evaluation of Forgotten Joint Score in total hip arthroplasty with Oxford Hip Score as reference standard. Acta Orthop. 2019 Jun;90(3):253-257. doi: 10.1080/17453674.2019.1599252. Epub 2019 Apr 1.
PubMed 30931686Mannion AF, Kampfen S, Munzinger U, Kramers-de Quervain I. The role of patient expectations in predicting outcome after total knee arthroplasty. Arthritis Res Ther. 2009;11(5):R139. doi: 10.1186/ar2811. Epub 2009 Sep 21.
PubMed 19772556Wright JG, Young NL. The patient-specific index: asking patients what they want. J Bone Joint Surg Am. 1997 Jul;79(7):974-83. doi: 10.2106/00004623-199707000-00003.
PubMed 9234873Wright JG, Young NL, Waddell JP. The reliability and validity of the self-reported patient-specific index for total hip arthroplasty. J Bone Joint Surg Am. 2000 Jun;82(6):829-37. doi: 10.2106/00004623-200006000-00009.
PubMed 10859102
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration Into the Young Patients' (< 50 Years) Expectations Following Primary Total Hip Arthroplasty: What Outcomes Are Important to Them? A Qualitative Study.
- ClinicalTrials.gov ID
- NCT04660149
- Acronym / sponsor ID
- YOUNG HIP / 2021/IRAS/LM
- Conditions
- Total Hip Replacements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 9 Dec 2020 (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.
This study seeks to explore between 6-7 patient participants' (18-50 years old inclusive) own expectations and hopes leading up to a THA, then to examine their own views on their recovery and rehabilitation post-operatively. A qualitative, longitudinal approach will be utilised for this research with a generic qualitative method analysing the verbal data taken during interviews with participants. A combination of semi-structured and narrative interview techniques will investigate the patients' individual expected outcomes and priorities for their recovery.
The study approach seeks to explore the patients' own views of a successful outcome of THA, it hopes to discover any potential themes of needs and priorities in the younger patient, and compare these to the standard way of measuring these outcomes by using PROMS. The outcome will contribute to determining what more can be done to improve the care currently in place for this increasing group of patients.
Detailed description
To be confident that healthcare providers are providing the very best patient care in the instance of the younger patient it is essential to ask them their own interpretation of needs and priorities, and how they feel they can be met. There currently is an urgent need for further studies into the area of total hip arthroplasty in young patients, especially qualitative research defining the outcomes important to them after surgery. The considerably larger, older patient population undergoing this surgery often influence the way post-operative outcomes are measured (Larsson et al 2019, Mannion et al 2009, Wright and Young 1997, Wright et al 2000).
The study aims to discover and explore the following questions:
Are the priorities of the younger patient (< 50) being addressed and fulfilled when undergoing a THR? Are the current Outcome Measures identifying the priorities and required outcomes of the younger patient (< 50) undergoing a THR? The study will use a qualitative approach and method. Interviews will be conducted either face to face, via telephone or video calls dependent on participant preference. Semi-structured and narrative methods will be combined to encourage the participant to talk freely in regard to their own views and opinions on their surgery. Participants will also be asked to complete the Hip Disability and Osteoarthritis Hip Score (HOOS) at baseline (pre surgery), 6 weeks post-surgery and 6 months post-surgery time points to examine if this outcome measure illustrates a similar state to that which they described during their interviews.
With the participants' consent, these interviews will be recorded and transcribed by the Chief Investigator.
Participants will be assigned a study number on recruitment. All data will be anonymised and labelled with the appropriate participant's study number.
Audio recordings of qualitative interviews will be transcribed by the Chief Investigator and anonymised transcriptions will be stored on secure servers at Milton Keynes University Hospital (MKUH). The audio recordings will be deleted at the end of the study.
Consent forms, any paper case report forms (CRF) and completed HOOS will be filed in the site file which will be held in a secure, locked filing cabinet within the Research and Development Department at Milton Keynes University Hospital. Identifiable data will be kept separately from the outcome data (both paper and electronic).
No identifiable information will be shared with other persons at any point. The study plans to interview the participants at three different time points in their surgical journey. The first will be pre surgery (baseline) at around the time that the operative treatment is decided upon and the Surgeon has listed them for surgery. The second interview will be conducted around six weeks post operatively (+ 14 days), this will explore the patients' thoughts on their immediate post-operative recovery and how they feel they are progressing. The final time will be six months post-surgery (+ 30 days); this interview will examine the patients' own opinions on their surgical outcomes and their own interpretation of the success of the procedure. The HOOS will also be completed at each time point.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients attending Milton Keynes University Hospital and scheduled to undergo a Primary Total hip replacement
Key inclusion criteria (4 listed)
- Patients 18-50 years of age inclusive.
- Scheduled to undergo a primary THR in the index hip in the next 12-18 months. (Patients will still be eligible despite previously having a THR in the opposing hip)
- Able to provide informed consent.
- Ability to understand and communicate in English.
Key exclusion criteria (5 listed)
- Under 18 years of age
- Over 50 years of age
- Undergoing a revision of THR in the index hip.
- Unable to provide informed consent or participate in study interviews.
- Unable or unwilling to complete follow up interviews.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Are the priorities of the younger patient (< 50) being addressed and fulfilled when undergoing a THR?
Time frame: 12-18 months
The priorities and goals of the participant will be explored through the study interviews, these findings will be compared with the outcomes recorded when caring for these patients.
Are the current Outcome Measures identifying the priorities and required outcomes of the younger patient (< 50) undergoing a THR?
Time frame: 12-18 months
The data recorded in the interview will be compared with the Patient Reported Outcome Measures reported at the same time, to compare the two findings.
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 18 Jul 2023.
- Background: PubMed 30931686Larsson A, Rolfson O, Karrholm J. Evaluation of Forgotten Joint Score in total hip arthroplasty with Oxford Hip Score as reference standard. Acta Orthop. 2019 Jun;90(3):253-257. doi: 10.1080/17453674.2019.1599252. Epub 2019 Apr 1.
- Background: PubMed 19772556Mannion AF, Kampfen S, Munzinger U, Kramers-de Quervain I. The role of patient expectations in predicting outcome after total knee arthroplasty. Arthritis Res Ther. 2009;11(5):R139. doi: 10.1186/ar2811. Epub 2009 Sep 21.
- Background: PubMed 9234873Wright JG, Young NL. The patient-specific index: asking patients what they want. J Bone Joint Surg Am. 1997 Jul;79(7):974-83. doi: 10.2106/00004623-199707000-00003.
- Background: PubMed 10859102Wright JG, Young NL, Waddell JP. The reliability and validity of the self-reported patient-specific index for total hip arthroplasty. J Bone Joint Surg Am. 2000 Jun;82(6):829-37. doi: 10.2106/00004623-200006000-00009.
- Individual participant dataSharing planned: No. No identifiable patient information is to be shared with any other researcher
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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.
Louise Mew study director
Research Nurse
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 Total Hip Replacements, run by Bournemouth University 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 4 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: finished, as of the sponsor's last update on 18 Jul 2023. 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?
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?
Are the priorities of the younger patient (< 50) being addressed and fulfilled when undergoing a THR? (time frame: 12-18 months). The study lists 2 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 NCT04660149, which also lists 4 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 18 Jul 2023.