Total Knee ArthroplastyNCT02998125
An Exploration of Outcomes Post-total Knee Arthroplasty in Middle East
An observational study of Total Knee Arthroplasty, run by University of Salford at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2017to 18 Feb 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The present study is a prospective six and twelve month follow-up trial to explore the outcome post TKA in addition to assess the validity, reliability and responsiveness of the Arabic version of Oxford Knee Score and the Star Excursion Balance Test with total knee arthroplasty patients. An information sheet will be given to all participants who agree to participate to clarify the objectives of the study. Before participating, patients will need to sign a consent form (Appendix 2) and they will have the right to clarify any concerns about the study with the researcher. A patient's participation or otherwise will not affect the quality of service, all patients will receive conventional orthopedic care and a standard level of physiotherapy according to hospital protocols.
Who may be able to join
- All patients will be asked to participate during preadmission orthopedics clinic visits to King Khalid University Hospital in Riyadh if the patient;
- Scheduled for elective primary unilateral total knee arthroplasty.
- For end-stage knee osteoarthritis.
- In a stable and controlled medical condition,
Who cannot join
- Are scheduled for bilateral knee arthroplasty or unilateral knee revision surgery;
- Cannot read and understand Arabic
- Have limited function due to musculoskeletal conditions other than unilateral knee osteoarthritis.
- Have been diagnosed with uncontrolled diabetes mellitus or blood pressure.
- Have been diagnosed with any neurologic disorders, such as stroke, Parkinson's disease or multiple sclerosis.
- Are morbidly obese and have a body mass index (BMI) greater than 40.
Show all 9Show fewer
- Have advance osteoporosis or some other unstable chronic disease.
- Have been diagnosed with a peripheral vascular or uncontrolled cardiac disease.
- Participant will further be excluded post-surgery if they develop any surgical complications, such as deep vein thrombosis, uncontrolled infection or fracture.
Trial locations and contacts
1 site in 1 country.
About this study
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
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 good/poor 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.
Read the 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 91,703, which represents an increase of 0.9 % 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 Wales's 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 arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. 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 over/underestimation due to psychosocial effects or pain from other joints, such as hips or back. Hence, objective clinical evaluation methods can minimize patients' subjective over/underestimations 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 good/poor 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
prospective assessments for the functional outcome before and after the total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| before and after total knee arthroplasty | assess the functional outcome before and 6 months after total knee arthroplasty Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance based measurements change in Thirty second chair-stand test
A chair of 17 inches (45cm) height is used as the starting position for patients sitting with their arms cross the chest. Patients are instructed to stand and then sit with good buttock placement and back support, their hands on arm rests and feet correctly placed, then stand again as fast and safely as they can. The assessor counts the number of complete chair stands within 30 s. The mean of two trials will be used for analysis (Gill \& McBurney, 2008; Unver, Kalkan, Yuksel, Kahraman, \& Karatosun, 2015)
Measured: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
Performance based measurements change in Stair-climb test
Using a stopwatch accurate to 1/100 s, an assessor will measure the time required for a patient, using a handrail if required, to ascend and descend a flight of twelve steps 18 cm high and 28 cm deep. Patients will be instructed to ascend and descend the stairs as quickly, safely and comfortably as they can. The mean of two trials will be used for analysis (Mizner et al., 2011)
Measured: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
Performance based measurements change in Timed up-and-go test
The test procedure will use a stopwatch accurate to 1/100 s; a chair of standard 45 cm height, with armrests, will be placed on an outdoor level footpath and a line 3 metres from the chair will be drawn. Patients will be instructed to stand up from the chair, using the arms if required, walk for 3 metres to the line, then turn round and walk to sit back down on the chair as quickly, safely and comfortably as they can. An assessor will start timing as the patient leans forward to stand up, and stop when the patient's hips make contact with the seat to sit down. An average of two repetitions will be analysed (Ko, Naylor, Harris, Crosbie, \& Yeo, 2013; Mizner et al., 2011; Podsiadlo \& Richardson, 1991).
Measured: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
Performance based measurements change in Six minute walk test
The test will measure how far patients can walk in 6 minutes along a level 25-metre footpath. Patients can use an assistive device if required, take a rest if necessary and have standardized encouragement after each minute. The assessor will ask the patient to stop after 6 minutes. Only one test will be performed to avoid fatigue ("ATS Statement," 2002; Ko et al., 2013; Mizner et al., 2011).
