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Clinical Trials/NCT02381873
NCT02381873
Completed
Not Applicable

Exploratory Study of Determinants of Early Functional Outcome Following Reconstructive Knee Surgery

Queen Margaret University1 site in 1 country36 target enrollmentFebruary 2015
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Queen Margaret University
Enrollment
36
Locations
1
Primary Endpoint
Knee Injury and Osteoarthritis Score (KOOS)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This exploratory study will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological and genotypical performance capabilities and levels of habitual physical activity prior to and around the time of surgery.

Detailed Description

Despite the positive outcomes of total knee arthroplasty (TKA) surgery on symptoms such as pain, perceived function and health-related quality of life (QoL) current research highlights the persistent deleterious effects of retained aberrant neuromuscular alterations on physical function, which may also directly impact falls risk. Importantly, observed increases in neuromuscular deficits that occur prior to surgery track through into the post-operative stage with functional limitations that are sustained and which can persist at least one year after surgery. Clearly, it is crucial to strive to identify modifiable factors that might successfully ameliorate this pathophysiological process prior to surgery, reduce post surgical impairments and which also accelerate recovery. Among other determinants that might contribute towards understanding of optimal functional recovery following reconstructive knee surgery is the influence of genes. The evaluation of specific genotypes and subsequent protein expression might provide further insight into the extent of genetic influence. For example, it is not yet known whether patients with specific genotypes experience an accelerated recovery. Currently, there is a paucity of research on the influence of gene-environment interactions on an individual's response to physical conditioning. The proposed research will be an exploratory study, involving four repeated-measures assessments from 10 weeks prior to surgery to 12 weeks after surgery. This study offers a novel evaluation of the overall patterning of changes and will quantify and describe patient-reported and objective measures of sensorimotor, neuromuscular, psychophysiological performance capabilities, genotypes and levels of habitual physical activity.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
March 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Peer

PhD Research Student

Queen Margaret University

Eligibility Criteria

Inclusion Criteria

  • Males and females over the age of 18, diagnosed with severe osteoarthritis and awaiting primary TKA.

Exclusion Criteria

  • Individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis
  • Rheumatic disorder
  • Other orthopaedic conditions affecting lower body function
  • Neurological disorders

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Score (KOOS)

Time Frame: from 10 weeks prior to surgery to 12 weeks after surgery

Self reported questionnaire which evaluates pain, other symptoms, function in activity of daily living, function in sport and recreation (Sport/Rec), and knee related QoL.

Oxford knee score (OKS)

Time Frame: from 10 weeks prior to surgery to 12 weeks after surgery

Self reported questionnaire which evaluates pain and function.

Postural stability as assesed by force plate

Time Frame: from 10 weeks prior to surgery to 12 weeks after surgery

Postural stability will be assessed using a stable force plate.

Secondary Outcomes

  • Neuromuscular performance capability(from 10 weeks prior to surgery to 12 weeks after surgery)
  • Sensorimotor performance capability(from 10 weeks prior to surgery to 12 weeks after surgery)
  • International Physical Activity Questionnaire (IPAQ).(from 10 weeks prior to surgery to 12 weeks after surgery)
  • Knee circumference(from 10 weeks prior to surgery to 12 weeks after surgery)
  • DNA genotypes and subsequent protein expression(on the day of surgery and 12 weeks following operation)
  • Psychophysiological response(from 10 weeks prior to surgery to 12 weeks after surgery)

Study Sites (1)

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