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Determinants of Early Functional Outcome After Reconstructive Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02381873
Enrollment
36
Registered
2015-03-06
Start date
2015-02-28
Completion date
2016-03-31
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Arthroplasty, Replacement, Knee, Osteoarthritis

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.

Interventions

None listed

Sponsors

Queen Margaret University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Knee Injury and Osteoarthritis Score (KOOS)from 10 weeks prior to surgery to 12 weeks after surgerySelf 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 surgerySelf reported questionnaire which evaluates pain and function.
Postural stability as assesed by force platefrom 10 weeks prior to surgery to 12 weeks after surgeryPostural stability will be assessed using a stable force plate.

Secondary

MeasureTime frameDescription
Knee circumferencefrom 10 weeks prior to surgery to 12 weeks after surgery
Neuromuscular performance capabilityfrom 10 weeks prior to surgery to 12 weeks after surgeryDynamometer and electromyography measurements will be used to evaluate neuromuscular performance capability.
Psychophysiological responsefrom 10 weeks prior to surgery to 12 weeks after surgerySelf reported. Psychophysiological response will be assessed using Category-Ratio Scale (CR-10); performance profile; short form (SF)-36.
DNA genotypes and subsequent protein expressionon the day of surgery and 12 weeks following operation
Sensorimotor performance capabilityfrom 10 weeks prior to surgery to 12 weeks after surgeryDynamometer 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 surgerySelf-reported physical activity will be monitored using IPAQ.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026