Measured: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
Balance change
In the Star Excursion Balance Test, three tape measures will be fixed to the clinic floor, one oriented anteriorly to the apex and two aligned at 135° to the anterior tape in the posterolateral and posteromedial directions. (Fullam, Caulfield, Coughlan, \& Delahunt, 2014).
The patient will stand in the center of the grid and be instructed to stand on the affected or operated leg while reaching out as far as possible in one of the three directions with the other lower extremity, and then return that leg to the center. The participant will be asked to perform the test barefoot, keeping the heel of the stance leg on the floor at all times and to bend the knee of the stance leg. If the participant does not carry out any of these instructions, the trial will repeated.
The assessor will measure the reach distance in each direction in centimeters and then normalize the average of the three trials to leg length.
Measured: one week before admission day and 6 months after surgery to assess the balance changes post-surgery
Physical activity measurements change will be assess using an activPAL activity monitor (PAL Technologies, Glasgow, UK)
an activPAL activity monitor (PAL Technologies, Glasgow, UK) as this proven accelerometer provides objective quantification of free-living physical activity without any modification (Dahlgren, Carlsson, Moorhead, Hager-Ross, \& McDonough, 2010; Schmalzried et al., 1998). It is suitable as it light in weight (20g), includes an inclinometer and is small in size (53 x 35 x 7 mm) Figure 3. The device is worn by patient's mid-thigh, secured by non-allergic waterproof adhesive tape under their clothes, for 7-10 days before surgery and 6 months after. Clear written and verbal instructions will be given to patients as they have to wear it all day and all night except, when bathing or swimming (they can take a shower with it on).
Measured: one week before admission day and 6 months after surgery to assess the physical activity changes post-surgery
Secondary outcomes (2)
Arabic versions of Oxford Knee Score Validity assessment
The patients will be instructed to complete the Arabic versions of Oxford Knee Score, Arabic versions of Knee injury and Osteoarthritis Outcome Score (KOOS) and visual analogue scale (VAS) before Arthroplasty as baseline data in order to assess the correlation of Arabic versions of Oxford Knee Score with the Arabic version of KOOS and VAS to determine construct validity (Arabic versions of Oxford Knee Score, Knee injury and Osteoarthritis Outcome Score and visual analogue scale
Measured: one week before admission day
Arabic versions of Oxford Knee Score Reliability assessment
Patients will be asked to fill out Arabic forms independently without any interpretation to assess the Score reliability and responsiveness.
Measured: one week before admission day, admission day and 6 months after surgery and to evaluate the construct validity of the Arabic version of Oxford Knee Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion30 Dec 2018
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- King Khalid University Hospital, Princess Nourah Bint Abdulrahman University
- Responsible party
- Principal investigator, Bodor Bin sheeha, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998125
- Sponsor's protocol ID
- USalford-Bsheeha
- Status last verified
- May 2020
- First submitted
- 14 Dec 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.
PubMed 20710093Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.
PubMed 22539338Bullens PH, van Loon CJ, de Waal Malefijt MC, Laan RF, Veth RP. Patient satisfaction after total knee arthroplasty: a comparison between subjective and objective outcome assessments. J Arthroplasty. 2001 Sep;16(6):740-7. doi: 10.1054/arth.2001.23922.
PubMed 11547372Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
PubMed 22398175Charoencholvanich K, Pongcharoen B. Oxford knee score and SF-36: translation & reliability for use with total knee arthroscopy patients in Thailand. J Med Assoc Thai. 2005 Sep;88(9):1194-202.
PubMed 16536104Coughlan GF, Fullam K, Delahunt E, Gissane C, Caulfield BM. A comparison between performance on selected directions of the star excursion balance test and the Y balance test. J Athl Train. 2012 Jul-Aug;47(4):366-71. doi: 10.4085/1062-6050-47.4.03.
PubMed 22889651Dahlgren G, Carlsson D, Moorhead A, Hager-Ross C, McDonough SM. Test-retest reliability of step counts with the ActivPAL device in common daily activities. Gait Posture. 2010 Jul;32(3):386-90. doi: 10.1016/j.gaitpost.2010.06.022. Epub 2010 Jul 22.
PubMed 20655228Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PubMed 23680877Field, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.
Fullam K, Caulfield B, Coughlan GF, Delahunt E. Kinematic analysis of selected reach directions of the Star Excursion Balance Test compared with the Y-Balance Test. J Sport Rehabil. 2014 Feb;23(1):27-35. doi: 10.1123/jsr.2012-0114. Epub 2013 Aug 12.
