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

NCT04660149 | Completed

• 1 other identifier: 2021/IRAS/LM
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacements

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12-18 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients attending Milton Keynes University Hospital and scheduled to undergo a Primary Total hip replacement

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bournemouth University: lead

Study Sites (1)

Milton Keynes University Hospital

Milton Keynes, MK6 5LD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 30931686 BACKGROUND

• 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.

  PMID: 19772556 BACKGROUND

• 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.

  PMID: 9234873 BACKGROUND

• 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.

  PMID: 10859102 BACKGROUND

Study Officials

• Louise Mew

  Research Nurse

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: April 11, 2021
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)