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Completed

NCT Number: NCT02381873

Determinants of Early Functional Outcome After Reconstructive Surgery

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Neuromuscular performance capability

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

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

  2. Sensorimotor performance capability

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

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

  3. International Physical Activity Questionnaire (IPAQ).

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

    Self-reported physical activity will be monitored using IPAQ.

  4. Knee circumference

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

  5. DNA genotypes and subsequent protein expression

    Time frame: on the day of surgery and 12 weeks following operation

  6. Psychophysiological response

    Time frame: from 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.

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2015
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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