An Exploration of Outcomes Post-total Knee Arthroplasty in Middle East

NCT02998125 | Completed DMC

• 1 other identifier: USalford-Bsheeha
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  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).

  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).

  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.

  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).

  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

  one week before admission day

• Arabic versions of Oxford Knee Score Reliability assessment

  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

Study Arms (1)

before and after total knee arthroplasty

assess the functional outcome before and 6 months after total knee arthroplasty

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

prospective assessments for the functional outcome before and after the total knee arthroplasty

before and after total knee arthroplasty

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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,

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Salford: lead
• King Khalid University Hospital: collaborator
• Princess Nourah Bint Abdulrahman University: collaborator

Study Sites (1)

King Khalid University Hospital

Riyadh, Saudi Arabia

Location

Related Publications (39)

• 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.

  PMID: 12091180 BACKGROUND

• Bade 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.

  PMID: 20710093 BACKGROUND

• Bade 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.

  PMID: 22539338 BACKGROUND

• Bullens 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.

  PMID: 11547372 BACKGROUND

• Carr 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.

  PMID: 22398175 BACKGROUND

• Charoencholvanich 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.

  PMID: 16536104 BACKGROUND

• Coughlan 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.

  PMID: 22889651 BACKGROUND

• Dahlgren 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.

  PMID: 20655228 BACKGROUND

• Dobson 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.

  PMID: 23680877 BACKGROUND

• Field, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.

  BACKGROUND

• 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.

  PMID: 23945793 BACKGROUND

• Gill 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.

  PMID: 18697226 BACKGROUND

• Gribble 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.

  PMID: 22892416 BACKGROUND

• Harris 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.

  PMID: 23526094 BACKGROUND

• Hertel 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.

  PMID: 16596889 BACKGROUND

• Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: are we there yet? Bone Joint J. 2015 Jan;97-B(1):3-9. doi: 10.1302/0301-620X.97B1.34434.

  PMID: 25568406 BACKGROUND

• Hossain FS, Patel S, Fernandez MA, Konan S, Haddad FS. A performance based patient outcome score for active patients following total knee arthroplasty. Osteoarthritis Cartilage. 2013 Jan;21(1):51-9. doi: 10.1016/j.joca.2012.09.019. Epub 2012 Oct 9.

  PMID: 23063619 BACKGROUND

• Hyong IH, Kim JH. Test of intrarater and interrater reliability for the star excursion balance test. J Phys Ther Sci. 2014 Aug;26(8):1139-41. doi: 10.1589/jpts.26.1139. Epub 2014 Aug 30.

  PMID: 25202168 BACKGROUND

• Impellizzeri FM, Mannion AF, Leunig M, Bizzini M, Naal FD. Comparison of the reliability, responsiveness, and construct validity of 4 different questionnaires for evaluating outcomes after total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):861-9. doi: 10.1016/j.arth.2010.07.027. Epub 2010 Nov 12.

  PMID: 21074964 BACKGROUND

• Jagger, C., Matthews, R., Spiers, N., Brayne, C., Comas - Herrera, A., Robinson, T., . . . Croft, P. (2006). Compression or expansion of disability?: forecasting future disability levels under changing patterns of diseases: King's Fund.

  BACKGROUND

• Jenny JY, Diesinger Y. Validation of a French version of the Oxford knee questionnaire. Orthop Traumatol Surg Res. 2011 May;97(3):267-71. doi: 10.1016/j.otsr.2010.07.009. Epub 2011 Jan 12.

  PMID: 21233035 BACKGROUND

• Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.

  PMID: 15679884 BACKGROUND

• Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1.

  PMID: 24269097 BACKGROUND

• Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.

  PMID: 23617377 BACKGROUND

• Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299.

  PMID: 25201448 BACKGROUND

• Lutzner C, Kirschner S, Lutzner J. Patient activity after TKA depends on patient-specific parameters. Clin Orthop Relat Res. 2014 Dec;472(12):3933-40. doi: 10.1007/s11999-014-3813-5. Epub 2014 Jul 23.

  PMID: 25053290 BACKGROUND

• McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014 Mar;67(3):267-77. doi: 10.1016/j.jclinepi.2013.08.015. Epub 2013 Nov 22.

  PMID: 24275499 BACKGROUND

• Meiring RM, Frimpong E, Mokete L, Pietrzak J, Van Der Jagt D, Tikly M, McVeigh JA. Rationale, design and protocol of a longitudinal study assessing the effect of total knee arthroplasty on habitual physical activity and sedentary behavior in adults with osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:281. doi: 10.1186/s12891-016-1141-5.

  PMID: 27411316 BACKGROUND

• Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.

  PMID: 20851566 BACKGROUND

• Naal FD, Impellizzeri FM, Sieverding M, Loibl M, von Knoch F, Mannion AF, Leunig M, Munzinger U. The 12-item Oxford Knee Score: cross-cultural adaptation into German and assessment of its psychometric properties in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Jan;17(1):49-52. doi: 10.1016/j.joca.2008.05.017. Epub 2008 Jul 7.

  PMID: 18602843 BACKGROUND

• Palmer CR. Encyclopedia of biostatistics. BMJ. 1999 Feb 20;318(7182):542. doi: 10.1136/bmj.318.7182.542. No abstract available.

  PMID: 10024284 BACKGROUND

• Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.

  PMID: 26224824 BACKGROUND

• Plichta, S., & Kelvin, E. (2012). Munro's Statistical Methods for Health Care Research: Lippincott Williams & Wilkins.

  BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Robinson RH, Gribble PA. Support for a reduction in the number of trials needed for the star excursion balance test. Arch Phys Med Rehabil. 2008 Feb;89(2):364-70. doi: 10.1016/j.apmr.2007.08.139.

  PMID: 18226664 BACKGROUND

• Schmalzried TP, Szuszczewicz ES, Northfield MR, Akizuki KH, Frankel RE, Belcher G, Amstutz HC. Quantitative assessment of walking activity after total hip or knee replacement. J Bone Joint Surg Am. 1998 Jan;80(1):54-9.

  PMID: 9469309 BACKGROUND

• Stratford PW, Kennedy DM. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol. 2006 Feb;59(2):160-7. doi: 10.1016/j.jclinepi.2005.07.012. Epub 2005 Dec 27.

  PMID: 16426951 BACKGROUND

• Thumboo J, Chew LH, Lewin-Koh SC. Socioeconomic and psychosocial factors influence pain or physical function in Asian patients with knee or hip osteoarthritis. Ann Rheum Dis. 2002 Nov;61(11):1017-20. doi: 10.1136/ard.61.11.1017.

  PMID: 12379527 BACKGROUND

• Unver B, Kalkan S, Yuksel E, Kahraman T, Karatosun V. Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015 Jul-Aug;23(4):184-7. doi: 10.1590/1413-78522015230401018.

  PMID: 26327798 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student at University of Salford

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 20, 2016
• Study Start: March 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: February 18, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)