PubMed 23945793Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141-52. doi: 10.1002/pri.411.
PubMed 18697226Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.
PubMed 22892416Harris K, Dawson J, Doll H, Field RE, Murray DW, Fitzpatrick R, Jenkinson C, Price AJ, Beard DJ. Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis. Qual Life Res. 2013 Nov;22(9):2561-8. doi: 10.1007/s11136-013-0393-x. Epub 2013 Mar 23.
PubMed 23526094Hertel J, Braham RA, Hale SA, Olmsted-Kramer LC. Simplifying the star excursion balance test: analyses of subjects with and without chronic ankle instability. J Orthop Sports Phys Ther. 2006 Mar;36(3):131-7. doi: 10.2519/jospt.2006.36.3.131.
PubMed 16596889
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02998125
- Acronym / sponsor ID
- USalford-Bsheeha
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- King Khalid University Hospital, Princess Nourah Bint Abdulrahman University
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
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 good/poor 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.
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 91,703, which represents an increase of 0.9 % 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 Wales's 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 arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. 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 over/underestimation due to psychosocial effects or pain from other joints, such as hips or back. Hence, objective clinical evaluation methods can minimize patients' subjective over/underestimations 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 good/poor 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before and after total knee arthroplasty | – | Procedure: Total knee arthroplastyassess the functional outcome before and 6 months after total knee arthroplasty |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study is a prospective six and twelve month follow-up trial to explore the outcome post TKA in addition to assess the validity, reliability and responsiveness of the Arabic version of Oxford Knee Score and the Star Excursion Balance Test with total knee arthroplasty patients. An information sheet will be given to all participants who agree to participate to clarify the objectives of the study. Before participating, patients will need to sign a consent form (Appendix 2) and they will have the right to clarify any concerns about the study with the researcher. A patient's participation or otherwise will not affect the quality of service, all patients will receive conventional orthopedic care and a standard level of physiotherapy according to hospital protocols.
Key inclusion criteria (4 listed)
- All patients will be asked to participate during preadmission orthopedics clinic visits to King Khalid University Hospital in Riyadh if the patient;
- Scheduled for elective primary unilateral total knee arthroplasty.
- For end-stage knee osteoarthritis.
- In a stable and controlled medical condition,
Key exclusion criteria (9 listed)
- Are scheduled for bilateral knee arthroplasty or unilateral knee revision surgery;
- Cannot read and understand Arabic
- Have limited function due to musculoskeletal conditions other than unilateral knee osteoarthritis.
- Have been diagnosed with uncontrolled diabetes mellitus or blood pressure.
- Have been diagnosed with any neurologic disorders, such as stroke, Parkinson's disease or multiple sclerosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyprospective assessments for the functional outcome before and after the total knee arthroplasty | Procedure or surgery | before and after total knee arthroplasty |
Primary outcome
Performance based measurements change in Thirty second chair-stand test
Time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
A chair of 17 inches (45cm) height is used as the starting position for patients sitting with their arms cross the chest. Patients are instructed to stand and then sit with good buttock placement and back support, their hands on arm rests and feet correctly placed, then stand again as fast and safely as they can. The assessor counts the number of complete chair stands within 30 s. The mean of two trials will be used for analysis (Gill \& McBurney, 2008; Unver, Kalkan, Yuksel, Kahraman, \& Karatosun, 2015)
Performance based measurements change in Stair-climb test
Time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
Using a stopwatch accurate to 1/100 s, an assessor will measure the time required for a patient, using a handrail if required, to ascend and descend a flight of twelve steps 18 cm high and 28 cm deep. Patients will be instructed to ascend and descend the stairs as quickly, safely and comfortably as they can. The mean of two trials will be used for analysis (Mizner et al., 2011)
Performance based measurements change in Timed up-and-go test
Time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
The test procedure will use a stopwatch accurate to 1/100 s; a chair of standard 45 cm height, with armrests, will be placed on an outdoor level footpath and a line 3 metres from the chair will be drawn. Patients will be instructed to stand up from the chair, using the arms if required, walk for 3 metres to the line, then turn round and walk to sit back down on the chair as quickly, safely and comfortably as they can. An assessor will start timing as the patient leans forward to stand up, and stop when the patient's hips make contact with the seat to sit down. An average of two repetitions will be analysed (Ko, Naylor, Harris, Crosbie, \& Yeo, 2013; Mizner et al., 2011; Podsiadlo \& Richardson, 1991).
