Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02998125
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2016-12-14
Brief Title:
An Exploration of Outcomes Post-total Knee Arthroplasty in Middle East
Sponsor:
University of Salford
Organization:
University of Salford
Study Overview
Official Title:
A Psychometric Analysis of the Arabic Version of Oxford Knee Score Before and After Total Knee Arthroplasty in a Middle East Population and an Exploration of Outcomes Post-total Knee Arthroplasty in the Middle East
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intention is to explore whether there are factors which can help us to understand why some patient outcomes following total knee arthroplasty are not successful and identify prediction factors for progression Assessment of outcomes pre- and post-surgery with objective tools is a way to explore prediction tools for goodpoor progression and improve patient selection and timing for surgery
The first aim of this project is determine the psychometric properties of the Arabic Version of Oxford Knee Score including internal consistency reliability and validity before and post-total knee arthroplasty in both males and females in a Middle East population The second aim is to assess the reliability of the Star Excursion Balance Test for measuring the dynamic balance The final aim is explore outcomes post-total knee arthroplasty among Middle East patients using the Arabic Version of Oxford Knee Score physical activity measures and performance-based measurements such as 30 s chair-stand test stair-climb test timed up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society International recommendations
The first aim of this project is determine the psychometric properties of the Arabic Version of Oxford Knee Score including internal consistency reliability and validity before and post-total knee arthroplasty in both males and females in a Middle East population The second aim is to assess the reliability of the Star Excursion Balance Test for measuring the dynamic balance The final aim is explore outcomes post-total knee arthroplasty among Middle East patients using the Arabic Version of Oxford Knee Score physical activity measures and performance-based measurements such as 30 s chair-stand test stair-climb test timed up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society International recommendations
Detailed Description:
Project objectives
To gain an understanding of recovery post-TKA in a Saudi population and explore whether there are factors which can help us to understand why some patient outcomes are not successful and identify prediction factors for progression It is a prospective study measuring outcomes six months post-TKA with the following objectives
Examine the internal consistency reliability and validity of the Arabic Version of Oxford Knee Score before and after total knee arthroplasty in both male and female Middle East patients
Examine the test- re-test reliability of the Star Excursion Balance Test in both male and female Middle Eastern patients
Measure patient outcomes post-total knee arthroplasty using patient self-reporting activity measurements and the Arabic Version of Oxford Knee Score
Evaluate physical activity level improvements post-knee arthroplasty using objective methods and an accelerometer ActivPAL
Assess functional recovery post-knee arthroplasty according to Osteoarthritis Research Society International recommendations using performance-based measurements such as 30 s chair-stand test stair-climb test timed up-and-go test and a 6 m walk test alongside functional balance
The rationale which led to this project
Knee osteoarthritis OA is a major cause of disability around the world it is the most common chronic condition in primary care in the UK By 2030 it is predicted to be the greatest cause of disability in the general population An effective end-stage treatment for knee OA is knee-replacement surgery which was first done in the 1970s and 1980s
In England and Wales the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91703 which represents an increase of 09 over 2012 The data analysis by the National Joint Registry and the Office of National Statistics suggests that by 2030 primary TKAs will increase by 117 from the 2012 level Subsequently TKA revision surgeries are expected to increase incrementally by 332 There is a similar estimation of demand for revision TKA surgeries in the United States by 2030 they are expected to rise by 601 from the 2005 level The United States estimation of primary TKA is for growth of 673 from the 2005 level which is similar to England and Waless upper-limit projections
Post-TKA 75-85 of patients report satisfaction with surgery outcomes while the remaining 15-25 are dissatisfied Klit Jacobsen Rosenlund Sonne-Holm Troelsen 2014 Total knee arthroplastys success has traditionally been evaluated from the surgeons perspective eg the presence of surgical complications or implant survival This is gradually changing to involve the patient in measuring health outcomes and decision-making processes Patient-reported outcome measures PROMs have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes
PROM results cannot exclude the Research Participant Effect RPE or subjective overunderestimation due to psychosocial effects or pain from other joints such as hips or back Hence objective clinical evaluation methods can minimize patients subjective overunderestimations of outcomes though RPE can not be excluded Objective assessment has some advantages over PROMs such as a lack of ceiling effects and more precision and responsiveness and it does not require cultural and language adaptation Performance-based Outcome Measures PBOMs have the advantage of being objective measures that do not overlap with pain measurement They are sensitive to detecting change responsive have a minimal ceiling effect and are feasible
PROMs and PBOM measurement tools assess different aspects of function post-TKA PROMs mainly assess patients functional ability beliefs and experiences while objective functional assessment instruments and PBOM measurement tools evaluate patients actual ability and function Therefore to conduct comprehensive functional assessments post-TKA PROMs objective functional assessment instruments and PBM measurement tools are recommended
