ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02998125
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
King Khalid University Hospital
Princess Nourah Bint Abdulrahman University
Information provided by (Responsible Party):
Bodor Bin sheeha, University of Salford

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.


Condition or disease Intervention/treatment
Total Knee Arthroplasty Procedure: Total knee arthroplasty

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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).

  4. 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).

  5. 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.


  6. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The present study is a prospective randomized six-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.

Criteria

Inclusion Criteria:

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,

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Bodor Bin sheeha, MSc 00447454787755 b.binsheeha@edu.salford.ac.uk
Contact: Richard Jones, Professor 00441612952295 r.k.jones@salford.ac.uk

Locations
Saudi Arabia
King Khalid University Hospital Recruiting
Riyadh, Saudi Arabia
Contact: Ahmad Bin nasser, PhD    0096611467 0000 ext 1020    abinnasser@ksu.edu.sa   
Principal Investigator: Bodor H Bin Sheeha, MSc         
Sponsors and Collaborators
University of Salford
King Khalid University Hospital
Princess Nourah Bint Abdulrahman University

Publications:
Field, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.
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.
Plichta, S., & Kelvin, E. (2012). Munro's Statistical Methods for Health Care Research: Lippincott Williams & Wilkins.

Responsible Party: Bodor Bin sheeha, PhD student at University of Salford, University of Salford
ClinicalTrials.gov Identifier: NCT02998125     History of Changes
Other Study ID Numbers: USalford-Bsheeha
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No