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Clinical Trials/NCT03615638
NCT03615638
Unknown
Not Applicable

Effectiveness of a Community-based Post-operative Rehabilitation and Fall Prevention Program Following Total Knee Arthroplasty - a Randomized Controlled Trial

The Hong Kong Polytechnic University2 sites in 1 country78 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
The Hong Kong Polytechnic University
Enrollment
78
Locations
2
Primary Endpoint
Chinese version of Knee Injury and Osteoarthritis Outcome Scale
Last Updated
5 years ago

Overview

Brief Summary

Knee osteoarthritis (OA) is a common musculoskeletal disorder among older people. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population.

Total knee arthroplasty (TKA) is used to treat patients with severe knee OA. While TKA has been shown to improve knee pain, function and quality of life of patients with knee OA, up to 50% of patients with post-TKA may suffer from falls within in the first year after TKA. Given that Tai Chi can significantly improve the balance and function of older people, a fall prevention program may improve balance, pain, and function of post-TKA patients.

As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA against a group of TKA patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Detailed Description

Osteoarthritis (OA) is the third most disabling musculoskeletal compliant in the world. Knee OA is the most common type of OA. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population. Total knee arthroplasty (TKA) is a surgical intervention for treating patients with severe knee OA. Research has found that TKA reduces knee pain, and improves patient's function and quality of life. However, studies have also found that patients with post-TKA may be more likely to fall as compared to age- and gender-matched asymptomatic counterparts. It is estimated that around 20% to 50% of patients fall within in the first year after TKA. As such, it is essential to improve the balance of post-TKA patients. Studies have found that Tai Chi can significantly improve the balance and function of older people. Therefore, a fall prevention program aiming at strengthening, proprioception, balance training, and behavioral modification may improve balance, pain, and function of post-TKA patients. As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA with a group of patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Arnold Wong Yu Lok

Assistant Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

  • Participants undergoing TKA for intervention group and usual postoperative care group
  • Age- and gender-matched asymptomatic controls without knee pain in the last 12 months.
  • Can speak and understand Cantonese/English.

Exclusion Criteria

  • Living in assisted living facilities, requiring nursing care
  • Medical 'red flag' conditions
  • A history of cancer in the last five years
  • Cauda equine syndrome
  • Knee fracture
  • Auto-immune disease (e.g. rheumatoid arthritis) even if they have OA
  • Inflammatory or septic arthritis
  • Systemic disease
  • Amputation
  • History of orthopedic or neurological surgery to the spine, pelvis or hips

Outcomes

Primary Outcomes

Chinese version of Knee Injury and Osteoarthritis Outcome Scale

Time Frame: 1 year

A 42-item questionnaire with 5 subscales to assess pain, symptoms, activities of daily living, sports and recreation function, and knee-related quality of life

Secondary Outcomes

  • Chinese version Falls Efficacy Scale - International(1 year)
  • Chinese version geriatric depression scale(1 year)
  • Number of post-operative trips/falls(1 year)
  • Physical Activity Scale for the Elderly(1 year)
  • 11-point numeric pain rating scale(1 year)
  • Chinese version Insomnia Severity Index(1 year)

Study Sites (2)

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