To the best of our knowledge no study has explored the outcome post TKA using the PROMs PBOMs and functional balance measurement tools in Saudi male and female population or explored possible accurate prediction factors for outcomes post-TKA Reliable outcome prediction could however improve patient selection for surgery as appropriate timing for surgery depends on patient symptoms and efficient patient preparation for surgery if it is to be cost-effective Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations about outcomes
This study will investigate outcomes post-total knee arthroplasty and factors that may predict goodpoor progression using three categories of outcome measurements in order to minimize subjective over underestimation of surgical outcomes Thus the study seeks to explore accurate and objective prediction factors of post-total knee arthroplasty progression
Potentially reliable outcome predictions could improve patient selection for surgery as appropriate timing for surgery depends on patients symptoms and efficient patient preparation for surgery if it is to be cost-effective Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations about outcomes
To gain an understanding of recovery post-TKA in a Saudi population and explore whether there are factors which can help us to understand why some patient outcomes are not successful and identify prediction factors for progression It is a prospective study measuring outcomes six months post-TKA with the following objectives
Examine the internal consistency reliability and validity of the Arabic Version of Oxford Knee Score before and after total knee arthroplasty in both male and female Middle East patients
Examine the test- re-test reliability of the Star Excursion Balance Test in both male and female Middle Eastern patients
Measure patient outcomes post-total knee arthroplasty using patient self-reporting activity measurements and the Arabic Version of Oxford Knee Score
Evaluate physical activity level improvements post-knee arthroplasty using objective methods and an accelerometer ActivPAL
Assess functional recovery post-knee arthroplasty according to Osteoarthritis Research Society International recommendations using performance-based measurements such as 30 s chair-stand test stair-climb test timed up-and-go test and a 6 m walk test alongside functional balance
The rationale which led to this project
Knee osteoarthritis OA is a major cause of disability around the world it is the most common chronic condition in primary care in the UK By 2030 it is predicted to be the greatest cause of disability in the general population An effective end-stage treatment for knee OA is knee-replacement surgery which was first done in the 1970s and 1980s
In England and Wales the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91703 which represents an increase of 09 over 2012 The data analysis by the National Joint Registry and the Office of National Statistics suggests that by 2030 primary TKAs will increase by 117 from the 2012 level Subsequently TKA revision surgeries are expected to increase incrementally by 332 There is a similar estimation of demand for revision TKA surgeries in the United States by 2030 they are expected to rise by 601 from the 2005 level The United States estimation of primary TKA is for growth of 673 from the 2005 level which is similar to England and Waless upper-limit projections
Post-TKA 75-85 of patients report satisfaction with surgery outcomes while the remaining 15-25 are dissatisfied Klit Jacobsen Rosenlund Sonne-Holm Troelsen 2014 Total knee arthroplastys success has traditionally been evaluated from the surgeons perspective eg the presence of surgical complications or implant survival This is gradually changing to involve the patient in measuring health outcomes and decision-making processes Patient-reported outcome measures PROMs have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes
PROM results cannot exclude the Research Participant Effect RPE or subjective overunderestimation due to psychosocial effects or pain from other joints such as hips or back Hence objective clinical evaluation methods can minimize patients subjective overunderestimations of outcomes though RPE can not be excluded Objective assessment has some advantages over PROMs such as a lack of ceiling effects and more precision and responsiveness and it does not require cultural and language adaptation Performance-based Outcome Measures PBOMs have the advantage of being objective measures that do not overlap with pain measurement They are sensitive to detecting change responsive have a minimal ceiling effect and are feasible
PROMs and PBOM measurement tools assess different aspects of function post-TKA PROMs mainly assess patients functional ability beliefs and experiences while objective functional assessment instruments and PBOM measurement tools evaluate patients actual ability and function Therefore to conduct comprehensive functional assessments post-TKA PROMs objective functional assessment instruments and PBM measurement tools are recommended
To the best of our knowledge no study has explored the outcome post TKA using the PROMs PBOMs and functional balance measurement tools in Saudi male and female population or explored possible accurate prediction factors for outcomes post-TKA Reliable outcome prediction could however improve patient selection for surgery as appropriate timing for surgery depends on patient symptoms and efficient patient preparation for surgery if it is to be cost-effective Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations about outcomes
This study will investigate outcomes post-total knee arthroplasty and factors that may predict goodpoor progression using three categories of outcome measurements in order to minimize subjective over underestimation of surgical outcomes Thus the study seeks to explore accurate and objective prediction factors of post-total knee arthroplasty progression
Potentially reliable outcome predictions could improve patient selection for surgery as appropriate timing for surgery depends on patients symptoms and efficient patient preparation for surgery if it is to be cost-effective Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations about outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None