An Exploration of Outcomes Post-total Knee Arthroplasty in Middle East
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|ClinicalTrials.gov Identifier: NCT02998125|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : May 3, 2018
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.
|Condition or disease||Intervention/treatment|
|Total Knee Arthroplasty||Procedure: Total knee arthroplasty|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||October 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
before and after total knee arthroplasty
assess the functional outcome before and 6 months after total knee arthroplasty
Procedure: Total knee arthroplasty
prospective assessments for the functional outcome before and after the total knee arthroplasty
- 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).
- Arabic versions of Oxford Knee Score Validity assessment [ Time Frame: one week before admission day ]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
- 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 ]Patients will be asked to fill out Arabic forms independently without any interpretation to assess the Score reliability and responsiveness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998125
|Contact: Bodor Bin sheeha, MScfirstname.lastname@example.org|
|Contact: Richard Jones, Professoremail@example.com|
|King Khalid University Hospital||Recruiting|
|Riyadh, Saudi Arabia|
|Contact: Ahmad Bin nasser, PhD 0096611467 0000 ext 1020 firstname.lastname@example.org|
|Principal Investigator: Bodor H Bin Sheeha, MSc|