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

Sponsor
University of Salford (Other)
Overall Status
Completed
CT.gov ID
NCT02998125
Collaborator
King Khalid University Hospital (Other), Princess Nourah Bint Abdulrahman University (Other)
116
Enrollment
1
Location
35.6
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Total knee arthroplasty

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

Study Type:
Observational
Actual Enrollment :
116 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 :
Mar 1, 2017
Actual Primary Completion Date :
Dec 30, 2018
Actual Study Completion Date :
Feb 18, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Performance based measurements change in Thirty second chair-stand test [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 [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 [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 [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 [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Khalid University Hospital Riyadh Saudi Arabia

Sponsors and Collaborators

  • University of Salford
  • King Khalid University Hospital
  • Princess Nourah Bint Abdulrahman University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bodor Bin sheeha, PhD student at University of Salford, University of Salford
ClinicalTrials.gov Identifier:
NCT02998125
Other Study ID Numbers:
  • USalford-Bsheeha
First Posted:
Dec 20, 2016
Last Update Posted:
May 27, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of May 27, 2020