Performance based measurements change in Six minute walk test
Time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
The test will measure how far patients can walk in 6 minutes along a level 25-metre footpath. Patients can use an assistive device if required, take a rest if necessary and have standardized encouragement after each minute. The assessor will ask the patient to stop after 6 minutes. Only one test will be performed to avoid fatigue ("ATS Statement," 2002; Ko et al., 2013; Mizner et al., 2011).
Balance change
Time frame: one week before admission day and 6 months after surgery to assess the balance changes post-surgery
In the Star Excursion Balance Test, three tape measures will be fixed to the clinic floor, one oriented anteriorly to the apex and two aligned at 135° to the anterior tape in the posterolateral and posteromedial directions. (Fullam, Caulfield, Coughlan, \& Delahunt, 2014). The patient will stand in the center of the grid and be instructed to stand on the affected or operated leg while reaching out as far as possible in one of the three directions with the other lower extremity, and then return that leg to the center. The participant will be asked to perform the test barefoot, keeping the heel of the stance leg on the floor at all times and to bend the knee of the stance leg. If the participant does not carry out any of these instructions, the trial will repeated. The assessor will measure the reach distance in each direction in centimeters and then normalize the average of the three trials to leg length.
Physical activity measurements change will be assess using an activPAL activity monitor (PAL Technologies, Glasgow, UK)
Time frame: one week before admission day and 6 months after surgery to assess the physical activity changes post-surgery
an activPAL activity monitor (PAL Technologies, Glasgow, UK) as this proven accelerometer provides objective quantification of free-living physical activity without any modification (Dahlgren, Carlsson, Moorhead, Hager-Ross, \& McDonough, 2010; Schmalzried et al., 1998). It is suitable as it light in weight (20g), includes an inclinometer and is small in size (53 x 35 x 7 mm) Figure 3. The device is worn by patient's mid-thigh, secured by non-allergic waterproof adhesive tape under their clothes, for 7-10 days before surgery and 6 months after. Clear written and verbal instructions will be given to patients as they have to wear it all day and all night except, when bathing or swimming (they can take a shower with it on).
2 secondary outcomes
Arabic versions of Oxford Knee Score Validity assessment
Time frame: one week before admission day
Arabic versions of Oxford Knee Score Reliability assessment
Time frame: one week before admission day, admission day and 6 months after surgery and to evaluate the construct validity of the Arabic version of Oxford Knee Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 20710093Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.
- Background: PubMed 22539338Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.
- Background: PubMed 11547372Bullens PH, van Loon CJ, de Waal Malefijt MC, Laan RF, Veth RP. Patient satisfaction after total knee arthroplasty: a comparison between subjective and objective outcome assessments. J Arthroplasty. 2001 Sep;16(6):740-7. doi: 10.1054/arth.2001.23922.
- Background: PubMed 22398175Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
- Background: PubMed 16536104Charoencholvanich K, Pongcharoen B. Oxford knee score and SF-36: translation & reliability for use with total knee arthroscopy patients in Thailand. J Med Assoc Thai. 2005 Sep;88(9):1194-202.
- Background: PubMed 22889651Coughlan GF, Fullam K, Delahunt E, Gissane C, Caulfield BM. A comparison between performance on selected directions of the star excursion balance test and the Y balance test. J Athl Train. 2012 Jul-Aug;47(4):366-71. doi: 10.4085/1062-6050-47.4.03.
- Background: PubMed 20655228Dahlgren G, Carlsson D, Moorhead A, Hager-Ross C, McDonough SM. Test-retest reliability of step counts with the ActivPAL device in common daily activities. Gait Posture. 2010 Jul;32(3):386-90. doi: 10.1016/j.gaitpost.2010.06.022. Epub 2010 Jul 22.
- Background: PubMed 23680877Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- BackgroundField, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.
- Background: PubMed 23945793Fullam K, Caulfield B, Coughlan GF, Delahunt E. Kinematic analysis of selected reach directions of the Star Excursion Balance Test compared with the Y-Balance Test. J Sport Rehabil. 2014 Feb;23(1):27-35. doi: 10.1123/jsr.2012-0114. Epub 2013 Aug 12.
- Background: PubMed 18697226Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery of the hip or knee. Physiother Res Int. 2008 Sep;13(3):141-52. doi: 10.1002/pri.411.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by University of Salford at 1 site in Saudi Arabia.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance based measurements change in Thirty second chair-stand test (time frame: one week before admission day and 6 months after surgery to assess the performance changes post-surgery). The study lists 6 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 NCT02998125, which also lists 39 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 May 2020.