MedPath

Determinants of Early Functional Outcome After Reconstructive Surgery

Completed
Conditions
Osteoarthritis
Registration Number
NCT02381873
Lead Sponsor
Queen Margaret University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Knee Injury and Osteoarthritis Score (KOOS)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)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 platefrom 10 weeks prior to surgery to 12 weeks after surgery

Postural stability will be assessed using a stable force plate.

Secondary Outcome Measures
NameTimeMethod
Neuromuscular performance capabilityfrom 10 weeks prior to surgery to 12 weeks after surgery

Dynamometer and electromyography measurements will be used to evaluate neuromuscular performance capability.

Sensorimotor performance capabilityfrom 10 weeks prior to surgery to 12 weeks after surgery

Dynamometer and electromyography measurements will be used to evaluate sensorimotor performance capability.

International Physical Activity Questionnaire (IPAQ).from 10 weeks prior to surgery to 12 weeks after surgery

Self-reported physical activity will be monitored using IPAQ.

Knee circumferencefrom 10 weeks prior to surgery to 12 weeks after surgery
DNA genotypes and subsequent protein expressionon the day of surgery and 12 weeks following operation
Psychophysiological responsefrom 10 weeks prior to surgery to 12 weeks after surgery

Self reported. Psychophysiological response will be assessed using Category-Ratio Scale (CR-10); performance profile; short form (SF)-36.

Trial Locations

Locations (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

🇬🇧

Oswestry, Shropshire, United Kingdom

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