Hip OsteoarthritisNCT05960903
Patient Satisfaction After Primary THA In Assiut University
An observational study of Hip Osteoarthritis, run by Assiut University.
Trial summary
measure the level of patient satisfaction after THA at the arthroplasty unit of Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Osteoarthritis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 May 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A dedicated sheet will be used to record patients' data . We conduct retrospective study.All patients followed and evaluated in our outpatient clinic at 3 month post-operatively. The questionnaire :(1) general satisfaction level after THA.(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. The Harris Hip Scale (HHS) and Oxford Hip Score were developed for the assessment of the results of hip surgery such as THA
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Patient Satisfaction After Primary Total Hip Arthroplasty In Assiut University Hospitals
measure the level of patient satisfaction after THA at the arthroplasty unit of Assiut University Hospital.
Read the 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
- Conditions
- Hip Osteoarthritis
- Medical subject headings
- Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction after Primary THA In Assiut University Hospitals
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
Measured: Baseline
measuring the level of satisfaction in primary cases of total hip arhroplasty
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
Measured: Baseline
Secondary outcomes (1)
Percentage of improvement and clinical and functional outcome after total hip Arthroplasty
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamza Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960903
- Sponsor's protocol ID
- Satisfaction in (THA)
- Status last verified
- Jul 2023
- First submitted
- 18 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okafor L, Chen AF. Patient satisfaction and total hip arthroplasty: a review. Arthroplasty. 2019 Sep 2;1(1):6. doi: 10.1186/s42836-019-0007-3.
PubMed 35240763Mancuso CA, Jout J, Salvati EA, Sculco TP. Fulfillment of patients' expectations for total hip arthroplasty. J Bone Joint Surg Am. 2009 Sep;91(9):2073-8. doi: 10.2106/JBJS.H.01802.
PubMed 19723982
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction After Primary Total Hip Arthroplasty In Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05960903
- Acronym / sponsor ID
- Satisfaction in (THA)
- Conditions
- Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 27 Jul 2023 (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.
measure the level of patient satisfaction after THA at the arthroplasty unit of Assiut University Hospital.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A dedicated sheet will be used to record patients' data . We conduct retrospective study.All patients followed and evaluated in our outpatient clinic at 3 month post-operatively. The questionnaire :(1) general satisfaction level after THA.(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. The Harris Hip Scale (HHS) and Oxford Hip Score were developed for the assessment of the results of hip surgery such as THA
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
Patient satisfaction after Primary THA In Assiut University Hospitals
Time frame: 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
measuring the level of satisfaction in primary cases of total hip arhroplasty
Time frame: 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
1 secondary outcome
Percentage of improvement and clinical and functional outcome after total hip Arthroplasty
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 35240763Okafor L, Chen AF. Patient satisfaction and total hip arthroplasty: a review. Arthroplasty. 2019 Sep 2;1(1):6. doi: 10.1186/s42836-019-0007-3.
- Background: PubMed 19723982Mancuso CA, Jout J, Salvati EA, Sculco TP. Fulfillment of patients' expectations for total hip arthroplasty. J Bone Joint Surg Am. 2009 Sep;91(9):2073-8. doi: 10.2106/JBJS.H.01802.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by Assiut University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Patient satisfaction after Primary THA In Assiut University Hospitals (time frame: Baseline). 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 NCT05960903, which also lists 2 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 27 Jul 2023.