Patient Satisfaction After Primary THA In Assiut University

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05960903
Collaborator
(none)
50
20

Study Details

Study Description

Brief Summary

measure the level of patient satisfaction after THA at the arthroplasty unit of Assiut University Hospital.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A dedicated sheet will be used to record patients' data including all demographic data, detailed analysis of time of injury, time and details of surgery . Investigators conduct retrospective study and review the case detalis for 50 eligible patients who underwent total hip arthroplasty between December 2021 and December 2022 in our Assiut University Orthopaedics and Trauma surgery Department All patients followed and evaluated in our outpatient clinic at 3 month post-operatively. In addition to clinical, neurological, and radiological examination, a dedicated and validated questionnaire will be used for measuring the clinical and functional outcome at each visit.

    The questionnaire includes three majors parts (1) general satisfaction level after total hip arthroplasty .(2) satisfaction level for 16 subordinate items : pain relief, walking on a flat surface , ascending stairs , getting in/out of cars, squatting, rising after squatting, putting on and tying shoes, walking fast or jogging, limp length discrepancy , hip squeaking( cases of ceramic and non ceramic implant) , hip stiffness, abnormal feeling in the hip, muscle weakness when walking, hip numbness and discomfort in cold weather(3) Ranking the top 5 important functions or issues among the 16 items , with "important" being defined as what patients are currently most concerned with.Objective The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery such as total hip arthroplasty , and we intended to use it in evaluation of patient satisfaction level There are ten items covering four domains. The domains are pain, function, absence of deformity, and range of motion The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain is divided into daily activities and gait. The deformity domains observes hip flexion, adduction, internal rotation, and extremity length discrepancy while the range of motion domain asses hip (ROM) .The Harris Hip Score (HHS) is divided into three sections. The first section are questions about pain and its impact which are answered by the patient or client. The second and third sections require the clinician The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following <70 = very dissatisfied result; 70-80 = somewhat dissatisfied , 80-90 = somewhat satisfied , and 90-100 = very satisfied .then a two category satisfaction outcome was determined for each question by combining patients who answered very dissatisfied , dissatisfied into " Dissatisfied group " and combining those who answered satisfied or very satisfied into " Satisfied group " . These two categories were used for all statical analysis

    The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip arthroplasty Its' primary goal during development was to assess pain and function in patients undergoing joint replacement surgery.

    The OHS is a short 12-item survey in which Patients are asked to reflect on their pain and functional ability over the previous 3 months There are two domains (pain and function) with six items or questions in each. Each item has four possible responses. In the scoring responses range from 0 to 4 where 0 represents the worst outcome and 4 represents the best. In this use, 48 is the maximum (and best) score achievable The scores for the 0-48 scale can be interpreted as follows Score 0 to 19 May indicate severe hip arthritis. Score 20 to 29 May indicate moderate to severe hip arthritis. Score 30 to 39 May indicate mild to moderate hip arthritis. Score 40 to 48 May indicate satisfactory joint function

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Patient Satisfaction After Primary Total Hip Arthroplasty In Assiut University Hospitals
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    May 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Patient satisfaction after Primary THA In Assiut University Hospitals [Baseline]

      Percentage of improvement and satisfaction following THA during the follow up visits by using The Harris Hip Score which used as a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible100 so results less than 80= dissatisfied group more than 80= satisfied group

    2. measuring the level of satisfaction in primary cases of total hip arhroplasty [Baseline]

      Percentage of improvement and level of satisfaction following THA by using Oxford Hip Score which used as a measure designed to assess disability in patients undergoing total hip arthroplasty. the maximum score is possible 48 so the higher results, the better outcome

    Secondary Outcome Measures

    1. Percentage of improvement and clinical and functional outcome after total hip Arthroplasty [Baseline]

      measuring the clinical and functional outcome at each visit by using The questionnaire that includes three majors parts (1) general satisfaction level after total hip arthroplasty .(2) satisfaction level for 16 subordinate items : pain relief, walking on a flat surface , ascending stairs , getting in/out of cars, squatting, rising after squatting, putting on and tying shoes, walking fast or jogging, (LLD) , hip squeaking( cases of ceramic and non ceramic implant) , hip stiffness, abnormal feeling in the hip, muscle weakness when walking, hip numbness and discomfort in cold weather(3) Ranking the top 5 important functions or issues among the 16 items , with "important" being defined as what patients are currently most concerned with

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • outpatients

    • A sufficient level of education to understand study procedures and be able to communicate with site personnel

    • 50 eligible cases from the patients who underwent THA between December 2021 and December 2022 in our Assiut University Orthopaedics and Trauma surgery Department

    • All ages of the patients

    • All types of THA

    Exclusion Criteria:
    • Post traumatic Patients who are not available for 3 months follow-up

    • Patients who refuse to participate in the study

    • Rheumatoid arthritis

    • All types of bone tumors

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Hamza Sayed Mohamed, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05960903
    Other Study ID Numbers:
    • Satisfaction in (THA)
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2023