An Exploration Into the Young Patients' (< 50 Years) Expectations Following Primary Total Hip Arthroplasty
NCT ID: NCT04660149
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2021-04-11
2023-04-27
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Bournemouth University
OTHER
Responsible Party
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Principal Investigators
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Louise Mew
Role: STUDY_DIRECTOR
Research Nurse
Locations
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Milton Keynes University Hospital
Milton Keynes, , United Kingdom
Countries
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References
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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.
Mannion 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.
Wright 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.
Wright 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.
Other Identifiers
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2021/IRAS/LM
Identifier Type: -
Identifier Source: org_study_id
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