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An Exploration Into the Young Patients' (< 50 Years) Expectations Following Primary Total Hip Arthroplasty (YOUNG HIP)

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ClinicalTrials.gov Identifier: NCT04660149
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Bournemouth University

Study Description
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Brief 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. 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.


Condition or disease
Total Hip Replacements

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
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Study Type : Observational
Estimated Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients attending Milton Keynes University Hospital and scheduled to undergo a Primary Total hip replacement
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660149


Contacts
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Contact: Julie Northam +441202961208 researchethics@bournemouth.ac.uk
Contact: Suzy Wignall +441202961073 researchethics@bournemouth.ac.uk

Locations
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United Kingdom
Milton Keynes University Hospital Recruiting
Milton keynes, United Kingdom, MK6 5LD
Contact: Louise Mew    01908995116    louise.mew@MKUH.NHS.UK   
Sponsors and Collaborators
Bournemouth University
Investigators
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Study Director: Louise Mew Research Nurse
More Information
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Publications:

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Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT04660149    
Other Study ID Numbers: 2021/IRAS/LM
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No identifiable patient information is to be shared with any other researcher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No